A comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial.

A comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial. | 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 Article A comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial. Linor Llwyd Jones, Kevin James Munro, Jane Wild This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6394074/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 18 Dec, 2025 Read the published version in Trials → Version 1 posted 6 You are reading this latest preprint version Abstract Background: Excessive earwax causes unwanted symptoms such as hearing loss, tinnitus, discomfort and changes in the quality of one’s own voice. The NHS Audiology Wax Removal Service in North Wales recommends the use of olive oil as a pretreatment wax softener administered as either drops or spray prior to microsuction. For one in four patients microsuction is unsuccessful at the first attempt. Anecdotal evidence suggests that the administration of olive oil as a spray is a more effective pretreatment. This trial aims to explore whether administering olive oil pretreatment softener is more effective when administered as drops or spray. Methods: This two-arm cluster randomised control trial will be conducted within the existing NHS Audiology wax removal service in North Wales from January to July 2025. This pragmatic trial involves 26 NHS GP practices (clusters) and compares the administration methods of olive oil pretreatment via drops and spray. A sample size of 1,742 participants (67 in each of the 26 practices) was calculated as sufficient to determine a clinically significant difference. Presumed consent is used for all eligible patients seen within the wax removal service. Patients will be advised to source and self-administer three drops or sprays of olive oil for seven days before attending a wax removal microsuction appointment with an audiology practitioner where routine anonymized data will be collected. The primary outcome is whether wax removal is successful, as assessed via visual examination. The secondary outcomes include: improvements in self-reported symptoms, the amount of residual wax following microsuction and the number of adverse events. Statistical analyses will be conducted with an intention-to-treat design to compare outcomes between the groups. Discussion: . This RCT aims to investigate whether administering olive oil as a pretreatment wax softener via drops or spray affects the outcome of wax removal. The outcome of this trial will inform future recommendations to patients and improve service effectiveness and efficiency by reducing the need for repeat visits. The results will be shared nationally and used to inform national guidance on wax removal. Trial registration: ISRCTN, ISRCTN28211073. Registered 23 December 2024, https://www.isrctn.com/ISRCTN28211073?q=earwax&filters=&sort=&offset=1&totalResults=3&page=1&pageSize=10 Earwax Wax removal Olive oil Microsuction Wax softener Cerumenolytic Figures Figure 1 Administrative information Title {1} A comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial. Trial registration {2a and 2b}. ISRCTN28211073 Protocol version {3} 20 th November 2024 Version 2.2 Funding {4} None – trial run within existing clinical service. Author details {5a} Linor Llwyd Jones, Principal Clinical Scientist, Audiology, Betsi Cadwaladr University Health Board [email protected] 03000 843864 Prof. Kevin J Munro, Ewing Professor of Audiology, The University of Manchester [email protected] 0161 275 8678 Jane Wild, Consultant Clinical Scientist, Audiology, BCUHB [email protected] 03000 843863 Name and contact information for the trial sponsor {5b} Laura Longshaw, Deputy Research & Development Manager, Betsi Cadwaladr University Health Board [email protected] 03000 856766 Role of sponsor {5c} Sponsor has the overall responsibility for ensuring that proportionate, effective arrangements are in place to set up, run and report this research study. In addition to being responsible for monitoring and audit activities, the Sponsor will advise the Chief Investigator on the study design, collection, management, analysis and report writing in accordance with our Standard Operating Procedures for Research. Introduction Background and rationale {6a} Earwax is a naturally occurring substance that is produced within the ear and forms part of the ear’s self-cleaning and protective mechanism. It achieves this by trapping dust and dirt and removing them from the ear canal, resulting in antibacterial and antifungal properties [1-6]. Earwax usually migrates out of the ear canal via natural jaw actions, such as chewing and talking, but in some cases, it can accumulate excessively, leading to occlusion within the external ear canal. This causes various unwanted symptoms, the most common being hearing loss, with other self-reported symptoms such as tinnitus, a blocked ear, changes in the quality of one’s own voice, pain or discomfort, coughing, irritation, infections and even dizziness [1,3,5,7-16]. Munro et al. [16] reported that the most common symptom of earwax was hearing loss (86.4% of patients), which affects daily living, including listening to TV and environmental awareness. Occluding earwax can also have a negative effect on a person’s quality of life by causing social withdrawal, reduced function at work, mild paranoia and disorientation [1,11,14]. The prevalence of problematic earwax is reported to be approximately 2.3 million people per year, or 5% of the general adult population, which is as high as 65% of the elderly population [1,11]. Occluding wax will only clear spontaneously in 5% of cases, which explains why earwax removal, which is the most common ENT procedure undertaken in primary care, is performed on 4 million ears per year in the UK with the goal of resolving or reducing these unwanted symptoms [1,12,17]. Rationale Despite earwax removal being a relatively common procedure, there is limited high-quality evidence on the most effective removal method. Many studies recommend the use of a wax softener prior to mechanical removal [18]. Wax softeners have been used for many years in all healthcare settings for the management of wax as a pretreatment prior to mechanical removal [2,18-20]. There are various pretreatment wax softeners available, and studies have shown no difference in the use of olive oil, water or any other wax softener [1,13,19-21]. Using a wax softener alone may lead to complete clearance of the wax in approximately 20–22% of cases, but most often, it needs to be combined with mechanical removal [13,19,22,23]. The NHS Audiology Primary Care service in North Wales offers a wax removal service located at GP practices. This is a needs-based pathway in which patients reporting symptoms consistent with excessive earwax can self-refer, or patients can be referred by professionals who confirm the presence of earwax that restricts a full view of the tympanic membrane for earwax removal. All patients are advised to use olive oil drops or spray as a pretreatment wax softener followed by attempted earwax removal via microsuction by audiology practitioners as a first-line treatment. The service evaluation data revealed that one in four patients required a return visit for a second attempt at wax removal, with the first attempt being unsuccessful due to incomplete removal of wax, as reported by the audiology practitioner. Anecdotal evidence from our practitioners suggests that administering olive oil as a spray may lead to improved success of wax removal compared with the traditional method of administering drops. This may be due to more effective coverage and contact with the wax, which is in agreement with Oron et al. [24], who reported that spray may penetrate deeper into the ear canal during application. This large-scale cluster randomised control trial aims to compare the administration methods of olive oil drops and olive oil spray as a pretreatment wax softener prior to wax removal by microsuction. No previous study has investigated whether the application of wax softeners via different methods affects the outcome of wax removal. The trial has full support from a public and patient involvement (PPI) group who has been consulted throughout the trial design and who will also be involved in the analysis and dissemination of results. PPI individuals reported this research to be valuable and important, especially within the theme and focus on preventative care and care in the community. Objectives {7} Primary objective: To compare the success of wax removal following the use of olive oil pretreatment with wax softener intervention (spray) and comparator (drops) for 7 days prior to microsuction. The success of wax removal is determined by complete clearance of wax not requiring a second visit to the clinic, as reported by the audiology practitioner upon otoscopic examination following microsuction. Secondary objectives: The secondary objective outcomes will be compared between the olive oil drop and olive oil spray groups. To explore improvements in self-reported symptoms following wax removal, a self-reported improvement scale is used. To investigate the postmicrosuction visualisation ratings (a measure of the amount of residual wax). The occurrence of adverse events associated with microsuction are monitored according to Clegg et al.[25]. Trial design {8} This RCT is a parallel, two-arm, superiority cluster randomisation trial design to compare the effectiveness of olive oil drops and olive oil spray when used as a pretreatment wax softener prior to wax removal by microsuction. A cluster randomised design was chosen to ease the organisation of the trial, as it takes place within a current clinical service, and individual randomisation would add to the workload and make the trial difficult to undertake. Twenty-six GP practices will be included and randomised via a one-to-one allocation ratio to either the intervention arm (olive oil spray) or the comparator arm (olive oil drops) prior to the start of the study. The trial is designed to have a pragmatic approach, with the data analysed via an intention-to-treat analysis. Figure 1 presents the trial flow chart. Minimal changes are introduced to the service as part of this trial but include: Verification of one of the secondary outcomes, which involves reporting the amount of residual wax following microsuction by the audiology practitioner. The amount of residual wax following microsuction is recorded by the audiology practitioner via a visual verification rating (0-3); see Table 1. A video otoscopy image will be taken with patient consent and sent to an independent professional, who will rate the amount of residual wax using the verification ratings. The ratings of the audiology practitioner and independent professional will be compared to verify the reliability of this outcome. Patients will be given a feedback slip at the end of the appointment with the audiology practitioner and asked to select which pretreatment wax softener they used. This information will be used to check adherence to the protocol when analysing the outcomes given that the pretreatment wax softener is purchased and self-administered by the patient. Methods: Participants, interventions and outcomes Study setting {9} The study will run within 26 NHS-funded GP practices that deliver the NHS Audiology Primary Care wax removal service across North Wales. The earwax removal service is delivered by audiology practitioners. Patients with symptoms, or a clinical need, can self-refer, be referred by their audiology practitioner, GP or other healthcare professional working in the practice. The research will not change service provision or routine clinical care for research participants or other patients seen within the service during the research timeline. Eligibility criteria {10} All adults over 18 years of age with the presence of earwax in one or both ears are eligible for the study. Inclusion criteria: Adults over 18 years of age Provide informed consent for microsuction Presence of wax given rise to symptoms or need that warrants removal The exclusion criteria include: Under 18 years of age Active ear infection Active dermatitis Perforated or nonintact tympanic membrane Foreign bodies present in the ear canal Any contraindication for microsuction or use of wax softeners – previous ear surgery including mastoid