Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study

Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study Mette Bøymo Kaarbø, Kristine Grimen Danielsen, Gro Killi Haugstad, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-661042/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 23 Mar, 2022 Read the published version in Pilot and Feasibility Studies → Version 1 posted 11 You are reading this latest preprint version Abstract Background: Provoked vestibulodynia (PVD) is a prevalent chronic pain condition especially among young women. Pain is localized to the vulvar vestibule and is provoked by touch or pressure, such as penetrative intercourse. PVD can have profound consequences, adversely affecting a woman’s sexual life, relation to her partner and her psychological health. There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective interventions for this neglected women’s health condition. Aims: The primary aim of this study is to assess the feasibility of undertaking a full-scale RCT of somatocognitive therapy (SCT), a multimodal physiotherapy intervention, for women with PVD. The secondary aim is to evaluate implementation and acceptability of SCT and its potential treatment effectiveness in PVD. In the full-scale RCT SCT will be compared to standard PVD treatment. Methods: This multi-method feasibility study utilized a single subject study design with nested qualitative data. Ten women with PVD, aged 18-35, were recruited from the Vulva Clinic at Oslo University Hospital. The intervention took place at Oslo Metropolitan University. Participants were assessed at baseline, post-treatment and at the eight month’s follow-up with the tampon test and self-report questionnaires. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools and follow-up rate. The participants’ experiences with the primary outcome and the intervention were explored with semi-structured interviews. Results: Ten out of 18 eligible patients were recruited over 11 weeks. None were lost to follow-up. Adherence to self-report questionnaires was excellent. Adherence to tampon tests and to the reporting of treatments was good, whereas adherence to the 14-day diary was poor. No adverse events were reported. The tampon test was suboptimal as a primary outcome. SCT was found to be an acceptable treatment based on Global Perceived Effect scores and the participants’ experiences. Conclusion : The findings suggest that it is feasible to deliver a full-scale RCT of the SCT intervention for women with PVD. Some changes are suggested to optimize the protocol, such as increasing recruitment sites, change of primary outcome measure and adding a booster session. Trial registration : ClinicalTrials.gov NCT04208204, Registered December 23, 2019 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04208204 Internal Medicine provoked vestibulodynia vulvodynia vestibulitis somatocognitive therapy feasibility study Figures Figure 1 Key Messages What uncertainties existed regarding the feasibility? We wanted to investigate the recruitment and follow-up rates, adherence to outcomes, the primary outcome measure, adverse events, as well as the acceptability of SCT. What are the key findings? Follow-up rate, adherence to most outcomes, acceptability to SCT were judged to be feasible The tampon test is suboptimal as a primary outcome in PVD The feasibility of the recruitment was below the expected level What are the implications of the findings for the design of the main study? The findings suggest that it is feasible to deliver full scale RCT of the SCT intervention in this population, with some adjustments to the protocol: Include additional recruitment sites to optimize recruitment Replace the tampon test with the Female Sexual Function Index as a primary outcome Include a booster session six months post treatment Background Vulvodynia is a multifactorial vulvar pain condition of unknown cause. In the general population, the lifetime prevalence of vulvodynia is estimated between 7 and 16% ( 1 – 3 ) with a higher incidence amongst young women ( 4 , 5 ). Although prevalent, vulvodynia is a neglected women’s health condition, where empirically supported treatment guidelines are still lacking ( 6 ). The most common subtype of vulvodynia is provoked vestibulodynia (PVD) ( 7 ). In PVD, pain is localized to the vulvar vestibule and is provoked by touch or pressure such as sexual intercourse and tampon insertion. This pain condition represents the most common cause of painful intercourse ( 7 , 8 ), adversely affecting women’s quality of life ( 9 – 12 ), psychological health ( 13 , 14 ) and relation to their partners ( 15 ). The management of PVD is complex and challenging with several treatments available, including pharmacotherapy, surgical, physiotherapy and psychotherapy. Research evidence, however, is scarce regarding which treatment approach is the most effective. Although physiotherapy is a common first-line treatment for PVD, a systematic review highlighted the need for well-designed randomized controlled trials ( 16 ). Traditionally, physiotherapy treatments for PVD range from internal (vaginal) to external soft tissue mobilisations, joint manipulation, electrotherapy, therapeutic exercises and pelvic floor exercises ( 17 ). A recent multicenter randomized clinical trial (RCT) also found multimodal physiotherapy to be effective in the management of PVD ( 18 ). Somatocognitive therapy (SCT) is an existing multimodal physiotherapy intervention developed at Oslo University Hospital, Norway, in an attempt to alleviate the burden of longstanding pelvic and gynecological pains ( 19 – 21 ). In recent years, SCT has been modified and further developed to treat women with PVD, based on experiences from a pilot study ( 22 ), from PVD patients ( 23 ) and physiotherapy students treating PVD patients ( 24 ). Whereas multimodal physiotherapy treatments are usually provided by physiotherapists specialized in women’s health, SCT is intended to be implemented in primary care and designed to be easy to learn. Furthermore, this approach differs from other forms of physiotherapy for PVD by focusing somewhat less on pelvic floor rehabilitation. SCT is designed to target the multiple dimensions of vulvar pain utilizing a biopsychosocial approach, where the overall aim is to explore and improve body awareness, reduce vulvar pain and improve sexual function. Other essential components include cognitive strategies to improve coping with negative emotions and thoughts, and structured exposure to pain associated activities. In a recent systematic review on psychosocial factors a broader approach to PVD was supported ( 25 ). The primary aim of this Pro voked Lo calized Ve stibulodynia (ProLoVe) feasibility study is to assess the feasibility of undertaking a full-scale RCT of the SCT intervention for women with PVD. In the full-scale RCT, SCT will be compared to standard PVD treatment, of which the latter can include women’s health physiotherapy, topical or oral medication, sex therapy and/or psychological counseling. The main feasibility objectives will evaluate the recruitment rate, the follow-up rate, adherence to the data collection procedure and number of adverse events. In addition, this study will evaluate the tampon test ( 26 ) as a primary outcome measure in preparation for the main trial. The secondary aim is to evaluate implementation and acceptability of the intervention for the participants and to assess if SCT has the potential to reduce pain, pain catastrophizing and psychological distress, as well as improve sexual function. Methods Study design and procedure This multi-method feasibility study consisted of a single subject study design with nested qualitative data. Ten participants were recruited (February to April 2019) from from the Vulva Clinic, Department of Obstetrics and Gynecology, at Oslo University Hospital (OUH)). The SCT intervention took place in the outpatient clinic at the department of physiotherapy, at Oslo Metropolitan University. The trial consisted of three evaluation points: pre-treatment, post-treatment and eight months follow-up. In addition, the participants were interviewed twice; towards the end of the treatment period and one year later. Participant’s eligibility assessment was based on a comprehensive gynecologic examination and medical history using a standardized protocol for PVD diagnosis ( 27 ). Norwegian speaking women, aged 18–35, diagnosed with PVD, experiencing pain during 1) penetrative intercourse, 2) pressure applied to the vulvar vestibule or 3) usage of tampons, were eligible. Patients with an active infection or dermatologic disease in the vulvar region were excluded. Eligible patients were verbally informed about the study and received an information leaflet at the Vulva Clinic. Ten out of 18 eligible women contacted the primary investigator (last author) and received a detailed explanation about the study. All ten agreed to participate. Eight women however did not contact the primary investigator and reasons for this is unknown. Flow of participants through the study is presented in Fig. 1 . This study is not intended to be fully powered for detection of statistically significant effects. The research team therefore decided that ten participants would be an adequate sample size to give a preliminary understanding of the feasibility of undertaking a RCT of the SCT intervention. Research ethics The Regional Committee for Medical and Health Research Ethics in South East Norway (ref. no. 2018/1036, 01.10.18) approved the project. The trial was also registered at ClinicalTrials.gov under the identifier NCT04208204. All participants provided written informed consent prior to participation in this research. The trial is reported according to the Consolidated Standards of Reporting Trial (CONSORT) 2010 statement: extension for pilot/feasibility studies (Additional file 1) ( 28 ). Data collection All quantitative data were collected via electronic forms and directly transferred in a secured manner to the Services for Sensitive Data (TSD) research server. Qualitative interviews were recorded with Dictaphone app, which insured immediate and direct transfer of the files to the TSD research server. The qualitative data collected through interviews was transcribed verbatim and uploaded into NVivo 12. The patients received several electronic assessment packages throughout the study. There were three main assessment time points, baseline, post treatment and eight months follow-up. Assessment packages at baseline, post treatment and eight months follow-up Assessment package 1 The participants received an electronic link to the main questionnaire package which included sociodemographic and clinical characteristics and a battery of self-reported questionnaires including Female Sexual Function Index ( 29 ), Pain Catastrophizing Scale ( 30 ) and Hopkins Symptom Check List- 25 ( 31 ). Details of these measures are included in additional file 2. Information about age, number of children, relationship status, education, work status, use of analgesics, body mass index, exercise and intercourse frequency in the last four weeks was collected at baseline. Assessment package 2 baseline tampon test undertaken in the evening on day 1, 7 and 14 to measure vulvar pain intensity using the Numeric Rating Scale (NRS) (0–10), where a score of zero represented no pain and 10 meaning the worst possible pain. Assessment package 3 a 14-day diary ( 32 ), an index of emotional instability , to assess day to day variance in emotional states. Registration of received treatment Assessment package 4 Participants received bi-weekly electronic forms up until the 8 months follow-up recording all treatments received for PVD in the past 14 days. This included all visits to various health professionals, use of medication and number of sick leave days. In the full-scale RCT this information will be used to determine what kind of treatments the participants will be receiving and to conduct cost-effectiveness analysis. Tampon test as primary outcome measure One of the aims of this feasibility study was to evaluate the tampon test as the primary outcome measure. The tampon test was chosen as a primary outcome based on recommendations for self-report outcome measures in vulvodynia clinical trials ( 33 ). This test has been used as a primary outcome measure in various clinical trials for vulvodynia, evaluating the effect of various treatments ( 34 – 40 ). It is an alternative measure for pain associated with vulvovaginal penetration and allows the inclusion of women with PVD who are unable to have intercourse. The test has demonstrated good construct validity and reliability ( 26 ). In this study, all women were provided with the same type of tampon as the validity study, the original Regular Tampax™ Tampons ( 26 ). Participants were provided with detailed instructions about how to undertake and record the tampon test, as described by Foster et al (2009). The participants recorded the degree of pain on the entire tampon insertion and removal experience on the NRS. Qualitative interviews All participants were interviewed one-to-one towards the end of the treatment period. Seven of the women also agreed to take part in a follow-up interview one year later. A phenomenological worldview informed the qualitative approach, where the aim was to explore and give voice to the subjects’ perspectives and lived experiences ( 41 ). The second author, a female physiotherapist experienced with qualitative interviews conducted the interviews and was not involved in the delivery of the treatment. During the first round of interviews, each interview took place in the physiotherapy outpatient clinic at Oslo Metropolitan University. The second interview round was conducted using Zoom, a video meeting platform, due to the Covid-19 restrictions. Each interview lasted 60–90 minutes. A semi-structured interview guide was used to ensure each area of interest was addressed during the interviews, while at the same time encouraging the women to speak freely about their experiences ( 41 ). The interviewer introduced the central topics with open-ended questions, asking the participants to share their experiences with the outcome measures