Development, validation, adherence, self-efficiency and satisfaction of a mobile health application for women with primary dysmenorrhea.

Primary dysmenorrhea (PD) is a common gynecological condition characterized by discomfort in the abdominal region before or during menstruation, which is also often associated with symptoms of fatigue, dizziness, headache, diarrhea, nausea, and vomiting ( 1 ). PD is a gynecological condition with a prevalence ranging from 49% to 75% in adolescents ( 2 ) and from 45% to 95% in the adult female population worldwide ( 3 ). It is believed that the pathophysiology of PD is related to increased production of prostaglandins after the decrease in progesterone levels at the end of the luteal phase, causing frequent dysrhythmic uterine contractions and generating pain due to tissue ischemia and hypoxia ( 3 ). The pain is localized in the suprapubic region and occurs a few hours before or after the menstruation onset ( 4 ) and, when recurrent, can generate systemic effects associated with central sensitization ( 5 ). In approximately 50% of cases, there is an association between PD and premenstrual syndrome, which is characterized by tension and fatigue ( 6 ), but symptoms related to irritability, depression and anxiety may also occur ( 7 ). Associated with these symptoms, PD pain can generate functional disability ( 8 ), absenteeism and presenteeism at school and at work ( 9 ), factors that negatively affect women’s quality of life ( 10 ). Although it has a high prevalence and impact on quality of life, PD is not recognized as a health problem by women, doctors, and society ( 11 ). Despite acknowledging all the symptoms associated with PD, many women consider this problem “natural” or “part of life” ( 11 ). In addition, it is estimated that women with PD go eight times more often to medical appointments and have two to three times higher healthcare costs than women without PD complaints ( 12 ). Health education is a therapeutic intervention adopted and effective in several clinical conditions of women’s health ( 13 ) and can also help women with PD have a better quality of life and, consequently, reduce the financial and academic burden on the health system ( 3 ). Studies indicate that evidence-based health education programs improve self-management behaviors of women with PD ( 14 , 15 ), making them effective in promoting the health of these individuals ( 16 ). Therefore, adopting educational materials in the treatment of PD can contribute to improving the health of symptomatic women. Thus, information and communication technologies (ICT), such as applications (apps) for mobile devices, can contribute to monitoring and health care, facilitating access to information and with a good cost-benefit for users of health services ( 17 , 18 ). A systematic review surveyed the mobile health (mHealth) app on the menstrual cycle available on the Google Play Store and AppStore platforms in Brazil and concluded that the available apps are of moderate quality, limited functionality and are not aimed at self-management of PD ( 19 ). This demonstrates the existence of a gap in apps that can help with self-management of PD symptoms, despite a large portion of the world’s population has access to mobile devices, the internet, and health-related apps ( 20 ). Making it necessary to develop and validate health apps aimed at knowledge and self-management of dysmenorrhea. Thus, this study aims to develop a prototype mHealth app for managing pain and symptoms associated with PD and validate its content, and to evaluate adherence, self-efficacy and satisfaction of women with dysmenorrhea with this app.