obliteration; grommets in situ Who will provide informed consent? {26a} Consent to participate in this trial will be presumed, as the study participants in both arms are NHS patients accessing standard NHS care, and this approach has been approved by ethics. The only difference between the two arms is that patients will be advised to use either pretreatment olive oil drops or spray rather than having a free choice of using either solution. Written consent will be obtained from a selection of patients as part of the verification of visualisation ratings for outcome verification (see Figure 1). Five patients seen by 90% of the audiology practitioners will be asked to provide consent for a video otoscopy image of their external ear canal. The CI will obtain informed consent and take video otoscope images. This image will be shared with an independent professional for outcome verification purposes. A copy of these signed and dated forms will be kept in the patient’s audiology records, and another file with trial documentation will be included in the research file. These will not be shared with anyone outside the research team. Additional consent provisions for the collection and use of participant data and biological specimens {26b} Not applicable – There are no additional consent provisions for sharing data with others in this trial. Interventions Explanation for the choice of comparators {6b} The comparator in this trial is olive oil drops, which are traditionally the most commonly used pretreatment wax softener within our wax removal service. The olive oil will be self-administered at home by the patient, or a significant other, at a recommended dose of 3 drops per ear once a day for 7 days prior to the wax removal appointment. Following feedback from the PPI individuals, advice was given from a Trial Pharmacist, who confirmed that olive oil sold for wax removal purposes in pharmacies has been through medical-grade testing rather than ordinary kitchen olive oil, so this is recommended for use as part of this trial. Intervention description {11a} The intervention in this trial is olive oil spray. Patients will be advised to use the allocated olive oil solution when booking their wax removal appointment at the GP practice. The olive oil will be self-administered at home by the patient, or a significant other, at a recommended dose of 3 sprays per ear once a day for 7 days prior to the wax removal appointment. Notably, olive oil spray has a greater cost than does the comparator. This was discussed with the PPI individuals, who deemed the price difference acceptable and unlikely to influence many participants. Criteria for discontinuing or modifying allocated interventions {11b} All patients will be encouraged to follow the pretreatment advice as part of this trial. The option to discontinue or modify the pretreatment advice will be at the discretion of the healthcare practitioner should this be clinically indicated. Strategies to improve adherence to interventions {11c} Patient information leaflets are available at participating GP practices that specifically instruct patients to administer pretreatment olive oil as per the allocation of the GP practice. The patient information leaflet highlights that the research is being carried out to investigate any differences between these two administration methods, hence the importance of adhering to the intervention. Staff reminder slips will be issued to GP practices to be placed in reception and administration offices. Additionally, staff members will be reminded regularly of the importance of encouraging patients to use the allocated solution both by the research team and the Audiology Primary Care team. Following PPI feedback regarding the occasional lack of stock of olive oil spray in community pharmacies, local community pharmacy networks have been informed of the research to encourage local pharmacies to keep stock of both drops and sprays for patients to purchase locally. Relevant concomitant care permitted or prohibited during the trial {11d} Patients may be offered concomitant care for hearing or balance assessment alongside this trial if needed. Provisions for posttrial care {30} Not applicable to this trial, as patients will only remain in the trial for the duration of one clinical visit, and there are no other deviations from normal clinical care. Outcomes {12} Primary outcome The primary outcome is a comparison of the success of wax removal across the two groups. Success of wax removal is measured by the Audiology Practitioner, who inspects the ear and calculates the proportion of patients where wax removal is successful (0 or 1 as defined in Table 1) at the first attempt and who do not need a repeat visit (2 or 3 as defined in Table 1). Secondary outcomes The secondary outcomes include the following: Improvements in self-reported symptoms (reported by patients during clinic visits prior to microsuction) measured via a 5-point improvement rating scale (much better, slightly better, about the same, slightly worse, and much worse) following wax removal in the two groups. Differences in the amount of residual wax following microsuction are measured by a postmicrosuction visualisation rating reported by the audiology practitioner through visual inspection of the ear. See Table 1. Table 1. Descriptors for visualisation ratings used postmicrosuction by audiology practitioners Visualisation rating Explanation 0 No or very minimal earwax, complete visualisation of tympanic membrane 1 Minor amount of earwax with majority of tympanic membrane visible 2 Moderate amount of earwax with only part of the tympanic membrane visible 3 Fully occluding wax, no visualisation of tympanic membrane c. Adverse events. All adverse events that occur in the clinic during or immediately after microsuction and any reported by patients up to one week after microsuction, will be recorded as per normal clinical practice. A further exploratory analysis will be completed on the following: The effect of age on the success of wax removal. Success of wax removal in patients who do not use any pretreatment. Participant timeline {13} Patients are involved in the study for wax removal. The trial requires one clinic visit for every patient. Patients will be advised to use the allocated intervention for seven days prior to their appointment and then will visit the clinic for the wax removal appointment. This is shown in the trial flow chart (see Figure 1). Sample size {14} A total sample size of 1,742 participants across 26 clusters/GP practice (67 participants in each practice) was calculated as sufficient to detect a minimal clinically important difference of 9%, with an 80% power level and 5% significance. The sample size for this trial was determined via ‘The Shiny CRT Calculator’ (accessible here: https://clusterrcts.shinyapps.io/rshinyapp/lculator: Power and Sample size for Cluster Randomised Trials (shinyapps.io)). The following parameters were used (trial design = parallel; correlation structure = exchangeable; differential clustering = false; allowance for varying cluster sizes = yes; coefficient of variation = 0.527; number of clusters per arm = 13; intracluster correlation = 0.02; ICC lower extreme = 0.01; ICC upper extreme = 0.05; outcome type = binary; proportion under control = 0.74; proportion under investigation = 0.83). The above parameters were determined via discussion with statisticians and by professional consensus. A consensus was reached among 13 professionals regarding the minimal clinically important difference in the use of a specified pretreatment wax softener. The majority of the responses from the 13 professionals were between 6% and 10%, so for a conservative approach, we decided to use 9%, which was also the average. The NHS Audiology wax removal service in North Wales is still in the process of roll out, and the actual number of GP practices participating in the study may be greater than 26. If this is the case, the sample size calculation will be reviewed. Recruitment {15} The participants will be individual NHS patients who access the earwax removal service. They will be identified by the GP surgery administration teams or healthcare staff as per usual practice (patient contacts or is advised by healthcare professionals to request an appointment for wax removal or reporting symptoms/needs that are thought/confirmed to be because of wax build-up). The normal procedure for booking a wax removal appointment will be followed, and staff at the GP practice will be fully informed of the research. When booking the appointment, patients will be informed of the pretreatment they should use for seven days prior to their wax removal appointment by the staff member booking their appointment. Patients can book their appointment face-to-face whilst visiting the surgery or by telephone. Patients will be offered written information about using the pretreatment and will be directed to a video to watch if needed. Patients will be advised to purchase their olive oil drops or olive oil spray from a pharmacy as usual clinical care. Assignment of interventions: allocation Sequence generation {16a} Randomisation will take place at a cluster level (GP practice) with a one-to-one allocation ratio to the two groups of olive oil drops or olive oil spray via stratified block randomisation on the basis of prognostic value. Stratifying was performed on the basis of site size (small, large) with block sizes of 2 and 4. A total of 26 clusters will be randomised. Randomisation is performed via the randomisation software Sealed Envelope. Concealment mechanism {16b} The CI will implement the allocation sequence and inform each GP practice of their allocation via email and personal visits. All precautions will be taken to conceal the randomisation allocation from the audiology practitioners delivering the earwax removal service, but patients may accidentally disclose this, or practitioners may be able to identify the pretreatment product used on the basis of otoscopy findings. Throughout the research, each GP practice is identified and allocated by a unique numerical code only known by the CI. Implementation {16c} The CI will generate the allocation sequence, enroll GP practices and assign the interventions to the clusters (GP practices). As a pragmatic trial, the research is happening within normal clinical practice; therefore, patients are not officially enrolled in the study, but rather, the GP practice staff (receptionist, healthcare staff) will inform the patient of the research when booking in for the wax removal appointment. The GP practice staff will be responsible for informing the patients of the allocated intervention (olive oil drops or spray). Assignment of interventions: Blinding Who will be blinded {17a} Care providers (audiology practitioners) and the outcome verification professional will be blinded to the assignment of interventions, but we cannot accommodate patients accidentally disclosing this information during their appointment. The majority of audiology practitioners see patients from various GP surgeries at one or more locations, meaning that they are likely to see patients who have been allocated to both the comparator and the intervention during a single clinical session. Only the CI will be aware of the complete assignment of interventions, and the primary care audiology clinical leaders and GP staff members at each individual practice will be aware of their own assigned intervention. It is not possible to blind the trial participants to the assigned intervention. Procedure for unblinding if needed {17b} There is no requirement for a procedure for unblinding during this trial, as there is no risk associated with the blinding, as both interventions are the same solution only delivered in a different manner. Data collection and management Plans for assessment and collection of outcomes {18a} The trial will use routine clinical data collected from patients accessing the audiology wax removal service. No additional data are collected as part of this research, which is not routinely collected for service evaluation. No patient identifiable data are collected, and all data are recorded at the microsuction appointment visit. The premicrosuction data recorded included date, location, age, referral source and self-reported presenting symptoms. The postmicrosuction data recorded included the amount