and their experiences with SCT. To elicit rich descriptions, the interviewer tried to follow up salient cues and themes in the participants’ answers, inviting them to elaborate, provide examples, or to clarify where appropriate. The interviewer was on the lookout for variations, different angles and conflicting viewpoints, to promote a nuanced data material ( 41 ). Intervention In recent years, SCT has been developed to treat women with PVD ( 23 , 24 , 42 – 44 ). SCT is a multimodal physiotherapy treatment approach previously shown to be effective in the treatment of chronic pelvic pain ( 19 – 21 ). In Table 1 an overview of the intervention is presented as it was provided in this trial, utilizing the template for intervention description and replication TIDierR ( 45 ). The intervention was conducted by the first author, an experienced female physiotherapist trained in SCT. Table 1 Overview of somatocognitive therapy as provided in the feasibility study, as per TIDierR Criteria TIDierR Items (45) Description Brief name Somatocognitive therapy for Provoked Localized Vestibulodynia (ProLoVe feasibility study) Why Few RCTs exist, important to develop effective treatments that can easily be applied in primary care. Running a feasibility study is important in preparation for full-scale RCT. What SCT is a multimodal physiotherapy intervention designed to target the multiple dimensions of vulvar pain utilizing a biopsychosocial approach. A bodily approach is combined with cognitive restructuring of negative thoughts. Overall, the aim is to improve body awareness to reduce vulvar pain and psychological distress and improve sexual function. Materials; Participants Resources: vulva.no Materials; Physiotherapist Equipment included a treatment bench, mat, pillows, massage balls, mirror, Pilates ball and education material. Procedures Initial appointment: Assess participant – take a thorough history (including previous experiences, beliefs and expectations) and clinical examination, (quality of movement, breathing pattern). The main areas of SCT include: Therapeutic alliance is an essential component of SCT; patient and therapist are in a close working relationship, agreeing on treatment goals and home assignments. Participants take an active part in the decision-making process about their own treatment and progression. The bodily approach : breathing patterns, maladaptive movement and postural patterns are addressed in various positions (sitting, standing, walking and in supine). Through manual techniques and touch participants are taught various techniques to increase body awareness, improve relaxation and reduce muscle tension. Education about PVD, chronic pain, stress and healthy vulvo–vaginal and sexual behaviors. Coping with emotions and thoughts related to bodily experiences. Participant learns to become aware of negative/catastrophizing thoughts and learns how to restructure or accept these thoughts as well as how to overcome fear avoidance behavior. An important aspect is the women’s ability to adapt and to self-manage their condition such as coping with pain and flare-ups. Structured homework promoting the application of learned techniques in daily situations. Gradual exposure to activities associated with pain, desensitization exercises and exercises to increase pelvic floor and vulva awareness. Relaxation and breathing exercises. Last session – create a self-management toolbox with participant Who provides Experienced female physiotherapist trained in SCT, first author of article. How Each session has a three phased structure: 1) The conversation, 2) the bodily intervention/exploration and 3) the home assignment. Where In a closed room with access to gym, outpatient physiotherapy clinic, Oslo Metropolitan University, Norway Home assignments performed by the participants integrated into ADL When and how much Initial appointment offered to patients after collection of baseline data Median number of sessions: 12 (min 7; max 15) face to face with physiotherapist, Treatment period: minimum 13 weeks and maximum 22 weeks Each session (including initial session), lasted up to 60 minutes. The number of sessions required was personalized. Tailoring The treatment is personalized and tailored to the individual. Patient participation and collaboration is important. The treatment principles are the same for all but are adapted to suit the individual’s needs. Study outcomes Primary feasibility outcomes The primary aim of this study was to evaluate the feasibility of undertaking a full-scale RCT of SCT for women with PVD. This trial measured several feasibility outcomes in preparation for the main trial. These included: Recruitment rate . This was defined as the number of eligible patients and number of recruited participants per week within a period of five months. The follow-up response rate . This was measured by the percentage of participants who were followed up successfully until the eight months follow-up. Adherence to completion of outcomes . Adherence was defined as the number of participants who fully completed the battery of self-reported questionnaires, the 14-day diary, the number of performed tampon tests and biweekly forms about the received treatment, within a time frame of eight months. Evaluation of the utility value of the tampon test as a primary outcome measure based on tampon test data and the participant’s experiences with the tampon test (reported in separate mixed methods study ( 46 ). Reporting of adverse events . An event was recorded as adverse if a participant was pulled out of the study because SCT was deemed as an inappropriate treatment. Secondary outcomes The secondary aim of this study was to test the implementation and acceptability of the somatocognitive intervention utilising both quantitative and qualitative data. The 6-point Global Perceived Effect (GPE) scale was used to provide quantitative estimation of participants' perceived effect with the treatment directly after treatment and at the eight months follow-up ( 47 ). The participants were asked “Overall, how much did the treatment you received help your problems?”. The scale ranges from one to six; very much better, much better, a little better, no change, much worse and very much worse. During the semi-structured interviews, participants were asked about their experiences with SCT intervention, both towards the end of the treatment period and one year later. In addition, the aim was to evaluate if SCT has the potential to reduce pain, pain catastrophizing and psychological distress, as well as the potential to improve sexual function. A description of the self-reported outcome measures is provided in additional file 2. Data analysis For the feasibility analysis, the results will be expressed as numbers referring to recruitment rate, follow-up, adherence and adverse events respectively. Descriptive statistics were used to assess the feasibility objectives and the self-reported outcomes using SPSS (version 27, IBM, Armonk, NY, United States of America) and Microsoft Excel (2016). Due to the nature of a feasibility study and the low number of participants, no hypothesis testing was performed, hence the continuous variables were presented with median and quartile values. In the qualitative phase a semantic thematic analysis was performed by the interviewer ( 48 ). Attentive reading and re-reading of the transcripts helped to discern central aspects in the women’s experiences and initial codes were identified. Taking care to include both common and diverging experiences, these initial codes were then reworked and organized into a map of themes and sub-themes related to experiences with outcome measures, the somatocognitive intervention and perceived benefits (included in additional file 3) The first and second author independently reviewed and revised the map for validity against the dataset until agreement between the authors was reached. The findings are presented as analytical summaries and illustrative quotes, which are fitted under relevant subheadings in the results section. All co-authors took part in the discussion of the final findings. Results Ten nulliparous women with PVD, median age 21 (18 to 33), participated in this feasibility study. The sociodemographic and clinical characteristics of the participants are presented in Table 2 . Seven of the women reported different comorbidities including jaw pain, muscle pain and twitching, anal pain, endometriosis, headache, migraine, fibromyalgia, irritable bowel syndrome and alopecia areata. Overall, the women were physically active, exercising from one to three times per week for 30–60 minutes at moderate to high intensity levels. Only one reported never exercising. At baseline, four subjects were on oral contraceptives; one on cerazette, one on marvelon and two on oralcon. In terms of concurrent drug use all participants reported to have tried topical lidocaine. At baseline, six patients used topical lidocaine on a weekly to daily basis. In addition, one participant was on systemic treatment with amitriptyline, another on levothyroxine and one on diclofenac. Table 2 Sociodemographic and clinical characteristics of ten women with provoked vestibulodynia Characteristics Participants n = 10 Age (yrs.) , median (Q1; Q3) 21 (20; 26) Pain duration (yrs.) , median (Q1; Q3) 7 (3; 8) Primary PVD 7 Relationship category Married/common law 2 In a relationship 2 Single 6 Childbirth 0 Intercourse past 4 weeks 2 Education category High school student 1 Undergraduate student 7 Completed bachelor's degree 2 Work category Student 9 Part time work 5 Full time work 1 Unemployed 0 Participants with comorbidities 7 BMI, median (Q1; Q3) 23 (20; 23) Results of feasibility outcomes Recruitment rate Eighteen women were found eligible for participation, and ten women contacted the primary investigator and agreed to take part in the study. Ten participants were recruited over 11 weeks from the Vulva Clinic, achieving a recruitment rate of 0.9 participants per week. Recruitment was stopped when the targeted sample of ten participants was reached. Follow-up rate No participants were lost to follow-up. All the participants completed the SCT intervention and all partook at all measurement time points up until the eight months follow-up. Adherence to assessment procedures Overall adherence to the battery of self-report questionnaires was excellent, with all participants completing all the self-reported questionnaires at all three time points. In terms of adherence to the tampon tests across the three measurement time points, 81 out of 90 tampon tests were completed (90%). At baseline, there were nine full tampon test sets. Post treatment there were eight full tampon test sets and at the eight months follow-up there were six full tampon test sets. For the 14-day diary there were six full data sets at baseline, three post-treatment and two at the eight months follow-up. Regarding adherence to the bi-weekly forms about received treatments, two women did not record any of the SCT treatments, however all the other treatments received were recorded. Evaluation of the tampon test as the primary outcome measure Evaluation of the tampon test is reported in a separate paper ( 46 ). We concluded that the test may be suboptimal as a primary outcome measure in PVD research. The tampon test data demonstrated large intra- and inter-individual variability, furthermore the test seems to underestimate severity of pain in some women with PVD. Out of ten women with PVD, four of the women had an NRS score that was equal to, or below four, whilst concurrently reporting high levels of pain during sexual intercourse. Participants with low pain scores would be excluded from studies where the tampon test is part of the trial eligibility criteria, even though severe pain was experienced during sexual intercourse. Several women also reported in the interviews that they experienced the test as an inadequate measure of their problem ( 46 ). Reporting of adverse events There were no adverse events reported, i.e. no participants were pulled out of the study because SCT was considered as an inappropriate treatment. All participants turned up for their scheduled appointments and completed the intervention. Results of secondary outcomes Implementation and acceptability of somatocognitive therapy In this study the participants received a median number of 12 sessions. The SCT was personalized, hence the number of treatments delivered varied from seven up to a maximum of 15 sessions. In the original protocol, we stipulated that treatment duration would last for up to ten weeks. In this study, the treatment course lasted a minimum of 13 weeks and a maximum of 22 weeks. The frequency of the treatment delivery varied as it was personalized to the individual’s needs. Patients communicated to the therapist that they needed time to practice home assignments and incorporate what they had learnt into their ADL. Frequency of treatment was also influenced by external factors such as study and work commitments, exams, and holidays. Half of the participants were content with the number of treatment sessions received and felt ready to continue by themselves when the treatment period ended. The other half reported that they would have preferred a slightly longer treatment period. Several found it more difficult to keep motivated to prioritize their recovery process when their progress was no longer monitored by the therapist. P8: “Immediately after the treatment period ended it felt a bit tough. You receive such close guidance, and then you are suddenly alone with it again. I found it a bit difficult to keep my motivation up”. Most felt they would have benefited from one or two follow-up sessions a few months later, for repetition, motivation and guidance on how to move forward. P3: “Perhaps it could have been possible with a follow-up session six months later, in case things should get worse or you need some repetition, or when things have just been a little too much.” Participants’ perceived effect of SCT The GPE scale was used to provide quantitative estimation of participants’ perceived effect of the treatment measured directly after treatment and at eight months follow-up. Directly after treatment