This is a descriptive study in the technological production modality that was carried out at the Physical Therapy Department, Federal University of São Carlos (UFSCar), between October 2021 and March 2023. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by Ethics and Research Committee of Federal University of São Carlos (CAAE. 54768621.3.0000.5504). All participants agreed to participate and provided their informed consent in electronic format. The creation of the ColicApp mHealth app consisted of the following steps: (I) bibliographic review and language adequacy; (II) app prototype development; (III) content validation by health professionals and women with PD; and (IV) assessment of adherence, self-efficacy, and satisfaction with the educational content available on ColicApp. The content inserted in the app was selected through a literature search, with the aim of including scientific evidence on PD self-management. A search strategy was performed in the PubMed database using the Medical Subject Headings (MeSH) tool combined by the Boolean operators AND, OR, and NOT: dysmenorrhea; health education; mobile apps; self-efficacy; women’s health; physiotherapy. The eligibility criteria for inclusion of the studies include having comprised content on anatomy, physiology of dysmenorrhea, and pain management ( Figure 1 ). The language of the information included in the app was adapted to make it accessible to the target audience. A group of 10 women from the community evaluated the content produced by the researchers and suggested the necessary adaptations for the population’s understanding and comprehension. Flowchart of study selection. The development of the mHealth app “ColicApp” followed the steps described by Saboia et al. [2019] ( 21 ): App modeling—formation of a conceptual model about the problem and content definition; Prototype development—determination of menus, indexes and scripts in order to facilitate the use of the application by individuals with different educational levels; and Implementation of the project—creation of sounds, images, animations and videos and transferred to the computer, linked to the Android ® operating system (Google, United States). The ColicApp content was divided into 7 sections: definition and prevalence of dysmenorrhea; types of dysmenorrhea; menstrual cycle and hormonal changes; pathophysiology of dysmenorrhea; symptoms associated with dysmenorrhea; self-care; pain management (application of local heat, self-massage, and physical exercise, as well as specifying the frequency, location, time and care required with these types of management). The app was developed and hosted on the Wix website ( https://pt.wix.com ) ( Figure 2 ). The layout of the developed multimedia app prototype (available online: https://cdn.amegroups.cn/static/public/mhealth-24-88-1.pdf ). Women’s health physiotherapist and women with self-reported PD evaluated the application’s content, relevance, and interface. Recruitment was carried out through advertisements on social networks, such as Facebook ® and Instagram ® , in addition to referrals by other professionals, using the Snowball technique ( 22 ). Brazilian physiotherapists with at least one year of experience in women’s health were included. Brazilian women (age equal to or greater than 18 years) with self-reported PD in the last three months and who owned a smartphone (Android or iOS) with internet access were included. Women with a medical diagnosis of secondary dysmenorrhea (e.g., endometriosis, polycystic ovary, uterine myoma, among others) were excluded. For the validation of the application by health professionals, the Evaluation of Printed Education Materials (EVALPEM) was adopted, an adapted and specific instrument to assess the competences and importance of the content of this application ( 23 ). The questionnaire was inserted into Google Forms and evaluated the following criteria: scientific basis, content, literary presentation, illustrations, understanding and scope of the material, quality of information and download, presentation and functioning. The response options were based on the Likert scale: 1, strongly disagree; 2, disagree; 3, neither agree nor disagree; 4, agree; 5, strongly agree ( 24 ). In addition, suggestions could be provided in a blank field at the end of the questionnaire. After the adaptations made to the app according to the assessment of health professionals, women with PD evaluated the ColicApp by one instrument adapted for assessing skills and assessing the importance and understanding of the content inserted in the app ( 25 , 26 ). The following criteria were evaluated: functionality, content, language, illustrations, design, innovation, and satisfaction with the application. Possible answers were also based on the Likert scale (Likert, 1932), which includes: 1, strongly disagree; 2, disagree; 3, neither agree nor disagree; 4, agree; 5, strongly agree. Suggestions could also be inserted at the end of the questionnaire. Women of reproductive age (equal to or over 18 years), with self-report of PD in the last three months, and who had a smartphone with internet access were included. To characterize the participants, a questionnaire prepared by the researchers was used to collect sociodemographic, clinical, and