of residual wax in each ear (visualisation rating) and the degree of improvement in self-reported presenting symptoms using a 5-point scale (much better, somewhat better, no change, somewhat worse, much worse). All the data are recorded during a single clinic visit. All the data collected will be recorded on a password-protected Excel spreadsheet currently used by audiology practitioners for evaluation purposes. The spreadsheet is kept online on the Audiology Sharepoint intranet site, meaning that it is accessible to all audiology practitioners working at various NHS locations. Only patients with a complete outcome dataset were included in the final analysis. Plans to promote participant retention and complete follow-up {18b} Information about the research trial is included on the NHS audiology service’s external website and as posters in the participating GP practices to raise awareness. If patients report that they have not complied with advice and have not used a pretreatment wax softener, the audiology practitioner will continue to attempt to remove any wax via microsuction via routine service delivery. The data for these patients will be analysed separately from those for the other patients in an exploratory analysis. Data management {19} All research data will be recorded and held on a password-protected Excel spreadsheet on the internal NHS Audiology services’ online Sharepoint site, as is the current practice for service evaluation. The data will be accessible by all audiology practitioners working at the wax removal service, their service leads and the CI of the trial. There will be a focus on ensuring that the data are accurate, eligible, complete, consistent and available when needed, hence the reason for it being kept in an easily accessible location. The CI will extract the required data from the source file for analysis purposes. The data will not be shared with anyone outside the research team at any time. A numerical identification code will be allocated to the selection of patients who consent for a video otoscopy image of their ear following microsuction. This code will be added to their corresponding data input on the main spreadsheet by the CI and on their photographic consent form. The numerical code and corresponding consent form with the patient name will only be available and known by the CI. Patients will have the opportunity to share their email address to receive a summary of the trial outcomes. Their email address will not be able to be linked back to their research data entry and will be shared only with the CI. The email address will be recorded on individual GP practice patient slips alongside a GP clinic code related to the research allocation. The GP clinic codes and allocated treatment details will be stored electronically on the internal NHS Audiology online Sharepoint site in a password-protected Excel spreadsheet accessible only by the CI. This will be deleted at the end of data collection. Both the written video otoscopy consent forms and the GP practice patient slips with completed email addresses will be stored in the research file within a locked cabinet that will be accessible only by the CI. In compliance with good clinical practice (GCP), all documentation relevant to the trial will be retained for a period of 5 years following the end of the RCT. Further information on data management can be found within the protocol. Confidentiality {27} No patient identifiable information is collected as part of this research study apart from the individuals who are selected and consent to the video otoscopy verification exercise and those who volunteer to share their email address at the end of the clinic visit to be informed of the research outcome. Both the photography consent forms and completed GP practice patient slips with email addresses will be stored in the research file in a locked cabinet at the main NHS hospital site, accessible only by the CI. Any link between codes and identifiers on consent forms will be deleted at the end of data collection. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} Not applicable – no biological samples are collected or evaluated in this trial. Statistical methods Statistical methods for primary and secondary outcomes {20a} Analysis and reporting of the trial will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for cluster trials [26]. For the primary outcome analysis, a mixed effects logistic regression model will be fitted to the data with a random intercept for cluster and a fixed effect for wax softener delivery type (olive oil drops or olive oil spray) and strata (small or large GP practice). A correction factor is applied to reduce the risk of inflating the type I error rate due to the small number of clusters (<40). For the secondary outcomes investigating visualisation ratings and improvement in self-reported symptoms, we will use a linear mixed effects ordinal regression model with a random intercept for both cluster and patients and a fixed effect for wax softener delivery type (olive oil drops or olive oil spray) and strata (small or large GP practice). To investigate whether the reported improvement in self-reported symptoms/needs of patients who used olive oil drops significantly differed from that of patients who used olive oil spray, the unit of analysis is patient. To analyse whether there was a difference in the amount of residual wax measured by visualisation ratings between the olive oil drops and spray groups, the unit of analysis is the ear. The number of adverse events reported in the two groups will be analysed descriptively because of the likely low number of adverse events. Further details of the statistical analysis plan can be found within the protocol. Interim analyses {21b} The trial includes an internal pilot that involves conducting the study as planned within a sample (10%) of the GP practices. Data will be collected as per the full study, and the Red, Amber, and Green criteria will be used. If there is less than 50% compliance (red) with the protocol, data collection will stop, and urgent training visits will be arranged to ensure that patients receive appropriate advice from healthcare professionals on the use of the allocated intervention. When compliance is between 50% and 70% (amber), data collection may be paused temporarily, and GP practices may be in contact with a research reminder. If compliance is 80% (green), data collection will continue. A planned interim analysis involves verifying the visualisation ratings following microsuction. The audiology practitioner uses a numerical visualisation rating to categorise how much wax remains in the ear following microsuction attempt. To verify these ratings, an anonymised photograph of the external ear canal and ear drum will be taken via a video otoscope with individual patient consent. The image is saved via a numerical code that is related to the GP practice and the age of the patient. The image is then shared with an independent experienced professional who views the image and records an independent visualisation rating. This rating will be compared with the audiology practitioner's rating, and a Red, Amber, Green strategy (as above) will be used to validate the agreement in ratings. Methods for additional analyses (e.g., subgroup analyses) {20b} Exploratory analysis of the effect of age will be performed by rerunning the primary and secondary analyses with an additional covariate of the fixed effect of age to the multilevel model. Additionally, we expect that some patients will not adhere to the protocol and will not use any pretreatment wax softeners before attending their wax removal appointment. We will repeat the primary and secondary analyses and add a covariate fixed effect of no pretreatment used in the multilevel model. Further details can be found in the protocol. Methods in analysis to handle protocol nonadherence and any statistical methods to handle missing data {20c} A sensitivity analysis will be run by removing the patients who did not use pretreatment and rerunning the analyses of the primary and secondary outcomes. As all the data are nonidentifiable, there will be no way of identifying individual patients who have not adhered to the protocol. Only patients with a full dataset were included in the analysis. Plans to give access to the full protocol, participant-level data and statistical code {31c} Anonymized data can be made available from the authors upon reasonable request upon completion of the trial. Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} The trial is coordinated and monitored by the CI with support from the protocol contributors. The CI will have oversight and ongoing monitoring during data collection. There is no formal Trial Steering Committee or monitoring committee associated with this trial. Composition of the data monitoring committee, its role and reporting structure {21a} No data monitoring committee is required for this trial, as the trial is run within an existing clinical service for which the CI will monitor on an ongoing basis. Adverse event reporting and harms {22} Adverse events are not anticipated during this trial, as the two interventions are routinely used. Unexpected severe adverse events (SAEs) associated with the standard care intervention (ear wax removal) will be reported to the sponsor as per our Standard Operating Procedure for Safety Reporting and further assessed by the CI in addition to following standard clinical care procedures. Nonsevere adverse events will be recorded, assessed, reported and managed as per normal service delivery and departmental policy and as stated in the research protocol. Frequency and plans for auditing trial conduct {23} The trial conduct will be monitored by a sponsor-appointed monitor throughout the trial life cycle according to the sponsor risk assessment and a trial-specific monitoring plan per standard operating procedures. The study was deemed low risk; however, it may be included in routine audits conducted by the sponsor according to the sponsor audit schedule. Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} Protocol amendments will require local approval by the sponsor, ethics committee and healthcare research workers (HCRWs) before implementation. The amendment will then be shared with all participating GP practices, the audiology team delivering the wax removal service, investigators, RECs, trial registries, journals and research sponsors. Dissemination plans {31a} Trial patients have the opportunity to note their email address if they would like to hear about the trial outcomes. At the end of the trial, a summary of the research and the outcome will be shared with all patients who opt to share their email addresses. The research and outcomes will be published nationally in a peer-reviewed journal and at national/international conferences. The findings will be shared within the field of audiology and further within general healthcare networks. We are investigating ways to minimise barriers to the implementation of research findings by involving healthcare practitioners who will be providing this advice to patients in this trial (GP practice staff). Should the research show that either the intervention or comparator is more effective as a pretreatment wax softener, this information will be used to change recommendations to patients at all Wales service levels following approval from the Wales Audiology Heads of Service Group. The information will also be shared with the British Society of Audiology as new evidence for consideration to inform an update to the Aural Care (Ear Wax Removal) Practice Guidance and shared with NICE to supplement future recommendations for wax management. Discussion This research aims to answer an important question, as deemed by PPI individuals, that has the potential to impact national guidance on wax removal procedures. This pragmatic RCT runs within a current clinical service and has been designed to reflect real-life clinical practice and minimise disruption to clinical services. Audiology practitioners at any level do not currently have prescribing rights; thus, this trial is restricted by an inability to supply the olive oil solution to patients, meaning that we have adhered to the current clinical procedure in that patients source the olive oil solution themselves. This does carry a potential risk of patients