three women reported to be very much better , four reported to be much better and three reported a little better . At eight months follow-up one participant reported to be very much better , six participants reported much better , two reported a little better and one reported no change . Participants’ experiences with the intervention All participants expressed positive experiences with the SCT approach. They found it useful to learn techniques for deep breathing, relaxation, and self-management, as well as developing more constructive ways of thinking about and relating to their pain and sexuality. The participants largely expressed beliefs that PVD is complex and multidimensional in nature. They found it meaningful to combine physical and psychological aspects, and not exclusively focus on the painful vulvar area. P3: “I feel that somatocognitive therapy is more focused on the long-term recovery process. That it is easier to get lasting results when you not only treat the local muscles or problem area, but also include everything else around”. Furthermore, the importance of taking responsibility for their own recovery process was expressed by P6: “It makes so much sense that this is what I have to do. Not just talk about it and not just receive massage here or there. I have to make an active effort. Breathe. I have to relax”. Three participants however (P2, P7 and P9), felt the intervention would have benefitted from a specific focus on the vulvar area, including manual techniques to release tensions in the pelvic floor muscles. Most of the participants however, appreciated the gentle and desensitizing approach to the vulva. Several women also expressed that the encouragement to explore their own vulvas had helped them develop a more positive way of relating to this area. P4: I feel like I have made great improvements as before my vulva felt very unfamiliar, I just didn´t want to think about it. But now I actually feel that I have developed a completely different way of thinking about it and how it also is about being less afraid of the area”. The secondary aim of this study was to evaluate if SCT intervention had the potential to improve sexual function and reduce pain, pain catastrophizing and psychological distress. The women improved on all the outcome measures from baseline to post treatment, with a slight deterioration of the effect at the eight months follow-up. Table 3 includes all the measurements and number of participants who had experienced intercourse in the past four weeks, at the three time points. Table 3 Measurements at baseline, post-treatment and 8 months follow-up (n = 10), (none lost to follow-up) Pre-treatment Post-treatment 8 months follow-up Tampon test NRS (0–10), median (Q1; Q3) 4.5 (2.5; 6) 2 (1.5; 4.2) 3.5 (1.8; 4.5) Intercourse past 4 weeks, n 2 6 7 FSFI , median (Q1; Q3) Total sum (0–36) 14.8 (9.8; 19.8) 22.8 (15.8; 25.4) 20.9 (18; 27.1) Desire 2.1 (1.6; 3.2) 3.6 (2.3; 3.8) 3.6 (2.7; 4.3) Arousal 3.2 (1.6; 4.9) 4.4 (2.7; 5.7) 4.4 (3.0; 5.6) Lubrication 4.2 (2.9; 5.2) 4.8 (3.5; 5.8) 4.7 (3.6; 6.0) Orgasm 3.2 (0.9; 5.3) 4.8 (2.6; 5.3) 4.8 (1.2; 5.2) Satisfaction 0.8 (0.4; 2.0) 4.2 (1.1; 5.2) 3.8 (1.2; 5.3) Pain 0.0 (0.0; 0.3) 1.8 (0.0; 3.6) 2.0 (0.0; 3.6) PCS (0–52) , median (Q1; Q3) 20 (15.3; 29.3) 9.5 (5.3; 20) 12.5 (6.3; 22) HSCL-25 , median (Q1; Q3) 2.0 (1.7; 2.5) 1.6 (1.3; 2.4) 1.8 (1.6; 2.2) NRS: Numerical Rating Scale; (higher scores indicate more pain) FSFI: Female Sexual Function Index (higher scores indicate better sexual function); PCS: Pain Catastrophizing Scale (higher scores indicate higher levels of catastrophizing; HSCL-25: Hopkins Symptom Check List − 25 (higher scores indicate higher levels of psychological distress). Discussion This study was designed to assess the feasibility of running a full-scale RCT of the SCT intervention for women with PVD. In addition, the implementation and acceptability of SCT was evaluated, including its potential as a treatment for PVD. The current study demonstrated that the study was feasible with respect to follow-up rate and adherence to the assessment outcomes. We would argue that the intervention was acceptable based on Global Perceived Effect scores, the participants’ experiences with the intervention and the changes seen on the outcome measures. No adverse effects were reported. Based on the feasibility findings a few changes are suggested to optimize the protocol. In the following section the feasibility outcomes and secondary outcomes will be interpreted and further discussed. In terms of recruitment for the study, ten out of 18 patients were recruited over 11 weeks from one site, achieving a recruitment rate of 0.9 participants per week. To run a fully powered RCT with 130 patients, recruited in approximately 24 months, we will have to expand recruitment sites to other gynecologists experienced with PVD located at various clinics in the Oslo area. Feasibility outcomes related to follow-up rate and adherence was overall satisfactory. No participants were lost to follow-up and adherence to completion of the battery of self-reported questionnaires was excellent, with all ten participants fully completing the questionnaires. We demonstrated good adherence to the tampon test, with 81 out of 90 tampon tests completed (90%). Most of the missing tampon test data occurred at the eight months follow-up. The 14-day diary however, the Index of emotional instability , which was used to measure day-to-day variance in emotional states, had high levels of missing data. At the eight months follow-up there were only two complete 14-day diary sets, hence the diary will not be included in the main trial. During the interviews, many women found the diary time consuming and difficult to remember, and for some it also felt irrelevant. Adherence to the reporting of received treatment was satisfactory with eight full sets at the eight months follow-up. Two women did not record any of the physiotherapy treatments received, possibly due to a misunderstanding as all the other treatments they had received had been recorded. A further aim with this study was also to evaluate the feasibility of using the tampon test as a primary outcome measure. Many women with PVD abstain from penetrative intercourse and have difficulties with reporting pain. The tampon test was therefore chosen as a primary outcome measure as it was specifically designed to address this challenge ( 26 ). Based on the tampon test data and the participants’ experiences with the test and input from a user representative, we concluded in a separate paper ( 46 ) that the tampon test is suboptimal as a primary outcome measure in PVD research. Therefore, in the upcoming RCT, the primary outcome measure will be the Female Sexual Function Index (FSFI), while the tampon test will be applied as a secondary outcome. FSFI is widely used in PVD research ( 18 , 49 , 50 ). In addition to pain experienced during intercourse, it captures several other dimensions of sexual functioning. In this study the participants improved on average by 7.9 points (from 14.8 to 22.7 post treatment) and 6.1 points (from 14.8 to 20.9) at the eight months follow-up, when accounting for all subscales on the FSFI. We observed very similar magnitude of changes on all subscales, which conforms to the notion of a multidimensional nature of this disorder. In preparation for the upcoming main trial, the choice and implementation of outcome measures, including the FSFI, will be based on the findings from this feasibility study and Recommendations for the study of the vulvar pain in women, part I: review of assessment tools ( 51 ). Overall, we would argue that SCT is an acceptable and promising intervention. These findings are in line with previous studies evaluating the effect of SCT for women with chronic pelvic pain ( 19 – 21 ) and women with PVD ( 22 ). SCT is designed as a short-term therapy where one of the goals is to promote self-management of PVD and avoid over-treatment and therapist-dependency. Although approximately half the women were satisfied with the amount of treatment received, some expressed that the treatment ended too soon and described how a booster session would be valuable. This would provide an opportunity to receive support and guidance over time. Consequently in the future RCT, the participants will be offered one booster-session six months after the end of the treatment. Participants perceived effect was measured with the GPE and was further supported by the qualitative interviews with most women reporting a variety of improvements following the SCT intervention. In terms of pain reduction, most women described a recovery process characterized by periods of improvements and setbacks, but overall experienced a positive development. Meaningful changes also included improved body awareness; an improved ability to relax, feel more connected and comfortable in their own bodies. Several of the participants also described how the intervention had helped them develop a more neutral and less fearful way of thinking about their pain, which was also supported by the findings on the pain catastrophizing scale. Furthermore, the women had gained more healthy attitudes and strategies regarding their sexuality and some felt more confident involving their romantic partner in the recovery process. This study allows us tentatively to assess the effectiveness of the intervention in a small sample of participants. This study was not powered to detect changes over time and results should therefore be interpreted with caution. Albeit, all outcome measures pointed in the same direction, as the participants improved on the primary outcome, i.e. the tampon test, and all the secondary outcomes in the main questionnaire packet following SCT. The results indicate that the intervention has potential treatment effectiveness in a small sample of participants with PVD. Limitations of this study were the small sample and the lack of an active control group. In the main trial the SCT will be compared to standard treatment. A control group could have provided us with valuable information about the treatments delivered in this group, as well as the feasibility of the randomization process. The strength of this study is that both quantitative and qualitative methods were implemented to evaluate the feasibility and acceptability of SCT. Conclusion We conclude that it is feasible and practical to deliver a RCT of SCT, a multimodal physiotherapy intervention, in women with PVD. The aims of the feasibility study have been met, however some changes are suggested to optimize the study protocol, before conducting a full-scale RCT. This includes replacing the tampon test with the FSFI, increasing the recruitment sites and adding a booster session. Abbreviations FSFI: Female Sexual Function Index; HSCL-25: Hopkins Symptom Check List – 25; NRS: Numeric Rating Scale; PCS: Pain Catastrophizing Scale; PVD: Provoked Vestibulodynia; RCT: Randomized Clinical Trial; SCT: Somatocognitive Therapy Declarations Ethics approval and consent to participate: The Regional Committee for Medical Research Ethics in South East Norway (ref. no. 2018/1036) approved the project before the trial began. All patients gave their written informed consent after being provided verbal and written information. The trial adheres to the Declaration of Helsinki. Consent for publication: Consent to publish results were obtained from all participants. Availability of data and material: Anonymised individual-patient datasets are available from the corresponding author on reasonable request. Competing interests: The authors declare that they have no competing interests. Funding: Funding from Oslo Metropolitan University and the Norwegian Fund for Post-Graduate Training in Physiotherapy. The funding bodies had no role in the design of the study and collection, analysis and interpretation of data or in the writing of the manuscript. Authors’ contributions GKH, ALOH and SW conceptualized and designed the study. Acquisition of data was performed by MBK, KGD, ALOH and SW. MBK and KGD analyzed and interpreted the data. MBK drafted the manuscript, and KGD, GKH, ALOH and SW revised the manuscript for intellectual content. All authors read and approved the final manuscript. Acknowledgements We would like to thank all the patients who participated in this study. Author details 1 Department of Physiotherapy, Oslo Metropolitan University, Oslo, Norway; 2 Acute Psychiatric Department, Oslo University Hospital, Oslo, Norway; 3 Department of Obstetrics and Gynecology, Oslo University Hospital, Oslo, Norway; 4 Department of Dermatology, Oslo University Hospital, Oslo Norway; 5 Department of Neurology, Oslo University Hospital, Oslo Norway. References Harlow BL, Kunitz CG, Nguyen RH, Rydell SA, Turner RM, MacLehose RF. Prevalence of symptoms consistent with a diagnosis of vulvodynia: population-based estimates from 2 geographic regions. Am J Obstet Gynecol. 2014;210(1):40 e1–8. Gomez I, Coronado PJ, Martin CM, Alonso R, Guisasola-Campa FJ. Study on the prevalence and factors associated to vulvodynia in Spain. Eur J Obstet Gynecol Reprod Biol. 2019;240:121–4. Vieira-Baptista P, Lima-Silva J, Cavaco-Gomes J, Beires J. Prevalence of vulvodynia and risk factors for the condition in Portugal. Int J Gynecol Obstet. 2014;127(3):283–7. 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Mensendieck somatocognitive therapy as treatment approach to chronic pelvic pain: results of a randomized controlled intervention study. Am J Obstet Gynecol. 2006;194(5):1303–10. Haugstad GK, Haugstad TS, Kirste UM, Leganger S, Wojniusz S, Klemmetsen I, Malt UF. Continuing improvement of chronic pelvic pain in women after short-term Mensendieck somatocognitive therapy: results of a 1-year follow-up study. Am J Obstet Gynecol. 2008;199(6):615 e1–8. Haugstad GK, Wojniusz S, Kirschner R, Kirste U, Lilleheie I, Haugstad TS. Somatocognitive therapy of women with provoked vulvodynia: a pilot study. Scand J Pain. 2019;19(4):725–32. Groven KS, Raheim M, Hakonsen E, Haugstad GK. "Will I ever be a true woman?" An exploration of the experiences of women with vestibulodynia. Health Care Women Int. 2016;37(8):818–35. Fougner M, Haugstad GK. Treating gynaecological pain: the experiences of bachelor students in physiotherapy performing somatocognitive therapy. Physiother Theory Pract. 