gynecological information. The participants also responded for three menstrual cycles in a row about the average intensity of pain using the 10-point Numeric Rating Scale (NRS), with response options from zero “no pain” to 10 “the worst possible AUC pain”. The NRS showed excellent criterion validity [receiver operating characteristic (ROC); area under the curve (AUC) = 0.90; 83% sensitivity and 86% specificity] to discriminate women with PD and excellent test-retest reliability value [intraclass correlation coefficient (ICC) =0.90] ( 27 ). Adherence was assessed using an online frequency questionnaire prepared by the researchers. The form was inserted and answered through Google Forms at each menstrual cycle, during three consecutive cycles. In the adherence questionnaire, women answered how many times they accessed the application during the last menstrual cycle. At the end of the last three registered cycles, the participants completed the self-efficacy and satisfaction questionnaires. The verification of self-efficacy aimed to assess the participants’ ability to adopt measures for pain management, suggested in the educational material. For this, the General Self-Efficacy Scale (GSE) ( 28 ) was used, a self-report instrument, Likert-type with 10 items on a scale of 1 to 5, in which the higher the score, the greater the perception of self-efficacy that the individual possesses. The satisfaction questionnaire, based on the Likert scale, included questions about download criteria, presentation and operation, pedagogical aspects, and level of satisfaction with the app in general. Both instruments were inserted and answered through the Google Forms platform. For the content validation analysis of the app, the content validity index (CVI) was used ( 29 ). The CVI is one of the main methods used in the health area for content validation, making it possible to verify the proportion of agreement of each item of the booklet evaluation instrument between the health professionals ( 29 ). For the calculation, The Likert scale was used, in which the index score is calculated by adding the agreement of the items that were marked. The sum of the CVI was used separately and then the value was divided by the number of items in the instrument. A cutoff greater than 0.80 was considered adequate ( 30 ). The percentage of agreement between professionals and women with PD was also calculated, consisting of the sum of positive responses divided by the total number of evaluations performed. The minimum level of consensus of 75% was considered adequate ( 31 ). The other data were presented descriptively, using mean and standard deviation or absolute and relative frequency. Spearman’s correlation coefficient was used to verify the correlation between adherence to each cycle (dichotomous variable) and pain (continuous variable). All analyzes were performed using SPSS 22 (Chicago, IL, USA) and a significance level of 5% was adopted.

The evaluation of the app’s content was carried out by 22 health professionals, with at least 1 year of experience in Women’s Health, of which 56.5% specialized in women’s health. The app’s content was evaluated by 17 Brazilian women with PD, whose professions were: student, saleswoman, clerk, administrative assistant, pedagogue, and housewife. Sociodemographic data are described in Table 1 . PD, primary dysmenorrhea. Table 2 presents the agreement responses and the professional’s CVI for each App Evaluation item. It is observed that CVI is greater than 0.76 and the total level of agreement between professionals is 96%. The results show the CVI of the target audience, women with PD, that most of the criteria presented CVI values above the standard cutoff point in the literature of 0.80 and a total agreement level among women of 94% ( Table 3 ). CVI, content validity index. CVI, content validity index; PD, primary dysmenorrhea. For women who evaluated the application, a section was also left on the form so that participants could express their opinion on improving the content and possible improvements that could be made. The following suggestions were indicated: I think there should be explanatory videos for women who have low reading, so that they can easily find out about the subject; “Very easy and concise, I found it very easy for the reader to understand the target subject, congratulations to the developers.” Ninety-nine women with PD symptoms participated in assessing adherence, self-efficacy, and satisfaction with using the application. Most participants lived in the southeast region of Brazil (64.6%), aged between 18 and 29 years (61.3%) and had higher education (64.6%). Table 4 presents the data regarding women’s adherence, during three menstrual cycles, to the use of the ColicApp app. In the third cycle there is a reduction in mean pain, with a significant correlation (P=0.006). *, statistically significant value. SD, standard deviation. The self-efficacy results for pain management with the help of ColicApp are described in Table 5 . It is observed that all criteria evaluated by GSE obtained high percentages of approve or strongly approve. Table 5 also shows the results of satisfaction with the app, where we can see that all criteria were evaluated as strongly approved (>45%). GSE, General Self-Efficacy Scale.