not adhering to the protocol owing to product availability, issues sourcing the solution locally or failure to follow clinical recommendations. Following PPI feedback, we have attempted to minimise this by contacting community pharmacy teams across North Wales, informing them of the research and advising them to stock both olive oil drops and olive oil spray in their pharmacies for the benefit of this research and by using patient information materials and posters that highlight the importance of this research. The data will be analysed via an intention-to-treat analysis. This may mean that any difference between the two groups will be minimised, indicating that the pragmatic approach taken with the aim of better reflecting a real-life clinical situation may be seen as a strength of the trial. An alternative approach would need to be highly regulated, and any findings may not necessarily be effective in real life. Data collection is to be completed by audiology practitioners, and no additional data are being collected compared with those already being collected for data evaluation purposes. We hope this will help ensure that there are no missing data entries. All audiology practitioners involved in the service will be aware of the RCT, and its objectives and clinical leaders of the service will be involved and approved for the study design. The findings of this research will only be applicable to the use of pretreatment with the wax softener olive oil followed by the mechanical removal method of microsuction. Further research will be needed to determine whether the same findings apply to other pretreatment wax softeners or mechanical removal methods, such as irrigation. The research is run within 26 sites across North Wales. While the CI will maintain close contact with all the sites during the research, the risk remains that primary care staff booking the wax removal appointment and advising patients on the use of pretreatment wax softeners may not give the correct advice or may not emphasise the importance of adhering to recommended guidance. To help support this, each cluster site has been issued staff reminder slips that are displayed behind reception and in staff areas as reminders of the advice that should be given to patients. PPI representatives were included in the development of the study design through focus groups and email correspondence. Their input shaped the design of the protocol and methodology by validating the design and informing protocol details such as the difference between olive oil sold in pharmacies for wax removal purposes and ordinary kitchen olive oil and acceptance of price differences to patients between the investigator and comparator product. All PPI individuals approved the trial as important research and supported the ethical approval process. The PPI individuals will be kept informed of the progress of the trial as the research progresses. Trial status Protocol version 2.2 20 th November 2024. Recruitment for the study began on 1 st January 2025, and we approximate the end of data collection on 1 st July 2025. Abbreviations AE Adverse Event BCUHB Betsi Cadwaladr University Health Board CI Chief Investigator ENT Ear, Nose and Throat GCP Good clinical practice GP General Practice HCRW Health Care Research Wales NHS National Health Service PPI Patient and Public Involvement REC Research Ethics Committee R&D Research and development SAE Serious adverse event Declarations Acknowledgements The main author would like to acknowledge and thank the research team for their advice, help and support in developing this research study. We thank the BCUHB Audiology Primary Care team and GP surgeries and their staff for supporting the research. Additional thanks go to Dr Sarah Rhodes, Statistician, University of Manchester, for her statistical guidance. Authors’ contributions {31b} LLJ conceived the study and led the proposal and protocol development. KM and JW contributed to the study design, development of the proposal and protocol review. All the authors read and approved the final manuscript. Funding {4} This research is part of the Chief Investigator’s Doctorate of Clinical Science with The University of Manchester and is unfunded. There are no funding requirements for this research trial, as the research is being conducted within an existing clinical service. The participants sourced their own olive oil solution as per normal clinical process. Patient and public representatives who gave initial feedback on the research study were offered a £25 Amazon voucher for their participation and time, and this funding was accessed from the Betsi Cadwaladr University Health Board (BCUHB) Audiology Charitable funds. Availability of data and materials {29} Anonymized data following the end of the research study will be authorised by the sponsor. The research team will be responsible for archiving all video otoscopy consent forms and GP practice patient slips that contain participant email addresses and clinical data records. These records and anonymized data will be retained for a minimum of 5 years after completion of the trial. Ethics approval and consent to participate {24} London – Riverside Research Ethics Committee 24/LO/0420 gave a favourable ethical opinion for this trial on 15 July 2024, and the Health Research Authority and Health and Care Research Wales approvals are in place (Integrated Research Application System (IRAS) 316799). Presumed consent is in place for this research since patients will be directed to use one of two standard methods for softening ear wax (drops or sprays). However, patients may opt out of their data being used for research purposes by requesting this to the audiology practitioner at their clinical appointment. Written informed consent will be received from a select number of patients where a video otoscope image is taken for verification of visualisation ratings. Consent for publication {32} Consent for publication is not applicable, as no patient data are being disclosed. Competing interests {28} The authors declare that they have no competing interests. Authors’ information (optional) This research is conducted as part of LLJ’s higher specialist scientist training (HSST), which involves completing a Doctorate of Clinical Science at the University of Manchester. References Guest JF, Greener MJ, Robinson AC, Smith AF. Impacted cerumen: composition, production, epidemiology and management. QJM. 2004;97(8):477-88. doi: 10.1093/qjmed/hch082. Poulton S, Yau S, Anderson D, Bennett D. Ear wax management. Aust Fam Physician. 2015;44(10):731-734. Available from: https://www.ncbi.nlm.nih.gov/pubmed/26484488. NICE. Hearing loss in adults: assessment and management.[Internet]. 2018 [cited 2025 Jan 31]. Available from: https://www.nice.org.uk/guidance/ng98 Swain SK, Anand N, Sahu MC. Human Cerumen and its Antimicrobial Properties: Study at a Tertiary Care Teaching Hospital of Eastern India. Annals of Indian Academy of Otorhinolaryngology Head and Neck Surgery. 2019; 3:13-16. Cronin T, Zhao F. Temporary threshold shift following ear canal microsuction. Int J Audiol. 2020; 59(9):713-718. doi: 10.1080/14992027.2020.1746977. Islamoglu Y et al. Assessment of SARS-CoV-2 in the Cerumen of COVID-19-Positive Patients. Ear Nose Throat J. 2021;100(2_suppl):155S-157S. doi: 10.1177/0145561320966067. Meador JA. Cerumen impaction in the elderly. J Gerontol Nurs. 1995; 21(12):43-5. doi: 10.3928/0098-9134-19951201-09. No author. Wax in the ear. Br Med J. 1972; 4(5841):623-4. Available at: https://www.ncbi.nlm.nih.gov/pubmed/4645888. Sharp JF, Wilson JA, Ross L, Barr-Hamilton RM. Ear wax removal: a survey of current practice. BMJ. 1990; 301(6763):1251- 3. doi: 10.1136/bmj.301.6763.1251. Hawkins J. Ear wax can cause extraordinary pain. BMJ. 2016;355:i5555. doi: 10.1136/bmj.i5555. Fullington D et al. Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen. BMC Ear Nose Throat Disord. 2017;17:5. doi: 10.1186/s12901- 017-0038-8. Schwartz SR et al. Clinical Practice Guideline (Update): Earwax (Cerumen Impaction) Executive Summary. Otolaryngol Head Neck Surg. 2017;156(1):14-29. doi: 10.1177/0194599816678832. Horton GA, Simpson MTW, Beyea MM, Beyea JA. Cerumen Management: An Updated Clinical Review and Evidence-Based Approach for Primary Care Physicians. J Prim Care Community Health. 2020;11:2150132720904181. doi: 10.1177/2150132720904181. Launer J. Waxing lyrical: taking ear wax seriously. Postgrad Med J. 2021;97(1149):475-476. doi: 10.1136/postgradmedj-2021-140415. Naples JG. Understanding Ear Wax (Cerumen) and Ear Cleanings JAMA Otolaryngol Head Neck Surg. 2022;148(4):388. Munro KJ, Giles TC, Smith-Howell C, Nazareth I.Earwax management in primary care: what the busy GP needs to know. British Journal of General Practice. 2023;73:90-92. McCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75(10):1523-8. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17555144. Meyer F et al. Cerumen Impaction Removal in General Practices: A Comparison of Approved Standard Products. J Prim Care Community Health. 2020;11:2150132720973829. doi: 10.1177/2150132720973829. Aaron K, Cooper TE, Warner L, Burton MJ. Ear drops for the removal of ear wax. Cochrane Database Syst Rev. 2018;7:CD012171. doi: 10.1002/14651858.CD012171.pub2. Prowse SJ, Mulla O. Aural microsuction for wax impaction: survey of efficacy and patient perception. J Laryngol Otol. 2014;128(7):621-5. doi: 10.1017/S0022215114000796. Wright T. Ear wax. BMJ Clin Evid. 2015;Mar 4:2015:0504 Keane EM, Wilson H, McGrane D, Coakley D, Walsh JB. Use of solvents to disperse ear wax. BJCP. 1995;March/April,49(2):71-72. Chalishazar U, Williams H. Back to basics: finding an optimal cerumenolytic (earwax solvent). Br J Nurs. 2007;16(13):806-8. doi: 10.12968/bjon.2007.16.13.24247. Oron Y, Zwecker-Lazar I, Levy D, Kreitler S, Roth Y. Cerumen removal: comparison of cerumenolytic agents and effect on cognition among the elderly. Arch Gerontol Geriatr. 2011;52(2):228-32. doi: 10.1016/j.archger.2010.03.025. Clegg AJ. The safety and effectiveness of different methods of earwax removal: a systematic review and economic evaluation. Health Technol Assess. 2010;14(28):1-192. doi: 10.3310/hta14280. Campbell MK, Piaggio G, Elbourne DR, Altman DG.Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661. Cite Share Download PDF Status: Published Journal Publication published 18 Dec, 2025 Read the published version in Trials → Version 1 posted Editorial decision: Minor revision 18 Sep, 2025 Reviewers agreed at journal 31 Aug, 2025 Reviewers invited by journal 09 Jul, 2025 Editor invited by journal 12 Jun, 2025 Editor assigned by journal 12 May, 2025 First submitted to journal 07 Apr, 2025 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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-6394074","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":483004206,"identity":"fce6b681-0686-41d1-8d66-761e6d0a77b6","order_by":0,"name":"Linor Llwyd 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Manchester","correspondingAuthor":false,"prefix":"","firstName":"Kevin","middleName":"James","lastName":"Munro","suffix":""},{"id":483004208,"identity":"6702ca58-8559-455f-b3f1-11e9967f8b3f","order_by":2,"name":"Jane Wild","email":"","orcid":"","institution":"Bwrdd Iechyd Prifysgol Betsi Cadwaladr: NHS Wales Betsi Cadwaladr University Health Board","correspondingAuthor":false,"prefix":"","firstName":"Jane","middleName":"","lastName":"Wild","suffix":""}],"badges":[],"createdAt":"2025-04-07 12:09:30","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6394074/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6394074/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13063-025-09378-5","type":"published","date":"2025-12-18T15:58:19+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":86670642,"identity":"299910b8-82a5-4ee3-8709-ff9b0682c211","added_by":"auto","created_at":"2025-07-14 11:30:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":35581,"visible":true,"origin":"","legend":"\u003cp\u003eA comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6394074/v1/991ebfd47a60681b3fff342f.png"},{"id":98814019,"identity":"75106d8c-75b7-4e8c-89f5-a747e14d43be","added_by":"auto","created_at":"2025-12-22 16:09:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1443164,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6394074/v1/a36a7299-7813-4325-9738-da87776e49c1.pdf"}],"financialInterests":"","formattedTitle":"A comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial.","fulltext":[{"header":"Administrative information","content":"\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"639\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eTitle {1}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eA comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eTrial registration {2a and 2b}.