2015;31(5):318–26. Chisari C, Monajemi MB, Scott W, Moss-Morris R, McCracken LM. Psychosocial factors associated with pain and sexual function in women with Vulvodynia: A systematic review. Eur J Pain. 2021;25(1):39–50. Foster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, et al. The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009;113(4):825–32. Stockdale CK, Lawson HW. 2013 Vulvodynia Guideline Update. J Low Genit Tract Dis. 2014;18:93–100. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ (Clinical research ed). 2016;355. Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191–208. Fernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Disord. 2012;13:111. Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974;19(1):1–15. Rost S, Van Ryckeghem DML, Koval P, Sütterlin S, Vögele C, Crombez G. Affective instability in patients with chronic pain: a diary approach. Pain. 2016;157(8):1783–90. Pukall CF, Bergeron S, Brown C, Bachmann G, Wesselmann U, Group VCR. Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials. Clin J Pain. 2017;33(8):756–65. De Andres J, Sanchis-Lopez N, Asensio-Samper JM, Fabregat-Cid G, Dolz VM. Peripheral subcutaneous vulvar stimulation in the management of severe and refractory vulvodynia. Obstet Gynecol. 2013;121(2 Pt 2 Suppl 1):495–8. Phillips NA, Brown C, Foster D, Bachour C, Rawlinson L, Wan J, et al. Presenting symptoms among premenopausal and postmenopausal women with vulvodynia. Menopause. 2015;22(12):1296–300. Brown C, Bachmann GA, Wan J, Foster D. Pain Rating in Women with Provoked Vestibulodynia: Evaluating Influence of Race. J Womens Health. 2016;25(1):57–62. Brown CS, Bachmann GA, Wan J, Foster DC, Group GS. Gabapentin for the Treatment of Vulvodynia: A Randomized Controlled Trial. Obstet Gynecol. 2018;131(6):1000–7. Foster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, et al. Oral desipramine and topical lidocaine for vulvodynia: a randomized controlled trial. Obstet Gynecol. 2010;116(3):583–93. Guillet AD, Cirino NH, Hart KD, Leclair CM. Mindfulness-Based Group Cognitive Behavior Therapy for Provoked Localized Vulvodynia: A Randomized Controlled Trial. J Low Genit Tract Dis. 2019;23(2):170–5. Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med. 2017;14(11):1403–11. Kvale S, Brinkman S. Det kvalitative forskningsintervju (Interviews: Learning the craft of research interviewing). 2nd ed. ed. Oslo: Gyldendal Akademisk; 2009. Haugstad GK, Wojniusz S, Kirschner R, Kirste U, Lilleheie I, Haugstad TS. Somatocognitive therapy of women with provoked vulvodynia: a pilot study. Scand J Pain. 2019;19(4):725–32. Danielsen KG, Dahl-Michelsen T, Hakonsen E, Haugstad GK. Recovering from provoked vestibulodynia: Experiences from encounters with somatocognitive therapy. Physiother Theory Pract. 2018;23:1–10. Haugstad GK, Wojniusz S, Kirste UM, Kirschner RS, Lilleheie I, Haugstad TS. Pain, psychological distress and motor pattern in women with provoked vestibulodynia (PVD) – symptom characteristics and therapy suggestions. Scand J Pain. 2018;18(2):221–27. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. Kaarbø MB, Danielsen KG, Haugstad GK, Helgesen ALO, Wojniusz S. The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study. J Sex Med. 2021;18(6):1083–91. Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010;63(7):760-6.e1. Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. Smith KB, Pukall CF, Chamberlain SM. Sexual and relationship satisfaction and vestibular pain sensitivity among women with provoked vestibulodynia. J Sex Med. 2013;10(8):2009–23. Smith KB, Sadownik LA, Dargie E, Albert AYK, Brotto LA. Multidisciplinary Treatment for Provoked Vestibulodynia. Clin J Pain. 2019;35(4):335–44. Rosen NO, Bergeron S, Pukall CF. Recommendations for the Study of Vulvar Pain in Women, Part 1: Review of Assessment Tools. J Sex Med. 2020;17(2):180–94. Fernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Dis. 2012;13:111. Strand BH, Dalgard OS, Tambs K, Rognerud M. Measuring the mental health status of the Norwegian population: a comparison of the instruments SCL-25, SCL-10, SCL-5 and MHI-5 (SF-36). Nord J Psychiatry. 2003;57(2):113–8. Supplementary Files Supplementarymaterial.docx Cite Share Download PDF Status: Published Journal Publication published 23 Mar, 2022 Read the published version in Pilot and Feasibility Studies → Version 1 posted Editorial decision: Minor revision 12 Jan, 2022 Reviewer # 3 agreed at journal 21 Nov, 2021 Reviewer # 2 agreed at journal 27 Oct, 2021 Review # 1 received at journal 11 Aug, 2021 Reviews received at journal 30 Jul, 2021 Reviewer # 1 agreed at journal 29 Jul, 2021 Reviewers invited by journal 28 Jun, 2021 Editor assigned by journal 27 Jun, 2021 Submission checks completed at journal 27 Jun, 2021 Editor invited by journal 27 Jun, 2021 First submitted to journal 25 Jun, 2021 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-661042","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research","associatedPublications":[],"authors":[{"id":36094277,"identity":"ba43a42d-7bf2-4055-9240-be53d50488e6","order_by":0,"name":"Mette Bøymo Kaarbø","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2UlEQVRIiWNgGAWjYLACxgYGBn4gdYBI9cyMDSAtkkAM0iJBvBaDA8Rq0W3vP/7g4w6bxM3H2x8c+JhjU8cg3YzfgWZnDjM2zjyTlrjtzBmDgzO3pUkwyBxLwK/lRjJjM2/b4cRtN3IYDvNuOyzBIJFjgF/L/ceMzX+BWjbPSH8A1PKfCC03mBmbGYFaNkgkGAC1HCBCy5lkw5m9Z9KMZ0D8kizZJpFGwC/HDz748HOHjWx/e/vDBx+32fHzSyQfwKsFBhwbYCw2otQDgT2xCkfBKBgFo2AEAgCXgVCyRi7FFQAAAABJRU5ErkJggg==","orcid":"https://orcid.org/0000-0002-5879-8188","institution":"Oslo Metropolitan University: OsloMet - storbyuniversitetet","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Mette","middleName":"Bøymo","lastName":"Kaarbø","suffix":""},{"id":36094278,"identity":"eaedd090-a496-460f-a941-ad4162ba31b2","order_by":1,"name":"Kristine Grimen Danielsen","email":"","orcid":"","institution":"Oslo Metropolitan University Faculty of Health Sciences: OsloMet - storbyuniversitetet Fakultet for helsevitenskap","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Kristine","middleName":"Grimen","lastName":"Danielsen","suffix":""},{"id":36094279,"identity":"e347baee-51cd-400f-b828-6a3cd459aed2","order_by":2,"name":"Gro Killi Haugstad","email":"","orcid":"","institution":"Oslo Metropolitan University Faculty of Health Sciences: OsloMet - storbyuniversitetet Fakultet for helsevitenskap","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Gro","middleName":"Killi","lastName":"Haugstad","suffix":""},{"id":36094280,"identity":"5c738c94-f546-4160-9f04-c8dea38fb5c7","order_by":3,"name":"Anne Lise Ording Helgesen","email":"","orcid":"","institution":"Oslo University Hospital: Oslo Universitetssykehus","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Anne","middleName":"Lise Ording","lastName":"Helgesen","suffix":""},{"id":36094281,"identity":"d991707f-b5c6-41d8-a907-99d070813f74","order_by":4,"name":"Slawomir Wojniusz","email":"","orcid":"","institution":"Oslo Metropolitan University Faculty of Health Sciences: OsloMet - storbyuniversitetet Fakultet for helsevitenskap","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Slawomir","middleName":"","lastName":"Wojniusz","suffix":""}],"badges":[],"createdAt":"2021-06-26 17:31:41","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-661042/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-661042/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s40814-022-01022-2","type":"published","date":"2022-03-23T15:08:56+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":10963848,"identity":"210d194c-5833-420f-80b0-5afa3435619c","added_by":"auto","created_at":"2021-06-30 15:28:46","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":38791,"visible":true,"origin":"","legend":"CONSORT 2010 Flow diagram. Design and flow of participants through study","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-661042/v1/29ad8ce0a4ec965234a0aba8.png"},{"id":20460568,"identity":"0f65a52d-c6e6-4aee-8969-8895d0931202","added_by":"auto","created_at":"2022-04-18 15:08:59","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":684334,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-661042/v1/979d0e05-ebf4-4056-a44f-746ac0af9ad9.pdf"},{"id":10963849,"identity":"c9e8a85a-8eb4-48d5-ac45-2203d9a55106","added_by":"auto","created_at":"2021-06-30 15:28:46","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":55100,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementarymaterial.docx","url":"https://assets-eu.researchsquare.com/files/rs-661042/v1/f8a31baf4815fd35d2e1d20e.docx"}],"financialInterests":"","formattedTitle":"Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study","fulltext":[{"header":"Key Messages ","content":"\u003cp\u003e\u003cstrong\u003eWhat uncertainties existed regarding the feasibility?\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe wanted to investigate the\u0026nbsp;recruitment and follow-up rates, adherence to outcomes, the primary outcome measure, adverse events, as well as the acceptability of SCT.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWhat are the key findings?\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eFollow-up rate, adherence to most outcomes, acceptability to SCT were judged to be feasible\u003c/li\u003e\n \u003cli\u003eThe tampon test is suboptimal as a primary outcome in PVD\u003c/li\u003e\n \u003cli\u003eThe feasibility of the recruitment was below the expected level\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWhat are the implications of the findings for the design of the main study?\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe findings suggest that it is feasible to deliver full scale RCT of the SCT intervention in this population, with some adjustments to the protocol:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eInclude additional recruitment sites to optimize recruitment\u003c/li\u003e\n \u003cli\u003eReplace the tampon test with the Female Sexual Function Index as a primary outcome\u003c/li\u003e\n \u003cli\u003eInclude a booster session six months post treatment\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":" \u003cp\u003eVulvodynia is a multifactorial vulvar pain condition of unknown cause. In the general population, the lifetime prevalence of vulvodynia is estimated between 7 and 16% (\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) with a higher incidence amongst young women (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e). Although prevalent, vulvodynia is a neglected women\u0026rsquo;s health condition, where empirically supported treatment guidelines are still lacking (\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). The most common subtype of vulvodynia is provoked vestibulodynia (PVD) (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e). In PVD, pain is localized to the vulvar vestibule and is provoked by touch or pressure such as sexual intercourse and tampon insertion. This pain condition represents the most common cause of painful intercourse (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e), adversely affecting women\u0026rsquo;s quality of life (\u003cspan additionalcitationids=\"CR10 CR11\" citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e), psychological health (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) and relation to their partners (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe management of PVD is complex and challenging with several treatments available, including pharmacotherapy, surgical, physiotherapy and psychotherapy. Research evidence, however, is scarce regarding which treatment approach is the most effective. Although physiotherapy is a common first-line treatment for PVD, a systematic review highlighted the need for well-designed randomized controlled trials (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e). Traditionally, physiotherapy treatments for PVD range from internal (vaginal) to external soft tissue mobilisations, joint manipulation, electrotherapy, therapeutic exercises and pelvic floor exercises (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e). A recent multicenter randomized clinical trial (RCT) also found multimodal physiotherapy to be effective in the management of PVD (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eSomatocognitive therapy (SCT) is an existing multimodal physiotherapy intervention developed at Oslo University Hospital, Norway, in an attempt to alleviate the burden of longstanding pelvic and gynecological pains (\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). In recent years, SCT has been modified and further developed to treat women with PVD, based on experiences from a pilot study (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e), from PVD patients (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e) and physiotherapy students treating PVD patients (\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e). Whereas multimodal physiotherapy treatments are usually provided by physiotherapists specialized in women\u0026rsquo;s health, SCT is intended to be implemented in primary care and designed to be easy to learn. Furthermore, this approach differs from other forms of physiotherapy for PVD by focusing somewhat less on pelvic floor rehabilitation. SCT is designed to target the multiple dimensions of vulvar pain utilizing a biopsychosocial approach, where the overall aim is to explore and improve body awareness, reduce vulvar pain and improve sexual function. Other essential components include cognitive strategies to improve coping with negative emotions and thoughts, and structured exposure to pain associated activities. In a recent systematic review on psychosocial factors a broader approach to PVD was supported (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe primary aim of this \u003cb\u003ePro\u003c/b\u003evoked \u003cb\u003eLo\u003c/b\u003ecalized \u003cb\u003eVe\u003c/b\u003estibulodynia (ProLoVe) feasibility study is to assess the feasibility of undertaking a full-scale RCT of the SCT intervention for women with PVD. In the full-scale RCT, SCT will be compared to standard PVD treatment, of which the latter can include women\u0026rsquo;s health physiotherapy, topical or oral medication, sex therapy and/or psychological counseling. The main feasibility objectives will evaluate the recruitment rate, the follow-up rate, adherence to the data collection procedure and number of adverse events. In addition, this study will evaluate the tampon test (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) as a primary outcome measure in preparation for the main trial. The secondary aim is to evaluate implementation and acceptability of the intervention for the participants and to assess if SCT has the potential to reduce pain, pain catastrophizing and psychological distress, as well as improve sexual function.