As presented by Dantas et al. [2022] ( 19 ), up to the present moment there are validated, high-quality applications available in Brazil aimed at self-care in PD. Thus, this study pioneered in proposing to develop and validate an app for a health education mobile device that provides guides for self-management of pain and symptoms related to PD. In addition to the app’s development, the study also aimed to evaluate the adherence, self-efficacy, and satisfaction of women with PD when using the educational material concerning health education. However, there are international applications that demonstrate progress in developing a platform capable of assisting in the self-care of women with dysmenorrhea ( 32 ). In the study carried out by Wang and collaborators, the digital intervention carried out through the development of a smartphone application was successful in facilitating the provision of information about self-care in women with PD. The main elements to which the product’s effectiveness is attributed were scientific information based on adapted questionnaires and reminders about self-management of pain and associated symptoms ( 32 ). Although the market has mobile health applications in online stores in Brazil related to the menstrual cycle, they still have limitations, associated with the lack of evidence-based scientific information ( 19 ), and generally without relationships with academic institutions. Given this, it was relevant to create an application in Brazil that promoted health education through educational information about dysmenorrhea and assisted in the self-management of the symptoms reported by women, to facilitate the access by women affected by this pathology to this content. A study carried out in Recife/PE, with 50 schoolchildren aged between 13 and 19 years old, pointed out that 78% of the adolescents did not have knowledge regarding the menstrual period and its associations ( 33 ), evidencing low clarification on the part of them, about the menstrual cycle and possible intercurrences. This validated prototype was built with scientifically sound content, based on clinical practices, and aimed at helping with knowledge regarding menstrual disorders that are still difficult for the population to access. Thus, the use of this prototype can help in the dissemination of specific knowledge about the menstrual period for young Brazilian adolescents. Adherence is defined by the World Health Organization (WHO) as a behavioral change in the face of recommendations established by the health care provider ( 34 ), with the potential to influence the results of a clinical intervention ( 35 ) and health conditions ( 36 , 37 ). This statement can be observed in this research, which suggests that women with PD, who used ColicApp during the three menstrual cycles, have a reduction in pain after three months. Another aspect evaluated was the self-efficacy of women with PD in carrying out the recommendations suggested by the app for pain self-management. It is known that self-efficacy is the individual’s confidence in identifying their ability and performance to achieve their behavior change ( 37 ), and that it can influence the clinical evolution of patients ( 38 , 39 ). The findings of this study suggest that using a technological resource was beneficial to maintain a high self-efficacy of women who used ColicApp during the three menstrual cycles. The high adherence and self-efficacy in using the app demonstrate that the use of this educational material suggests that the ColicApp can have wide clinical applicability and be a great ally for promoting knowledge to women with PD. It should also be noted that the methodology adopted in this app and the results arising from its use contribute to improving and expanding the development of future innovative products for health education. The inclusion of properly validated apps can be applied in the care lines of different clinical conditions, promoting health and assisting in the treatment and self-management of symptoms ( 40 ). In addition, the use of widely disseminated educational materials, such as apps, can also improve the public health of a community or population affected by chronic conditions ( 41 - 43 ). A strong aspect of this study was the assessment of women’s satisfaction with ColicApp, in which the vast majority strongly reported approval in all evaluated criteria. A 2018 systematic review indicated that assessing app user satisfaction for health conditions is an important factor in identifying the functionality and efficiency of this technological resource ( 44 ). Therefore, this finding reinforces that the ColicApp can be an important instrument to assist in the self-management of PD symptoms. This project has important limitations because it has not evaluated other variables, such as secondary dysmenorrhea, which requires medical diagnosis and regular follow-up, since it presents an adjacent pelvic disease, which is not covered by the application, due to the specificity that is done, in regarding the pathology involved. In addition, the prototype presented can only be used on smartphones with internet access, limiting its use for some women. Another limitation was the lack of participation of healthcare professionals from different categories to validate the app’s content. Finally, the largest audience reached with the disclosure on social networks was women with higher education, recognizing that it is still necessary to reach an audience with low education, to reach a variety of women who suffer from PD.

The use of ColicApp, as an educational material, which provides information about PD and helps in the self-management of PD symptoms, has a high potential to reach an extensive target audience in Brazil. Our results suggest that the app is an adequate and validated technological resource for self-management of pain and symptoms. The high adherence, self-efficacy and satisfaction of the women suggest that the app may have wide clinical applicability and encourage the autonomy of women with PD. This app was developed and validated to help women to self-manage PD symptoms, but this educational technological resource can also be used by health professionals to complement protocols and therapeutic interventions. As future steps, the authors of this study intend to insert the application in the operating system stores and carry out new studies that identify the app’s performance in the operating system.

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