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eISRCTN28211073\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eProtocol version {3}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003e20\u003csup\u003eth\u003c/sup\u003e November 2024\u003c/p\u003e\n \u003cp\u003eVersion 2.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eFunding {4}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eNone \u0026ndash; trial run within existing clinical service.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eAuthor details {5a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eLinor Llwyd Jones, Principal Clinical Scientist, Audiology, Betsi Cadwaladr University Health Board\u003c/p\u003e\n \u003cp\[email protected]\u003c/p\u003e\n \u003cp\u003e03000 843864\u003c/p\u003e\n \u003cp\u003eProf. Kevin J Munro, Ewing Professor of Audiology, The University of Manchester\u003c/p\u003e\n \u003cp\[email protected]\u003c/p\u003e\n \u003cp\u003e0161 275 8678\u003c/p\u003e\n \u003cp\u003eJane Wild, Consultant Clinical Scientist, Audiology, BCUHB\u003c/p\u003e\n \u003cp\[email protected]\u003c/p\u003e\n \u003cp\u003e03000 843863\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eName and contact information for the trial sponsor {5b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eLaura Longshaw, Deputy Research \u0026amp; Development Manager, Betsi Cadwaladr University Health Board\u003c/p\u003e\n \u003cp\[email protected]\u003c/p\u003e\n \u003cp\u003e03000 856766\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 218px;\"\u003e\n \u003cp\u003eRole of sponsor {5c}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 421px;\"\u003e\n \u003cp\u003eSponsor has the overall responsibility for ensuring that proportionate, effective arrangements are in place to set up, run and report this research study. In addition to being responsible for monitoring and audit activities, the Sponsor will advise the Chief Investigator on the study design, collection, management, analysis and report writing in accordance with our Standard Operating Procedures for Research.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Introduction","content":"\u003cp\u003e\u003cstrong\u003eBackground and rationale {6a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEarwax is a naturally occurring substance that is produced within the ear and forms part of the ear\u0026rsquo;s self-cleaning and protective mechanism. It achieves this by trapping dust and dirt and removing them from the ear canal, resulting in antibacterial and antifungal properties [1-6]. Earwax usually migrates out of the ear canal via natural jaw actions, such as chewing and talking, but in some cases, it can accumulate excessively, leading to occlusion within the external ear canal. This causes various unwanted symptoms, the most common being hearing loss, with other self-reported symptoms such as tinnitus, a blocked ear, changes in the quality of one\u0026rsquo;s own voice, pain or discomfort, coughing, irritation, infections and even dizziness [1,3,5,7-16]. Munro et al. [16] reported that the most common symptom of earwax was hearing loss (86.4% of patients), which affects daily living, including listening to TV and environmental awareness. Occluding earwax can also have a negative effect on a person\u0026rsquo;s quality of life by causing social withdrawal, reduced function at work, mild paranoia and disorientation [1,11,14].\u003c/p\u003e\n\u003cp\u003eThe prevalence of problematic earwax is reported to be approximately 2.3 million people per year, or 5% of the general adult population, which is as high as 65% of the elderly population [1,11]. Occluding wax will only clear spontaneously in 5% of cases, which explains why earwax removal, which is the most common ENT procedure undertaken in primary care, is performed on 4 million ears per year in the UK with the goal of resolving or reducing these unwanted symptoms [1,12,17].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRationale\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDespite earwax removal being a relatively common procedure, there is limited high-quality evidence on the most effective removal method. Many studies recommend the use of a wax softener prior to mechanical removal [18]. Wax softeners have been used for many years in all healthcare settings for the management of wax as a pretreatment prior to mechanical removal [2,18-20]. There are various pretreatment wax softeners available, and studies have shown no difference in the use of olive oil, water or any other wax softener [1,13,19-21]. Using a wax softener alone may lead to complete clearance of the wax in approximately 20\u0026ndash;22% of cases, but most often, it needs to be combined with mechanical removal [13,19,22,23].\u003c/p\u003e\n\u003cp\u003eThe NHS Audiology Primary Care service in North Wales offers a wax removal service located at GP practices. This is a needs-based pathway in which patients reporting symptoms consistent with excessive earwax can self-refer, or patients can be referred by professionals who confirm the presence of earwax that restricts a full view of the tympanic membrane for earwax removal. All patients are advised to use olive oil drops or spray as a pretreatment wax softener followed by attempted earwax removal via microsuction by audiology practitioners as a first-line treatment. The service evaluation data revealed that one in four patients required a return visit for a second attempt at wax removal, with the first attempt being unsuccessful due to incomplete removal of wax, as reported by the audiology practitioner. Anecdotal evidence from our practitioners suggests that administering olive oil as a spray may lead to improved success of wax removal compared with the traditional method of administering drops. This may be due to more effective coverage and contact with the wax, which is in agreement with Oron et al. [24], who reported that spray may penetrate deeper into the ear canal during application.\u003c/p\u003e\n\u003cp\u003eThis large-scale cluster randomised control trial aims to compare the administration methods of olive oil drops and olive oil spray as a pretreatment wax softener prior to wax removal by microsuction. No previous study has investigated whether the application of wax softeners via different methods affects the outcome of wax removal. The trial has full support from a public and patient involvement (PPI) group who has been consulted throughout the trial design and who will also be involved in the analysis and dissemination of results. PPI individuals reported this research to be valuable and important, especially within the theme and focus on preventative care and care in the community.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives {7}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePrimary objective:\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eTo compare the success of wax removal following the use of olive oil pretreatment with wax softener intervention (spray) and comparator (drops) for 7 days prior to microsuction. The success of wax removal is determined by complete clearance of wax not requiring a second visit to the clinic, as reported by the audiology practitioner upon otoscopic examination following microsuction.\u003c/p\u003e\n\u003cp\u003eSecondary objectives:\u003c/p\u003e\n\u003cp\u003eThe secondary objective outcomes will be compared between the olive oil drop and olive oil spray groups.\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eTo explore improvements in self-reported symptoms following wax removal, a self-reported improvement scale is used.\u003c/li\u003e\n \u003cli\u003eTo investigate the postmicrosuction visualisation ratings (a measure of the amount of residual wax).\u003c/li\u003e\n \u003cli\u003eThe occurrence of adverse events associated with microsuction are monitored according to Clegg et al.[25].\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eTrial design {8}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis RCT is a parallel, two-arm, superiority cluster randomisation trial design to compare the effectiveness of olive oil drops and olive oil spray when used as a pretreatment wax softener prior to wax removal by microsuction. A cluster randomised design was chosen to ease the organisation of the trial, as it takes place within a current clinical service, and individual randomisation would add to the workload and make the trial difficult to undertake. Twenty-six GP practices will be included and randomised via a one-to-one allocation ratio to either the intervention arm (olive oil spray) or the comparator arm (olive oil drops) prior to the start of the study. The trial is designed to have a pragmatic approach, with the data analysed via an intention-to-treat analysis. Figure 1 presents the trial flow chart. Minimal changes are introduced to the service as part of this trial but include:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eVerification of one of the secondary outcomes, which involves reporting the amount of residual wax following microsuction by the audiology practitioner. The amount of residual wax following microsuction is recorded by the audiology practitioner via a visual verification rating (0-3); see Table 1. A video otoscopy image will be taken with patient consent and sent to an independent professional, who will rate the amount of residual wax using the verification ratings. The ratings of the audiology practitioner and independent professional will be compared to verify the reliability of this outcome.\u003c/li\u003e\n \u003cli\u003ePatients will be given a feedback slip at the end of the appointment with the audiology practitioner and asked to select which pretreatment wax softener they used. This information will be used to check adherence to the protocol when analysing the outcomes given that the pretreatment wax softener is purchased and self-administered by the patient.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Methods: Participants, interventions and outcomes","content":"\u003cp\u003e\u003cstrong\u003eStudy setting {9}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will run within 26 NHS-funded GP practices that deliver the NHS Audiology Primary Care wax removal service across North Wales. The earwax removal service is delivered by audiology practitioners. Patients with symptoms, or a clinical need, can self-refer, be referred by their audiology practitioner, GP or other healthcare professional working in the practice. The research will not change service provision or routine clinical care for research participants or other patients seen within the service during the research timeline.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria {10}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll adults over 18 years of age with the presence of earwax in one or both ears are eligible for the study.\u003c/p\u003e\n\u003cp\u003eInclusion criteria:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eAdults over 18 years of age\u003c/li\u003e\n \u003cli\u003eProvide informed consent for microsuction\u003c/li\u003e\n \u003cli\u003ePresence of wax given rise to symptoms or need that warrants removal\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe exclusion criteria include:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eUnder 18 years of age\u003c/li\u003e\n \u003cli\u003eActive ear infection\u003c/li\u003e\n \u003cli\u003eActive dermatitis\u003c/li\u003e\n \u003cli\u003ePerforated or nonintact tympanic membrane\u003c/li\u003e\n \u003cli\u003eForeign bodies present in the ear canal\u003c/li\u003e\n \u003cli\u003eAny contraindication for microsuction or use of wax softeners \u0026ndash; previous ear surgery including mastoid obliteration; grommets in situ\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWho will provide informed consent? {26a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsent to participate in this trial will be presumed, as the study participants in both arms are NHS patients accessing standard NHS care, and this approach has been approved by ethics. The only difference between the two arms is that patients will be advised to use either pretreatment olive oil drops or spray rather than having a free choice of using either solution.