\u003c/p\u003e "},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section3\"\u003e \u003ch2\u003eStudy design and procedure\u003c/h2\u003e \u003cp\u003eThis multi-method feasibility study consisted of a single subject study design with nested qualitative data. Ten participants were recruited (February to April 2019) from from the Vulva Clinic, Department of Obstetrics and Gynecology, at Oslo University Hospital (OUH)). The SCT intervention took place in the outpatient clinic at the department of physiotherapy, at Oslo Metropolitan University. The trial consisted of three evaluation points: pre-treatment, post-treatment and eight months follow-up. In addition, the participants were interviewed twice; towards the end of the treatment period and one year later.\u003c/p\u003e \u003cp\u003eParticipant\u0026rsquo;s eligibility assessment was based on a comprehensive gynecologic examination and medical history using a standardized protocol for PVD diagnosis (\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e). Norwegian speaking women, aged 18\u0026ndash;35, diagnosed with PVD, experiencing pain during 1) penetrative intercourse, 2) pressure applied to the vulvar vestibule or 3) usage of tampons, were eligible. Patients with an active infection or dermatologic disease in the vulvar region were excluded. Eligible patients were verbally informed about the study and received an information leaflet at the Vulva Clinic. Ten out of 18 eligible women contacted the primary investigator (last author) and received a detailed explanation about the study. All ten agreed to participate. Eight women however did not contact the primary investigator and reasons for this is unknown. Flow of participants through the study is presented in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. This study is not intended to be fully powered for detection of statistically significant effects. The research team therefore decided that ten participants would be an adequate sample size to give a preliminary understanding of the feasibility of undertaking a RCT of the SCT intervention.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section3\"\u003e \u003ch2\u003eResearch ethics\u003c/h2\u003e \u003cp\u003e The Regional Committee for Medical and Health Research Ethics in South East Norway (ref. no. 2018/1036, 01.10.18) approved the project. The trial was also registered at ClinicalTrials.gov under the identifier NCT04208204. All participants provided written informed consent prior to participation in this research. The trial is reported according to the Consolidated Standards of Reporting Trial (CONSORT) 2010 statement: extension for pilot/feasibility studies (Additional file 1) (\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section3\"\u003e \u003ch2\u003eData collection\u003c/h2\u003e \u003cp\u003eAll quantitative data were collected via electronic forms and directly transferred in a secured manner to the Services for Sensitive Data (TSD) research server. Qualitative interviews were recorded with Dictaphone app, which insured immediate and direct transfer of the files to the TSD research server. The qualitative data collected through interviews was transcribed verbatim and uploaded into NVivo 12.\u003c/p\u003e \u003cp\u003eThe patients received several electronic assessment packages throughout the study. There were three main assessment time points, baseline, post treatment and eight months follow-up.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e \u003ch2\u003eAssessment packages at baseline, post treatment and eight months follow-up\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eAssessment package 1\u003c/strong\u003e \u003cp\u003eThe participants received an electronic link to the main questionnaire package which included sociodemographic and clinical characteristics and a battery of self-reported questionnaires including Female Sexual Function Index (\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e), Pain Catastrophizing Scale (\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e) and Hopkins Symptom Check List- 25 (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e). Details of these measures are included in additional file 2. Information about age, number of children, relationship status, education, work status, use of analgesics, body mass index, exercise and intercourse frequency in the last four weeks was collected at baseline.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAssessment package 2\u003c/strong\u003e \u003cp\u003ebaseline tampon test undertaken in the evening on day 1, 7 and 14 to measure vulvar pain intensity using the Numeric Rating Scale (NRS) (0\u0026ndash;10), where a score of zero represented no pain and 10 meaning the worst possible pain.\u003c/p\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eAssessment package 3\u003c/strong\u003e \u003cp\u003ea 14-day diary (\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e), an \u003cem\u003eindex of emotional instability\u003c/em\u003e, to assess day to day variance in emotional states.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section3\"\u003e \u003ch2\u003eRegistration of received treatment\u003c/h2\u003e \u003cp\u003e \u003cstrong\u003eAssessment package 4\u003c/strong\u003e \u003cp\u003eParticipants received bi-weekly electronic forms up until the 8 months follow-up recording all treatments received for PVD in the past 14 days. This included all visits to various health professionals, use of medication and number of sick leave days. In the full-scale RCT this information will be used to determine what kind of treatments the participants will be receiving and to conduct cost-effectiveness analysis.\u003c/p\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e \u003ch2\u003eTampon test as primary outcome measure\u003c/h2\u003e \u003cp\u003eOne of the aims of this feasibility study was to evaluate the tampon test as the primary outcome measure. The tampon test was chosen as a primary outcome based on recommendations for self-report outcome measures in vulvodynia clinical trials (\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e). This test has been used as a primary outcome measure in various clinical trials for vulvodynia, evaluating the effect of various treatments (\u003cspan additionalcitationids=\"CR35 CR36 CR37 CR38 CR39\" citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR40\" class=\"CitationRef\"\u003e40\u003c/span\u003e). It is an alternative measure for pain associated with vulvovaginal penetration and allows the inclusion of women with PVD who are unable to have intercourse. The test has demonstrated good construct validity and reliability (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). In this study, all women were provided with the same type of tampon as the validity study, the original Regular Tampax\u0026trade; Tampons (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). Participants were provided with detailed instructions about how to undertake and record the tampon test, as described by Foster et al (2009). The participants recorded the degree of pain on the entire tampon insertion and removal experience on the NRS.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003eQualitative interviews\u003c/h2\u003e \u003cp\u003eAll participants were interviewed one-to-one towards the end of the treatment period. Seven of the women also agreed to take part in a follow-up interview one year later. A phenomenological worldview informed the qualitative approach, where the aim was to explore and give voice to the subjects\u0026rsquo; perspectives and lived experiences (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e). The second author, a female physiotherapist experienced with qualitative interviews conducted the interviews and was not involved in the delivery of the treatment. During the first round of interviews, each interview took place in the physiotherapy outpatient clinic at Oslo Metropolitan University. The second interview round was conducted using Zoom, a video meeting platform, due to the Covid-19 restrictions. Each interview lasted 60\u0026ndash;90 minutes. A semi-structured interview guide was used to ensure each area of interest was addressed during the interviews, while at the same time encouraging the women to speak freely about their experiences (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e). The interviewer introduced the central topics with open-ended questions, asking the participants to share their experiences with the outcome measures and their experiences with SCT. To elicit rich descriptions, the interviewer tried to follow up salient cues and themes in the participants\u0026rsquo; answers, inviting them to elaborate, provide examples, or to clarify where appropriate. The interviewer was on the lookout for variations, different angles and conflicting viewpoints, to promote a nuanced data material (\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003eIntervention\u003c/h2\u003e \u003cp\u003eIn recent years, SCT has been developed to treat women with PVD (\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e, \u003cspan additionalcitationids=\"CR43\" citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e44\u003c/span\u003e). SCT is a multimodal physiotherapy treatment approach previously shown to be effective in the treatment of chronic pelvic pain (\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e). In Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e an overview of the intervention is presented as it was provided in this trial, utilizing the template for intervention description and replication TIDierR (\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e). The intervention was conducted by the first author, an experienced female physiotherapist trained in SCT.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOverview of somatocognitive therapy as provided in the feasibility study, as per TIDierR Criteria\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTIDierR Items (45)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDescription\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBrief name\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSomatocognitive therapy for Provoked Localized Vestibulodynia (ProLoVe feasibility study)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWhy\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFew RCTs exist, important to develop effective treatments that can easily be applied in primary care. Running a feasibility study is important in preparation for full-scale RCT.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWhat\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSCT is a multimodal physiotherapy intervention designed to target the multiple dimensions of vulvar pain utilizing a biopsychosocial approach. A bodily approach is combined with cognitive restructuring of negative thoughts.\u003c/p\u003e \u003cp\u003eOverall, the aim is to improve body awareness to reduce vulvar pain and psychological distress and improve sexual function.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMaterials;\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003eParticipants\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResources: vulva.no\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eMaterials;\u003c/b\u003e\u003c/p\u003e \u003cp\u003e\u003cb\u003ePhysiotherapist\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEquipment included a treatment bench, mat, pillows, massage balls, mirror, Pilates ball and education material.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eProcedures\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInitial appointment: Assess participant \u0026ndash; take a thorough history (including previous experiences, beliefs and expectations) and clinical examination, (quality of movement, breathing pattern).\u003c/p\u003e \u003cp\u003eThe main areas of SCT include:\u003c/p\u003e \u003cp\u003e\u003cspan type=\"BoldItalic\" class=\"BoldItalic\" name=\"Emphasis\"\u003eTherapeutic alliance\u003c/span\u003e is an essential component of SCT; patient and therapist are in a close working relationship, agreeing on treatment goals and home assignments. Participants take an active part in the decision-making process about their own treatment and progression.\u003c/p\u003e \u003cp\u003e\u003cspan type=\"BoldItalic\" class=\"BoldItalic\" name=\"Emphasis\"\u003eThe bodily approach\u003c/span\u003e: breathing patterns, maladaptive movement and postural patterns are addressed in various positions (sitting, standing, walking and in supine). Through manual techniques and touch participants are taught various techniques to increase body awareness, improve relaxation and reduce muscle tension.\u003c/p\u003e \u003cp\u003e\u003cspan type=\"BoldItalic\" class=\"BoldItalic\" name=\"Emphasis\"\u003eEducation\u003c/span\u003e about PVD, chronic pain, stress and healthy vulvo\u0026ndash;vaginal and sexual behaviors.\u003c/p\u003e \u003cp\u003e\u003cspan type=\"BoldItalic\" class=\"BoldItalic\" name=\"Emphasis\"\u003eCoping\u003c/span\u003e with emotions and thoughts related to bodily experiences. Participant learns to become aware of negative/catastrophizing thoughts and learns how to restructure or accept these thoughts as well as how to overcome fear avoidance behavior. An important aspect is the women\u0026rsquo;s ability to adapt and to self-manage their condition such as coping with pain and flare-ups.