\u003c/p\u003e\n\u003cp\u003eWritten consent will be obtained from a selection of patients as part of the verification of visualisation ratings for outcome verification (see Figure 1). Five patients seen by 90% of the audiology practitioners will be asked to provide consent for a video otoscopy image of their external ear canal. The CI will obtain informed consent and take video otoscope images. This image will be shared with an independent professional for outcome verification purposes. A copy of these signed and dated forms will be kept in the patient\u0026rsquo;s audiology records, and another file with trial documentation will be included in the research file. These will not be shared with anyone outside the research team.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional consent provisions for the collection and use of participant data and biological specimens {26b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable \u0026ndash; There are no additional consent provisions for sharing data with others in this trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExplanation for the choice of comparators {6b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe comparator in this trial is olive oil drops, which are traditionally the most commonly used pretreatment wax softener within our wax removal service. The olive oil will be self-administered at home by the patient, or a significant other, at a recommended dose of 3 drops per ear once a day for 7 days prior to the wax removal appointment. Following feedback from the PPI individuals, advice was given from a Trial Pharmacist, who confirmed that olive oil sold for wax removal purposes in pharmacies has been through medical-grade testing rather than ordinary kitchen olive oil, so this is recommended for use as part of this trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention description {11a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention in this trial is olive oil spray. Patients will be advised to use the allocated olive oil solution when booking their wax removal appointment at the GP practice. The olive oil will be self-administered at home by the patient, or a significant other, at a recommended dose of 3 sprays per ear once a day for 7 days prior to the wax removal appointment. Notably, olive oil spray has a greater cost than does the comparator. This was discussed with the PPI individuals, who deemed the price difference acceptable and unlikely to influence many participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll patients will be encouraged to follow the pretreatment advice as part of this trial. The option to discontinue or modify the pretreatment advice will be at the discretion of the healthcare practitioner should this be clinically indicated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrategies to improve adherence to interventions {11c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatient information leaflets are available at participating GP practices that specifically instruct patients to administer pretreatment olive oil as per the allocation of the GP practice. The patient information leaflet highlights that the research is being carried out to investigate any differences between these two administration methods, hence the importance of adhering to the intervention.\u003c/p\u003e\n\u003cp\u003eStaff reminder slips will be issued to GP practices to be placed in reception and administration offices. Additionally, staff members will be reminded regularly of the importance of encouraging patients to use the allocated solution both by the research team and the Audiology Primary Care team.\u003c/p\u003e\n\u003cp\u003eFollowing PPI feedback regarding the occasional lack of stock of olive oil spray in community pharmacies, local community pharmacy networks have been informed of the research to encourage local pharmacies to keep stock of both drops and sprays for patients to purchase locally.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients may be offered concomitant care for hearing or balance assessment alongside this trial if needed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProvisions for posttrial care {30}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable to this trial, as patients will only remain in the trial for the duration of one clinical visit, and there are no other deviations from normal clinical care.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes {12}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePrimary outcome\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome is a comparison of the success of wax removal across the two groups. Success of wax removal is measured by the Audiology Practitioner, who inspects the ear and calculates the proportion of patients where wax removal is successful (0 or 1 as defined in Table 1) at the first attempt and who do not need a repeat visit (2 or 3 as defined in Table 1).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe secondary outcomes include the following:\u003c/p\u003e\n\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eImprovements in self-reported symptoms (reported by patients during clinic visits prior to microsuction) measured via a 5-point improvement rating scale (much better, slightly better, about the same, slightly worse, and much worse) following wax removal in the two groups.\u003c/li\u003e\n \u003cli\u003eDifferences in the amount of residual wax following microsuction are measured by a postmicrosuction visualisation rating reported by the audiology practitioner through visual inspection of the ear. See Table 1.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u0026nbsp;Table 1. Descriptors for visualisation ratings used postmicrosuction by audiology practitioners\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 141px;\"\u003e\n \u003cp\u003eVisualisation rating\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 460px;\"\u003e\n \u003cp\u003eExplanation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 141px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 460px;\"\u003e\n \u003cp\u003eNo or very minimal earwax, complete visualisation of tympanic membrane\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 141px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 460px;\"\u003e\n \u003cp\u003eMinor amount of earwax with majority of tympanic membrane visible\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 141px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 460px;\"\u003e\n \u003cp\u003eModerate amount of earwax with only part of the tympanic membrane visible\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 141px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 460px;\"\u003e\n \u003cp\u003eFully occluding wax, no visualisation of tympanic membrane\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003ec. Adverse events. All adverse events that occur in the clinic during or immediately after microsuction and any reported by patients up to one week after microsuction, will be recorded as per normal clinical practice.\u003c/p\u003e\n\u003cp\u003eA further exploratory analysis will be completed on the following:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThe effect of age on the success of wax removal.\u003c/li\u003e\n \u003cli\u003eSuccess of wax removal in patients who do not use any pretreatment.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant timeline {13}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients are involved in the study for wax removal. The trial requires one clinic visit for every patient. Patients will be advised to use the allocated intervention for seven days prior to their appointment and then will visit the clinic for the wax removal appointment. This is shown in the trial flow chart (see Figure 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size {14}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA total sample size of 1,742 participants across 26 clusters/GP practice (67 participants in each practice) was calculated as sufficient to detect a minimal clinically important difference of 9%, with an 80% power level and 5% significance. The sample size for this trial was determined via \u0026lsquo;The Shiny CRT Calculator\u0026rsquo; (accessible here: https://clusterrcts.shinyapps.io/rshinyapp/lculator: Power and Sample size for Cluster Randomised Trials (shinyapps.io)). The following parameters were used (trial design = parallel; correlation structure = exchangeable; differential clustering = false; allowance for varying cluster sizes = yes; coefficient of variation = 0.527; number of clusters per arm = 13; intracluster correlation = 0.02; ICC lower extreme = 0.01; ICC upper extreme = 0.05; outcome type = binary; proportion under control = 0.74; proportion under investigation = 0.83).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe above parameters were determined via discussion with statisticians and by professional consensus. A consensus was reached among 13 professionals regarding the minimal clinically important difference in the use of a specified pretreatment wax softener. The majority of the responses from the 13 professionals were between 6% and 10%, so for a conservative approach, we decided to use 9%, which was also the average.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe NHS Audiology wax removal service in North Wales is still in the process of roll out, and the actual number of GP practices participating in the study may be greater than 26. If this is the case, the sample size calculation will be reviewed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment {15}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe participants will be individual NHS patients who access the earwax removal service. They will be identified by the GP surgery administration teams or healthcare staff as per usual practice (patient contacts or is advised by healthcare professionals to request an appointment for wax removal or reporting symptoms/needs that are thought/confirmed to be because of wax build-up). The normal procedure for booking a wax removal appointment will be followed, and staff at the GP practice will be fully informed of the research. When booking the appointment, patients will be informed of the pretreatment they should use for seven days prior to their wax removal appointment by the staff member booking their appointment. Patients can book their appointment face-to-face whilst visiting the surgery or by telephone. Patients will be offered written information about using the pretreatment and will be directed to a video to watch if needed. Patients will be advised to purchase their olive oil drops or olive oil spray from a pharmacy as usual clinical care.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: allocation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSequence generation {16a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRandomisation will take place at a cluster level (GP practice) with a one-to-one allocation ratio to the two groups of olive oil drops or olive oil spray via stratified block randomisation on the basis of prognostic value. Stratifying was performed on the basis of site size (small, large) with block sizes of 2 and 4. A total of 26 clusters will be randomised. Randomisation is performed via the randomisation software Sealed Envelope.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConcealment mechanism {16b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe CI will implement the allocation sequence and inform each GP practice of their allocation via email and personal visits. All precautions will be taken to conceal the randomisation allocation from the audiology practitioners delivering the earwax removal service, but patients may accidentally disclose this, or practitioners may be able to identify the pretreatment product used on the basis of otoscopy findings. Throughout the research, each GP practice is identified and allocated by a unique numerical code only known by the CI.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation {16c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe CI will generate the allocation sequence, enroll GP practices and assign the interventions to the clusters (GP practices). As a pragmatic trial, the research is happening within normal clinical practice; therefore, patients are not officially enrolled in the study, but rather, the GP practice staff (receptionist, healthcare staff) will inform the patient of the research when booking in for the wax removal appointment. The GP practice staff will be responsible for informing the patients of the allocated intervention (olive oil drops or spray).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: Blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho will be blinded {17a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCare providers (audiology practitioners) and the outcome verification professional will be blinded to the assignment of interventions, but we cannot accommodate patients accidentally disclosing this information during their appointment. The majority of audiology practitioners see patients from various GP surgeries at one or more locations, meaning that they are likely to see patients who have been allocated to both the comparator and the intervention during a single clinical session. Only the CI will be aware of the complete assignment of interventions, and the primary care audiology clinical leaders and GP staff members at each individual practice will be aware of their own assigned intervention. It is not possible to blind the trial participants to the assigned intervention.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProcedure for unblinding if needed {17b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere is no requirement for a procedure for unblinding during this trial, as there is no risk associated with the blinding, as both interventions are the same solution only delivered in a different manner.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for assessment and collection of outcomes {18a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial will use routine clinical data collected from patients accessing the audiology wax removal service. No additional data are collected as part of this research, which is not routinely collected for service evaluation. No patient identifiable data are collected, and all data are recorded at the microsuction appointment visit. The premicrosuction data recorded included date, location, age, referral source and self-reported presenting symptoms. The postmicrosuction data recorded included the amount of residual wax in each ear (visualisation rating) and the degree of improvement in self-reported presenting symptoms using a 5-point scale (much better, somewhat better, no change, somewhat worse, much worse). All the data are recorded during a single clinic visit.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll the data collected will be recorded on a password-protected Excel spreadsheet currently used by audiology practitioners for evaluation purposes. The spreadsheet is kept online on the Audiology Sharepoint intranet site, meaning that it is accessible to all audiology practitioners working at various NHS locations.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOnly patients with a complete outcome dataset were included in the final analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformation about the research trial is included on the NHS audiology service\u0026rsquo;s external website and as posters in the participating GP practices to raise awareness.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIf patients report that they have not complied with advice and have not used a pretreatment wax softener, the audiology practitioner will continue to attempt to remove any wax via microsuction via routine service delivery. The data for these patients will be analysed separately from those for the other patients in an exploratory analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData management {19}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll research data will be recorded and held on a password-protected Excel spreadsheet on the internal NHS Audiology services\u0026rsquo; online Sharepoint site, as is the current practice for service evaluation. The data will be accessible by all audiology practitioners working at the wax removal service, their service leads and the CI of the trial. There will be a focus on ensuring that the data are accurate, eligible, complete, consistent and available when needed, hence the reason for it being kept in an easily accessible location. The CI will extract the required data from the source file for analysis purposes. The data will not be shared with anyone outside the research team at any time.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA numerical identification code will be allocated to the selection of patients who consent for a video otoscopy image of their ear following microsuction. This code will be added to their corresponding data input on the main spreadsheet by the CI and on their photographic consent form. The numerical code and corresponding consent form with the patient name will only be available and known by the CI.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePatients will have the opportunity to share their email address to receive a summary of the trial outcomes. Their email address will not be able to be linked back to their research data entry and will be shared only with the CI. The email address will be recorded on individual GP practice patient slips alongside a GP clinic code related to the research allocation. The GP clinic codes and allocated treatment details will be stored electronically on the internal NHS Audiology online Sharepoint site in a password-protected Excel spreadsheet accessible only by the CI. This will be deleted at the end of data collection.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBoth the written video otoscopy consent forms and the GP practice patient slips with completed email addresses will be stored in the research file within a locked cabinet that will be accessible only by the CI.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn compliance with good clinical practice (GCP), all documentation relevant to the trial will be retained for a period of 5 years following the end of the RCT. Further information on data management can be found within the protocol.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConfidentiality {27}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo patient identifiable information is collected as part of this research study apart from the individuals who are selected and consent to the video otoscopy verification exercise and those who volunteer to share their email address at the end of the clinic visit to be informed of the research outcome. Both the photography consent forms and completed GP practice patient slips with email addresses will be stored in the research file in a locked cabinet at the main NHS hospital site, accessible only by the CI. Any link between codes and identifiers on consent forms will be deleted at the end of data collection.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable \u0026ndash; no biological samples are collected or evaluated in this trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAnalysis and reporting of the trial will follow the Consolidated Standards of Reporting Trials (CONSORT) guidelines for cluster trials [26].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor the primary outcome analysis, a mixed effects logistic regression model will be fitted to the data with a random intercept for cluster and a fixed effect for wax softener delivery type (olive oil drops or olive oil spray) and strata (small or large GP practice). A correction factor is applied to reduce the risk of inflating the type I error rate due to the small number of clusters (\u0026lt;40).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor the secondary outcomes investigating visualisation ratings and improvement in self-reported symptoms, we will use a linear mixed effects ordinal regression model with a random intercept for both cluster and patients and a fixed effect for wax softener delivery type (olive oil drops or olive oil spray) and strata (small or large GP practice). To investigate whether the reported improvement in self-reported symptoms/needs of patients who used olive oil drops significantly differed from that of patients who used olive oil spray, the unit of analysis is patient. To analyse whether there was a difference in the amount of residual wax measured by visualisation ratings between the olive oil drops and spray groups, the unit of analysis is the ear. The number of adverse events reported in the two groups will be analysed descriptively because of the likely low number of adverse events. Further details of the statistical analysis plan can be found within the protocol.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterim analyses {21b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial includes an internal pilot that involves conducting the study as planned within a sample (10%) of the GP practices. Data will be collected as per the full study, and the Red, Amber, and Green criteria will be used. If there is less than 50% compliance (red) with the protocol, data collection will stop, and urgent training visits will be arranged to ensure that patients receive appropriate advice from healthcare professionals on the use of the allocated intervention. When compliance is between 50% and 70% (amber), data collection may be paused temporarily, and GP practices may be in contact with a research reminder. If compliance is 80% (green), data collection will continue.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA planned interim analysis involves verifying the visualisation ratings following microsuction. The audiology practitioner uses a numerical visualisation rating to categorise how much wax remains in the ear following microsuction attempt. To verify these ratings, an anonymised photograph of the external ear canal and ear drum will be taken via a video otoscope with individual patient consent. The image is saved via a numerical code that is related to the GP practice and the age of the patient. The image is then shared with an independent experienced professional who views the image and records an independent visualisation rating. This rating will be compared with the audiology practitioner\u0026apos;s rating, and a Red, Amber, Green strategy (as above) will be used to validate the agreement in ratings.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods for additional analyses (e.g., subgroup analyses) {20b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eExploratory analysis of the effect of age will be performed by rerunning the primary and secondary analyses with an additional covariate of the fixed effect of age to the multilevel model.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAdditionally, we expect that some patients will not adhere to the protocol and will not use any pretreatment wax softeners before attending their wax removal appointment. We will repeat the primary and secondary analyses and add a covariate fixed effect of no pretreatment used in the multilevel model. Further details can be found in the protocol.