\u003c/p\u003e \u003cp\u003e\u003cspan type=\"BoldItalic\" class=\"BoldItalic\" name=\"Emphasis\"\u003eStructured homework\u003c/span\u003e promoting the application of learned techniques in daily situations. Gradual exposure to activities associated with pain, desensitization exercises and exercises to increase pelvic floor and vulva awareness. Relaxation and breathing exercises.\u003c/p\u003e \u003cp\u003eLast session \u0026ndash; create a self-management toolbox with participant\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWho provides\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eExperienced female physiotherapist trained in SCT, first author of article.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHow\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEach session has a three phased structure: 1) The conversation, 2) the bodily intervention/exploration and 3) the home assignment.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWhere\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIn a closed room with access to gym, outpatient physiotherapy clinic, Oslo Metropolitan University, Norway\u003c/p\u003e \u003cp\u003eHome assignments performed by the participants integrated into ADL\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eWhen and how much\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInitial appointment offered to patients after collection of baseline data\u003c/p\u003e \u003cp\u003eMedian number of sessions: 12 (min 7; max 15) face to face with physiotherapist,\u003c/p\u003e \u003cp\u003eTreatment period: minimum 13 weeks and maximum 22 weeks\u003c/p\u003e \u003cp\u003eEach session (including initial session), lasted up to 60 minutes.\u003c/p\u003e \u003cp\u003eThe number of sessions required was personalized.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTailoring\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eThe treatment is personalized and tailored to the individual. Patient participation and collaboration is important. The treatment principles are the same for all but are adapted to suit the individual\u0026rsquo;s needs.\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section3\"\u003e \u003ch2\u003eStudy outcomes\u003c/h2\u003e \u003cdiv id=\"Sec12\" class=\"Section4\"\u003e \u003ch2\u003ePrimary feasibility outcomes\u003c/h2\u003e \u003cp\u003eThe primary aim of this study was to evaluate the feasibility of undertaking a full-scale RCT of SCT for women with PVD. This trial measured several feasibility outcomes in preparation for the main trial. These included:\u003c/p\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eRecruitment rate\u003c/b\u003e. This was defined as the number of eligible patients and number of recruited participants per week within a period of five months.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eThe follow-up response rate\u003c/b\u003e. This was measured by the percentage of participants who were followed up successfully until the eight months follow-up.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eAdherence to completion of outcomes\u003c/b\u003e. Adherence was defined as the number of participants who fully completed the battery of self-reported questionnaires, the 14-day diary, the number of performed tampon tests and biweekly forms about the received treatment, within a time frame of eight months.\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eEvaluation of the utility value of the tampon test\u003c/b\u003e as a primary outcome measure based on tampon test data and the participant\u0026rsquo;s experiences with the tampon test (reported in separate mixed methods study (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e).\u003c/p\u003e \u003c/li\u003e \u003cli\u003e \u003cp\u003e \u003cb\u003eReporting of adverse events\u003c/b\u003e. An event was recorded as adverse if a participant was pulled out of the study because SCT was deemed as an inappropriate treatment.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section3\"\u003e \u003ch2\u003eSecondary outcomes\u003c/h2\u003e \u003cp\u003eThe secondary aim of this study was to test the implementation and acceptability of the somatocognitive intervention utilising both quantitative and qualitative data. The 6-point Global Perceived Effect (GPE) scale was used to provide quantitative estimation of participants' perceived effect with the treatment directly after treatment and at the eight months follow-up (\u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e). The participants were asked \u0026ldquo;Overall, how much did the treatment you received help your problems?\u0026rdquo;. The scale ranges from one to six; very much better, much better, a little better, no change, much worse and very much worse. During the semi-structured interviews, participants were asked about their experiences with SCT intervention, both towards the end of the treatment period and one year later. In addition, the aim was to evaluate if SCT has the potential to reduce pain, pain catastrophizing and psychological distress, as well as the potential to improve sexual function. A description of the self-reported outcome measures is provided in additional file 2.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eFor the feasibility analysis, the results will be expressed as numbers referring to recruitment rate, follow-up, adherence and adverse events respectively. Descriptive statistics were used to assess the feasibility objectives and the self-reported outcomes using SPSS (version 27, IBM, Armonk, NY, United States of America) and Microsoft Excel (2016). Due to the nature of a feasibility study and the low number of participants, no hypothesis testing was performed, hence the continuous variables were presented with median and quartile values.\u003c/p\u003e \u003cp\u003eIn the qualitative phase a semantic thematic analysis was performed by the interviewer (\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e). Attentive reading and re-reading of the transcripts helped to discern central aspects in the women\u0026rsquo;s experiences and initial codes were identified. Taking care to include both common and diverging experiences, these initial codes were then reworked and organized into a map of themes and sub-themes related to experiences with outcome measures, the somatocognitive intervention and perceived benefits (included in additional file 3) The first and second author independently reviewed and revised the map for validity against the dataset until agreement between the authors was reached. The findings are presented as analytical summaries and illustrative quotes, which are fitted under relevant subheadings in the \u003cspan refid=\"Sec15\" class=\"InternalRef\"\u003eresults\u003c/span\u003e section. All co-authors took part in the discussion of the final findings.\u003c/p\u003e \u003c/div\u003e "},{"header":"Results","content":" \u003cp\u003eTen nulliparous women with PVD, median age 21 (18 to 33), participated in this feasibility study. The sociodemographic and clinical characteristics of the participants are presented in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Seven of the women reported different comorbidities including jaw pain, muscle pain and twitching, anal pain, endometriosis, headache, migraine, fibromyalgia, irritable bowel syndrome and alopecia areata. Overall, the women were physically active, exercising from one to three times per week for 30\u0026ndash;60 minutes at moderate to high intensity levels. Only one reported never exercising. At baseline, four subjects were on oral contraceptives; one on cerazette, one on marvelon and two on oralcon. In terms of concurrent drug use all participants reported to have tried topical lidocaine. At baseline, six patients used topical lidocaine on a weekly to daily basis. In addition, one participant was on systemic treatment with amitriptyline, another on levothyroxine and one on diclofenac.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eSociodemographic and clinical characteristics of ten women with provoked vestibulodynia\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristics\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eParticipants\u003c/p\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;10\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge \u003cem\u003e(yrs.)\u003c/em\u003e, median (Q1; Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21 (20; 26)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePain duration \u003cem\u003e(yrs.)\u003c/em\u003e, median (Q1; Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (3; 8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary PVD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRelationship category\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMarried/common law\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIn a relationship\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSingle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChildbirth\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntercourse past 4 weeks\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEducation category\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eHigh school student\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUndergraduate student\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCompleted bachelor's degree\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWork category\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStudent\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePart time work\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFull time work\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUnemployed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipants with comorbidities\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI, median (Q1; Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23 (20; 23)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eResults of feasibility outcomes\u003c/b\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eRecruitment rate\u003c/b\u003e \u003c/p\u003e \u003cp\u003eEighteen women were found eligible for participation, and ten women contacted the primary investigator and agreed to take part in the study. Ten participants were recruited over 11 weeks from the Vulva Clinic, achieving a recruitment rate of 0.9 participants per week. Recruitment was stopped when the targeted sample of ten participants was reached.\u003c/p\u003e \u003cp\u003e \u003cb\u003eFollow-up rate\u003c/b\u003e \u003c/p\u003e \u003cp\u003eNo participants were lost to follow-up. All the participants completed the SCT intervention and all partook at all measurement time points up until the eight months follow-up.\u003c/p\u003e \u003cp\u003e \u003cb\u003eAdherence to assessment procedures\u003c/b\u003e \u003c/p\u003e \u003cp\u003eOverall adherence to the battery of self-report questionnaires was excellent, with all participants completing all the self-reported questionnaires at all three time points. In terms of adherence to the tampon tests across the three measurement time points, 81 out of 90 tampon tests were completed (90%). At baseline, there were nine full tampon test sets. Post treatment there were eight full tampon test sets and at the eight months follow-up there were six full tampon test sets. For the 14-day diary there were six full data sets at baseline, three post-treatment and two at the eight months follow-up. Regarding adherence to the bi-weekly forms about received treatments, two women did not record any of the SCT treatments, however all the other treatments received were recorded.\u003c/p\u003e \u003cp\u003e \u003cb\u003eEvaluation of the tampon test as the primary outcome measure\u003c/b\u003e \u003c/p\u003e \u003cp\u003eEvaluation of the tampon test is reported in a separate paper (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e). We concluded that the test may be suboptimal as a primary outcome measure in PVD research. The tampon test data demonstrated large intra- and inter-individual variability, furthermore the test seems to underestimate severity of pain in some women with PVD. Out of ten women with PVD, four of the women had an NRS score that was equal to, or below four, whilst concurrently reporting high levels of pain during sexual intercourse. Participants with low pain scores would be excluded from studies where the tampon test is part of the trial eligibility criteria, even though severe pain was experienced during sexual intercourse. Several women also reported in the interviews that they experienced the test as an inadequate measure of their problem (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cb\u003eReporting of adverse events\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThere were no adverse events reported, i.e. no participants were pulled out of the study because SCT was considered as an inappropriate treatment. All participants turned up for their scheduled appointments and completed the intervention.\u003c/p\u003e \u003cp\u003e \u003cb\u003eResults of secondary outcomes\u003c/b\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eImplementation and acceptability of somatocognitive therapy\u003c/b\u003e \u003c/p\u003e \u003cp\u003eIn this study the participants received a median number of 12 sessions. The SCT was personalized, hence the number of treatments delivered varied from seven up to a maximum of 15 sessions. In the original protocol, we stipulated that treatment duration would last for up to ten weeks. In this study, the treatment course lasted a minimum of 13 weeks and a maximum of 22 weeks. The frequency of the treatment delivery varied as it was personalized to the individual\u0026rsquo;s needs. Patients communicated to the therapist that they needed time to practice home assignments and incorporate what they had learnt into their ADL. Frequency of treatment was also influenced by external factors such as study and work commitments, exams, and holidays.\u003c/p\u003e \u003cp\u003eHalf of the participants were content with the number of treatment sessions received and felt ready to continue by themselves when the treatment period ended. The other half reported that they would have preferred a slightly longer treatment period. Several found it more difficult to keep motivated to prioritize their recovery process when their progress was no longer monitored by the therapist. \u003cem\u003eP8: \u0026ldquo;Immediately after the treatment period ended it felt a bit tough. You receive such close guidance, and then you are suddenly alone with it again. I found it a bit difficult to keep my motivation up\u0026rdquo;.\u003c/em\u003e Most felt they would have benefited from one or two follow-up sessions a few months later, for repetition, motivation and guidance on how to move forward. \u003cem\u003eP3: \u0026ldquo;Perhaps it could have been possible with a follow-up session six months later, in case things should get worse or you need some repetition, or when things have just been a little too much.\u0026rdquo;\u003c/em\u003e\u003c/p\u003e \u003cp\u003e \u003cb\u003eParticipants\u0026rsquo; perceived effect of SCT\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThe GPE scale was used to provide quantitative estimation of participants\u0026rsquo; perceived effect of the treatment measured directly after treatment and at eight months follow-up. Directly after treatment three women reported to be \u003cem\u003every much better\u003c/em\u003e, four reported to be \u003cem\u003emuch better\u003c/em\u003e and three reported \u003cem\u003ea little better\u003c/em\u003e. At eight months follow-up one participant reported to be \u003cem\u003every much better\u003c/em\u003e, six participants reported \u003cem\u003emuch better\u003c/em\u003e, two reported \u003cem\u003ea little better\u003c/em\u003e and one reported \u003cem\u003eno change\u003c/em\u003e.\u003c/p\u003e \u003cp\u003e \u003cb\u003eParticipants\u0026rsquo; experiences with the intervention\u003c/b\u003e \u003c/p\u003e \u003cp\u003eAll participants expressed positive experiences with the SCT approach. They found it useful to learn techniques for deep breathing, relaxation, and self-management, as well as developing more constructive ways of thinking about and relating to their pain and sexuality. The participants largely expressed beliefs that PVD is complex and multidimensional in nature. They found it meaningful to combine physical and psychological aspects, and not exclusively focus on the painful vulvar area. \u003cem\u003eP3: \u0026ldquo;I feel that somatocognitive therapy is more focused on the long-term recovery process. That it is easier to get lasting results when you not only treat the local muscles or problem area, but also include everything else around\u0026rdquo;.\u003c/em\u003e Furthermore, the importance of taking responsibility for their own recovery process was expressed by P6: \u003cem\u003e\u0026ldquo;It makes so much sense that this is what I have to do. Not just talk about it and not just receive massage here or there. I have to make an active effort. Breathe. I have to relax\u0026rdquo;.\u003c/em\u003e Three participants however (P2, P7 and P9), felt the intervention would have benefitted from a specific focus on the vulvar area, including manual techniques to release tensions in the pelvic floor muscles. Most of the participants however, appreciated the gentle and desensitizing approach to the vulva. Several women also expressed that the encouragement to explore their own vulvas had helped them develop a more positive way of relating to this area. \u003cem\u003eP4: I feel like I have made great improvements as before my vulva felt very unfamiliar, I just didn\u0026acute;t want to think about it. But now I actually feel that I have developed a completely different way of thinking about it and how it also is about being less afraid of the area\u0026rdquo;.\u003c/em\u003e\u003c/p\u003e \u003cp\u003eThe secondary aim of this study was to evaluate if SCT intervention had the potential to improve sexual function and reduce pain, pain catastrophizing and psychological distress. The women improved on all the outcome measures from baseline to post treatment, with a slight deterioration of the effect at the eight months follow-up. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e includes all the measurements and number of participants who had experienced intercourse in the past four weeks, at the three time points.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eMeasurements at baseline, post-treatment and 8 months follow-up (n\u0026thinsp;=\u0026thinsp;10), (none lost to follow-up)\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePre-treatment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePost-treatment\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003e8 months follow-up\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTampon test\u003c/b\u003e NRS (0\u0026ndash;10), median (Q1; Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.5 (2.5; 6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2 (1.5; 4.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.5 (1.8; 4.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntercourse past 4 weeks, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eFSFI\u003c/b\u003e, median (Q1; Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal sum (0\u0026ndash;36)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14.8 (9.8; 19.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22.8 (15.8; 25.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e20.9 (18; 27.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDesire\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.1 (1.6; 3.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.6 (2.3; 3.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.6 (2.7; 4.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eArousal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.2 (1.6; 4.9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.4 (2.7; 5.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.4 (3.0; 5.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLubrication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4.2 (2.9; 5.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.8 (3.5; 5.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.7 (3.6; 6.0)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOrgasm\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3.2 (0.9; 5.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.8 (2.6; 5.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e4.8 (1.2; 5.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSatisfaction\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.8 (0.4; 2.0)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4.2 (1.1; 5.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3.8 (1.2; 5.3)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePain\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0.0 (0.0; 0.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.8 (0.0; 3.6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.0 (0.0; 3.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003ePCS (0\u0026ndash;52)\u003c/b\u003e, median (Q1; Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20 (15.3; 29.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e9.5 (5.3; 20)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e12.5 (6.3; 22)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHSCL-25\u003c/b\u003e, median (Q1; Q3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2.0 (1.7; 2.5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.6 (1.3; 2.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1.8 (1.6; 2.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eNRS: Numerical Rating Scale; (higher scores indicate more pain) FSFI: Female Sexual Function Index (higher scores indicate better sexual function); PCS: Pain Catastrophizing Scale (higher scores indicate higher levels of catastrophizing; HSCL-25: Hopkins Symptom Check List \u0026minus;\u0026thinsp;25 (higher scores indicate higher levels of psychological distress).\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e "},{"header":"Discussion","content":" \u003cp\u003eThis study was designed to assess the feasibility of running a full-scale RCT of the SCT intervention for women with PVD. In addition, the implementation and acceptability of SCT was evaluated, including its potential as a treatment for PVD. The current study demonstrated that the study was feasible with respect to follow-up rate and adherence to the assessment outcomes. We would argue that the intervention was acceptable based on Global Perceived Effect scores, the participants\u0026rsquo; experiences with the intervention and the changes seen on the outcome measures. No adverse effects were reported. Based on the feasibility findings a few changes are suggested to optimize the protocol. In the following section the feasibility outcomes and secondary outcomes will be interpreted and further discussed.\u003c/p\u003e \u003cp\u003eIn terms of recruitment for the study, ten out of 18 patients were recruited over 11 weeks from one site, achieving a recruitment rate of 0.9 participants per week. To run a fully powered RCT with 130 patients, recruited in approximately 24 months, we will have to expand recruitment sites to other gynecologists experienced with PVD located at various clinics in the Oslo area.\u003c/p\u003e \u003cp\u003eFeasibility outcomes related to follow-up rate and adherence was overall satisfactory. No participants were lost to follow-up and adherence to completion of the battery of self-reported questionnaires was excellent, with all ten participants fully completing the questionnaires. We demonstrated good adherence to the tampon test, with 81 out of 90 tampon tests completed (90%). Most of the missing tampon test data occurred at the eight months follow-up. The 14-day diary however, the \u003cem\u003eIndex of emotional instability\u003c/em\u003e, which was used to measure day-to-day variance in emotional states, had high levels of missing data. At the eight months follow-up there were only two complete 14-day diary sets, hence the diary will not be included in the main trial. During the interviews, many women found the diary time consuming and difficult to remember, and for some it also felt irrelevant. Adherence to the reporting of received treatment was satisfactory with eight full sets at the eight months follow-up. Two women did not record any of the physiotherapy treatments received, possibly due to a misunderstanding as all the other treatments they had received had been recorded.\u003c/p\u003e \u003cp\u003eA further aim with this study was also to evaluate the feasibility of using the tampon test as a primary outcome measure. Many women with PVD abstain from penetrative intercourse and have difficulties with reporting pain. The tampon test was therefore chosen as a primary outcome measure as it was specifically designed to address this challenge (\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e). Based on the tampon test data and the participants\u0026rsquo; experiences with the test and input from a user representative, we concluded in a separate paper (\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e) that the tampon test is suboptimal as a primary outcome measure in PVD research. Therefore, in the upcoming RCT, the primary outcome measure will be the Female Sexual Function Index (FSFI), while the tampon test will be applied as a secondary outcome. FSFI is widely used in PVD research (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e, \u003cspan citationid=\"CR49\" class=\"CitationRef\"\u003e49\u003c/span\u003e, \u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e). In addition to pain experienced during intercourse, it captures several other dimensions of sexual functioning. In this study the participants improved on average by 7.9 points (from 14.8 to 22.7 post treatment) and 6.1 points (from 14.8 to 20.9) at the eight months follow-up, when accounting for all subscales on the FSFI. We observed very similar magnitude of changes on all subscales, which conforms to the notion of a multidimensional nature of this disorder. In preparation for the upcoming main trial, the choice and implementation of outcome measures, including the FSFI, will be based on the findings from this feasibility study and \u003cem\u003eRecommendations for the study of the vulvar pain in women, part I: review of assessment tools\u003c/em\u003e (\u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eOverall, we would argue that SCT is an acceptable and promising intervention. These findings are in line with previous studies evaluating the effect of SCT for women with chronic pelvic pain (\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) and women with PVD (\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e). SCT is designed as a short-term therapy where one of the goals is to promote self-management of PVD and avoid over-treatment and therapist-dependency. Although approximately half the women were satisfied with the amount of treatment received, some expressed that the treatment ended too soon and described how a booster session would be valuable. This would provide an opportunity to receive support and guidance over time. Consequently in the future RCT, the participants will be offered one booster-session six months after the end of the treatment.\u003c/p\u003e \u003cp\u003eParticipants perceived effect was measured with the GPE and was further supported by the qualitative interviews with most women reporting a variety of improvements following the SCT intervention. In terms of pain reduction, most women described a recovery process characterized by periods of improvements and setbacks, but overall experienced a positive development. Meaningful changes also included improved body awareness; an improved ability to relax, feel more connected and comfortable in their own bodies. Several of the participants also described how the intervention had helped them develop a more neutral and less fearful way of thinking about their pain, which was also supported by the findings on the pain catastrophizing scale. Furthermore, the women had gained more healthy attitudes and strategies regarding their sexuality and some felt more confident involving their romantic partner in the recovery process.\u003c/p\u003e \u003cp\u003eThis study allows us tentatively to assess the effectiveness of the intervention in a small sample of participants. This study was not powered to detect changes over time and results should therefore be interpreted with caution. Albeit, all outcome measures pointed in the same direction, as the participants improved on the primary outcome, i.e. the tampon test, and all the secondary outcomes in the main questionnaire packet following SCT. The results indicate that the intervention has potential treatment effectiveness in a small sample of participants with PVD.\u003c/p\u003e \u003cp\u003eLimitations of this study were the small sample and the lack of an active control group. In the main trial the SCT will be compared to standard treatment. A control group could have provided us with valuable information about the treatments delivered in this group, as well as the feasibility of the randomization process. The strength of this study is that both quantitative and qualitative methods were implemented to evaluate the feasibility and acceptability of SCT.\u003c/p\u003e "},{"header":"Conclusion","content":" \u003cp\u003eWe conclude that it is feasible and practical to deliver a RCT of SCT, a multimodal physiotherapy intervention, in women with PVD. The aims of the feasibility study have been met, however some changes are suggested to optimize the study protocol, before conducting a full-scale RCT. This includes replacing the tampon test with the FSFI, increasing the recruitment sites and adding a booster session.\u003c/p\u003e "},{"header":"Abbreviations","content":"\u003cp\u003eFSFI: Female Sexual Function Index; HSCL-25: Hopkins Symptom Check List \u0026ndash; 25; NRS: Numeric Rating Scale; PCS:\u0026nbsp; \u0026nbsp; \u0026nbsp;Pain Catastrophizing Scale; PVD: Provoked Vestibulodynia; RCT: Randomized Clinical Trial; SCT: Somatocognitive Therapy\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u003c/strong\u003e The Regional Committee for Medical Research Ethics in South East Norway (ref. no.\u0026nbsp;2018/1036) approved the project before the trial began. All patients gave their written informed consent after being provided verbal and written information. The trial adheres to the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eConsent to publish results were obtained from all participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and material:\u003c/strong\u003e Anonymised individual-patient datasets are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u0026nbsp;\u003c/strong\u003eThe authors declare that they have no competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e Funding from Oslo Metropolitan University and the Norwegian Fund for Post-Graduate Training in Physiotherapy. The funding bodies had no role in the design of the study and collection, analysis and interpretation of data or in the writing of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eGKH, ALOH and SW\u0026nbsp;conceptualized and designed the study. Acquisition of data was performed by MBK, KGD, ALOH and SW. MBK and KGD analyzed and interpreted the data. MBK drafted the manuscript, and KGD, GKH, ALOH and SW revised the manuscript for intellectual content. All authors read and approved the final manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank all the patients who participated in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor details\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003csup\u003e1\u003c/sup\u003e\u003c/strong\u003eDepartment of Physiotherapy, Oslo Metropolitan University, Oslo, Norway; \u003cstrong\u003e\u003csup\u003e2\u003c/sup\u003e\u003c/strong\u003eAcute Psychiatric Department, Oslo University Hospital, Oslo, Norway; \u003cstrong\u003e\u003csup\u003e3\u003c/sup\u003e\u003c/strong\u003eDepartment of Obstetrics and Gynecology, Oslo University Hospital, Oslo, Norway; \u003cstrong\u003e\u003csup\u003e4\u003c/sup\u003e\u003c/strong\u003eDepartment of Dermatology, Oslo University Hospital, Oslo Norway; \u003cstrong\u003e\u003csup\u003e5\u003c/sup\u003e\u003c/strong\u003eDepartment of Neurology, Oslo University Hospital, Oslo Norway.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHarlow BL, Kunitz CG, Nguyen RH, Rydell SA, Turner RM, MacLehose RF. 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Treating gynaecological pain: the experiences of bachelor students in physiotherapy performing somatocognitive therapy. Physiother Theory Pract. 2015;31(5):318\u0026ndash;26.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChisari C, Monajemi MB, Scott W, Moss-Morris R, McCracken LM. Psychosocial factors associated with pain and sexual function in women with Vulvodynia: A systematic review. Eur J Pain. 2021;25(1):39\u0026ndash;50.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFoster DC, Kotok MB, Huang LS, Watts A, Oakes D, Howard FM, et al. The tampon test for vulvodynia treatment outcomes research: reliability, construct validity, and responsiveness. Obstet Gynecol. 2009;113(4):825\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStockdale CK, Lawson HW. 2013 Vulvodynia Guideline Update. J Low Genit Tract Dis. 2014;18:93\u0026ndash;100.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eEldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ (Clinical research ed). 2016;355.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, et al. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191\u0026ndash;208.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFernandes L, Storheim K, Lochting I, Grotle M. Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain. BMC Musculoskelet Disord. 2012;13:111.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDerogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974;19(1):1\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRost S, Van Ryckeghem DML, Koval P, S\u0026uuml;tterlin S, V\u0026ouml;gele C, Crombez G. Affective instability in patients with chronic pain: a diary approach. Pain. 2016;157(8):1783\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePukall CF, Bergeron S, Brown C, Bachmann G, Wesselmann U, Group VCR. Recommendations for Self-Report Outcome Measures in Vulvodynia Clinical Trials. Clin J Pain. 2017;33(8):756\u0026ndash;65.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDe Andres J, Sanchis-Lopez N, Asensio-Samper JM, Fabregat-Cid G, Dolz VM. Peripheral subcutaneous vulvar stimulation in the management of severe and refractory vulvodynia. 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Obstet Gynecol. 2010;116(3):583\u0026ndash;93.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGuillet AD, Cirino NH, Hart KD, Leclair CM. Mindfulness-Based Group Cognitive Behavior Therapy for Provoked Localized Vulvodynia: A Randomized Controlled Trial. J Low Genit Tract Dis. 2019;23(2):170\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med. 2017;14(11):1403\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKvale S, Brinkman S. Det kvalitative forskningsintervju (Interviews: Learning the craft of research interviewing). 2nd ed. ed. Oslo: Gyldendal Akademisk; 2009.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaugstad GK, Wojniusz S, Kirschner R, Kirste U, Lilleheie I, Haugstad TS. Somatocognitive therapy of women with provoked vulvodynia: a pilot study. Scand J Pain. 2019;19(4):725\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDanielsen KG, Dahl-Michelsen T, Hakonsen E, Haugstad GK. Recovering from provoked vestibulodynia: Experiences from encounters with somatocognitive therapy. Physiother Theory Pract. 2018;23:1\u0026ndash;10.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHaugstad GK, Wojniusz S, Kirste UM, Kirschner RS, Lilleheie I, Haugstad TS. Pain, psychological distress and motor pattern in women with provoked vestibulodynia (PVD) \u0026ndash; symptom characteristics and therapy suggestions. Scand J Pain. 2018;18(2):221\u0026ndash;27.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKaarb\u0026oslash; MB, Danielsen KG, Haugstad GK, Helgesen ALO, Wojniusz S. The Tampon Test as a Primary Outcome Measure in Provoked Vestibulodynia: A Mixed Methods Study. J Sex Med. 2021;18(6):1083\u0026ndash;91.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010;63(7):760-6.e1.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBraun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77\u0026ndash;101.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSmith KB, Pukall CF, Chamberlain SM. 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Nord J Psychiatry. 2003;57(2):113\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"provoked vestibulodynia, vulvodynia, vestibulitis, somatocognitive therapy, feasibility study","lastPublishedDoi":"10.21203/rs.3.rs-661042/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-661042/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eProvoked vestibulodynia (PVD) is a prevalent chronic pain condition especially among young women. Pain is localized to the vulvar vestibule and is provoked by touch or pressure, such as penetrative intercourse. PVD can have profound consequences, adversely affecting a woman’s sexual life, relation to her partner and her psychological health. There is an urgent need for well-designed randomized clinical trials (RCTs) to identify the most effective interventions for this neglected women’s health condition. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eAims:\u003c/strong\u003e The primary aim of this study is to assess the feasibility of undertaking a full-scale RCT of somatocognitive therapy (SCT), a multimodal physiotherapy intervention, for women with PVD. The secondary aim is to evaluate implementation and acceptability of SCT and its potential treatment effectiveness in PVD. In the full-scale RCT SCT will be compared to standard PVD treatment.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e This multi-method feasibility study utilized a single subject study design with nested qualitative data. Ten women with PVD, aged 18-35, were recruited from the Vulva Clinic at Oslo University Hospital. The intervention took place at Oslo Metropolitan University. Participants were assessed at baseline, post-treatment and at the eight month’s follow-up with the tampon test and self-report questionnaires. The main feasibility outcomes were evaluation of recruitment rate, adherence to assessment tools and follow-up rate. The participants’ experiences with the primary outcome and the intervention were explored with semi-structured interviews. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Ten out of 18 eligible patients were recruited over 11 weeks. None were lost to follow-up. Adherence to self-report questionnaires was excellent. Adherence to tampon tests and to the reporting of treatments was good, whereas adherence to the 14-day diary was poor. No adverse events were reported.\u003cstrong\u003e \u003c/strong\u003eThe tampon test was suboptimal as a primary outcome.\u003cstrong\u003e \u003c/strong\u003eSCT was found to be an acceptable treatment based on Global Perceived Effect scores and the participants’ experiences.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: The findings suggest that it is feasible to deliver a full-scale RCT of the SCT intervention for women with PVD. Some changes are suggested to optimize the protocol, such as increasing recruitment sites, change of primary outcome measure and adding a booster session. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e: ClinicalTrials.gov NCT04208204, Registered December 23, 2019 – Retrospectively registered, \u003ca href=\"https://clinicaltrials.gov/ct2/show/NCT04208204\" rel=\"noopener noreferrer\" target=\"_blank\"\u003ehttps://clinicaltrials.gov/ct2/show/NCT04208204\u003c/a\u003e\u003c/p\u003e","manuscriptTitle":"Feasibility and Acceptability of Somatocognitive Therapy in the Management of Women with Provoked Localized Vestibulodynia - ProLoVe Feasibility Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2021-06-30 15:28:44","doi":"10.21203/rs.3.rs-661042/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2022-01-12T19:18:12+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2021-11-22T00:00:00+00:00","index":3,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2021-10-28T00:00:00+00:00","index":2,"fulltext":""},{"type":"editorInvitedReview","content":"","date":"2021-08-12T00:00:00+00:00","index":1,"fulltext":"Recommendation: Reviewer's comments unavailable pending editorial decision\n"},{"type":"editorInvitedReview","content":"","date":"2021-07-30T07:54:38+00:00","index":0,"fulltext":""},{"type":"reviewerAgreed","content":"","date":"2021-07-30T00:00:00+00:00","index":1,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2021-06-29T00:00:00+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2021-06-28T00:00:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2021-06-27T23:00:00+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2021-06-27T23:00:00+00:00","index":"","fulltext":""},{"type":"submitted","content":"Pilot and Feasibility Studies","date":"2021-06-25T15:19:20+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"pilot-and-feasibility-studies","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"pafs","sideBox":"Learn more about [Pilot and Feasibility Studies](http://pilotfeasibilitystudies.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/PAFS/default.aspx","title":"Pilot and Feasibility Studies","twitterHandle":"@MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"181ec825-6ced-4bb8-8974-f702f3036760","owner":[],"postedDate":"June 30th, 2021","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":5383469,"name":"Internal Medicine"}],"tags":[],"updatedAt":"2022-04-18T15:08:56+00:00","versionOfRecord":{"articleIdentity":"rs-661042","link":"https://doi.org/10.1186/s40814-022-01022-2","journal":{"identity":"pilot-and-feasibility-studies","isVorOnly":false,"title":"Pilot and Feasibility Studies"},"publishedOn":"2022-03-23 15:08:56","publishedOnDateReadable":"March 23rd, 2022"},"versionCreatedAt":"2021-06-30 15:28:44","video":"","vorDoi":"10.1186/s40814-022-01022-2","vorDoiUrl":"https://doi.org/10.1186/s40814-022-01022-2","workflowStages":[]},"version":"v1","identity":"rs-661042","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-661042","identity":"rs-661042","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}