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods in analysis to handle protocol nonadherence and any statistical methods to handle missing data {20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA sensitivity analysis will be run by removing the patients who did not use pretreatment and rerunning the analyses of the primary and secondary outcomes. As all the data are nonidentifiable, there will be no way of identifying individual patients who have not adhered to the protocol. Only patients with a full dataset were included in the analysis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to give access to the full protocol, participant-level data and statistical code {31c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAnonymized data can be made available from the authors upon reasonable request upon completion of the trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOversight and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial is coordinated and monitored by the CI with support from the protocol contributors. The CI will have oversight and ongoing monitoring during data collection. There is no formal Trial Steering Committee or monitoring committee associated with this trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the data monitoring committee, its role and reporting structure {21a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo data monitoring committee is required for this trial, as the trial is run within an existing clinical service for which the CI will monitor on an ongoing basis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse event reporting and harms {22}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdverse events are not anticipated during this trial, as the two interventions are routinely used. Unexpected severe adverse events (SAEs) associated with the standard care intervention (ear wax removal) will be reported to the sponsor as per our Standard Operating Procedure for Safety Reporting and further assessed by the CI in addition to following standard clinical care procedures. Nonsevere adverse events will be recorded, assessed, reported and managed as per normal service delivery and departmental policy and as stated in the research protocol.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFrequency and plans for auditing trial conduct {23}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial conduct will be monitored by a sponsor-appointed monitor throughout the trial life cycle according to the sponsor risk assessment and a trial-specific monitoring plan per standard operating procedures. The study was deemed low risk; however, it may be included in routine audits conducted by the sponsor according to the sponsor audit schedule.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProtocol amendments will require local approval by the sponsor, ethics committee and healthcare research workers (HCRWs) before implementation. The amendment will then be shared with all participating GP practices, the audiology team delivering the wax removal service, investigators, RECs, trial registries, journals and research sponsors.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination plans {31a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTrial patients have the opportunity to note their email address if they would like to hear about the trial outcomes. At the end of the trial, a summary of the research and the outcome will be shared with all patients who opt to share their email addresses.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe research and outcomes will be published nationally in a peer-reviewed journal and at national/international conferences. The findings will be shared within the field of audiology and further within general healthcare networks. We are investigating ways to minimise barriers to the implementation of research findings by involving healthcare practitioners who will be providing this advice to patients in this trial (GP practice staff). Should the research show that either the intervention or comparator is more effective as a pretreatment wax softener, this information will be used to change recommendations to patients at all Wales service levels following approval from the Wales Audiology Heads of Service Group. The information will also be shared with the British Society of Audiology as new evidence for consideration to inform an update to the Aural Care (Ear Wax Removal) Practice Guidance and shared with NICE to supplement future recommendations for wax management.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis research aims to answer an important question, as deemed by PPI individuals, that has the potential to impact national guidance on wax removal procedures. This pragmatic RCT runs within a current clinical service and has been designed to reflect real-life clinical practice and minimise disruption to clinical services. Audiology practitioners at any level do not currently have prescribing rights; thus, this trial is restricted by an inability to supply the olive oil solution to patients, meaning that we have adhered to the current clinical procedure in that patients source the olive oil solution themselves. This does carry a potential risk of patients not adhering to the protocol owing to product availability, issues sourcing the solution locally or failure to follow clinical recommendations. Following PPI feedback, we have attempted to minimise this by contacting community pharmacy teams across North Wales, informing them of the research and advising them to stock both olive oil drops and olive oil spray in their pharmacies for the benefit of this research and by using patient information materials and posters that highlight the importance of this research.\u003c/p\u003e\n\u003cp\u003eThe data will be analysed via an intention-to-treat analysis. This may mean that any difference between the two groups will be minimised, indicating that the pragmatic approach taken with the aim of better reflecting a real-life clinical situation may be seen as a strength of the trial. An alternative approach would need to be highly regulated, and any findings may not necessarily be effective in real life.\u003c/p\u003e\n\u003cp\u003eData collection is to be completed by audiology practitioners, and no additional data are being collected compared with those already being collected for data evaluation purposes. We hope this will help ensure that there are no missing data entries. All audiology practitioners involved in the service will be aware of the RCT, and its objectives and clinical leaders of the service will be involved and approved for the study design.\u003c/p\u003e\n\u003cp\u003eThe findings of this research will only be applicable to the use of pretreatment with the wax softener olive oil followed by the mechanical removal method of microsuction. Further research will be needed to determine whether the same findings apply to other pretreatment wax softeners or mechanical removal methods, such as irrigation.\u003c/p\u003e\n\u003cp\u003eThe research is run within 26 sites across North Wales. While the CI will maintain close contact with all the sites during the research, the risk remains that primary care staff booking the wax removal appointment and advising patients on the use of pretreatment wax softeners may not give the correct advice or may not emphasise the importance of adhering to recommended guidance. To help support this, each cluster site has been issued staff reminder slips that are displayed behind reception and in staff areas as reminders of the advice that should be given to patients.\u003c/p\u003e\n\u003cp\u003ePPI representatives were included in the development of the study design through focus groups and email correspondence. Their input shaped the design of the protocol and methodology by validating the design and informing protocol details such as the difference between olive oil sold in pharmacies for wax removal purposes and ordinary kitchen olive oil and acceptance of price differences to patients between the investigator and comparator product. All PPI individuals approved the trial as important research and supported the ethical approval process. The PPI individuals will be kept informed of the progress of the trial as the research progresses.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eProtocol version 2.2\u003c/p\u003e\n\u003cp\u003e20\u003csup\u003eth\u003c/sup\u003e November 2024.\u003c/p\u003e\n\u003cp\u003eRecruitment for the study began on 1\u003csup\u003est\u003c/sup\u003e January 2025, and we approximate the end of data collection on 1\u003csup\u003est\u003c/sup\u003e July 2025.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eAE Adverse Event\u003c/p\u003e\n\u003cp\u003eBCUHB Betsi Cadwaladr University Health Board\u003c/p\u003e\n\u003cp\u003eCI Chief Investigator\u003c/p\u003e\n\u003cp\u003eENT Ear, Nose and Throat\u003c/p\u003e\n\u003cp\u003eGCP Good clinical practice\u003c/p\u003e\n\u003cp\u003eGP General Practice\u003c/p\u003e\n\u003cp\u003eHCRW Health Care Research Wales\u003c/p\u003e\n\u003cp\u003eNHS National Health Service\u003c/p\u003e\n\u003cp\u003ePPI Patient and Public Involvement\u003c/p\u003e\n\u003cp\u003eREC Research Ethics Committee\u003c/p\u003e\n\u003cp\u003eR\u0026amp;D Research and development\u003c/p\u003e\n\u003cp\u003eSAE Serious adverse event\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe main author would like to acknowledge and thank the research team for their advice, help and support in developing this research study. We thank the BCUHB Audiology Primary Care team and GP surgeries and their staff for supporting the research. Additional thanks go to Dr Sarah Rhodes, Statistician, University of Manchester, for her statistical guidance.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions {31b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLLJ conceived the study and led the proposal and protocol development.\u003c/p\u003e\n\u003cp\u003eKM and JW contributed to the study design, development of the proposal and protocol review.\u003c/p\u003e\n\u003cp\u003eAll the authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding {4}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research is part of the Chief Investigator\u0026rsquo;s Doctorate of Clinical Science with The University of Manchester and is unfunded. There are no funding requirements for this research trial, as the research is being conducted within an existing clinical service. The participants sourced their own olive oil solution as per normal clinical process. Patient and public representatives who gave initial feedback on the research study were offered a \u0026pound;25 Amazon voucher for their participation and time, and this funding was accessed from the Betsi Cadwaladr University Health Board (BCUHB) Audiology Charitable funds.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials {29}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAnonymized data following the end of the research study will be authorised by the sponsor. The research team will be responsible for archiving all video otoscopy consent forms and GP practice patient slips that contain participant email addresses and clinical data records. These records and anonymized data will be retained for a minimum of 5 years after completion of the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate {24}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLondon \u0026ndash; Riverside Research Ethics Committee 24/LO/0420 gave a favourable ethical opinion for this trial on 15 July 2024, and the Health Research Authority and Health and Care Research Wales approvals are in place (Integrated Research Application System (IRAS) 316799). Presumed consent is in place for this research since patients will be directed to use one of two standard methods for softening ear wax (drops or sprays). However, patients may opt out of their data being used for research purposes by requesting this to the audiology practitioner at their clinical appointment. Written informed consent will be received from a select number of patients where a video otoscope image is taken for verification of visualisation ratings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication {32}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConsent for publication is not applicable, as no patient data are being disclosed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests {28}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; information (optional)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research is conducted as part of LLJ\u0026rsquo;s higher specialist scientist training (HSST), which involves completing a Doctorate of Clinical Science at the University of Manchester.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGuest JF, Greener MJ, Robinson AC, Smith AF. Impacted cerumen: composition, production, epidemiology and management. QJM. 2004;97(8):477-88. doi: 10.1093/qjmed/hch082.\u003c/li\u003e\n\u003cli\u003ePoulton S, Yau S, Anderson D, Bennett D. Ear wax management. Aust Fam Physician. 2015;44(10):731-734. Available from: https://www.ncbi.nlm.nih.gov/pubmed/26484488.\u003c/li\u003e\n\u003cli\u003eNICE. Hearing loss in adults: assessment and management.[Internet]. 2018 [cited 2025 Jan 31]. Available from: https://www.nice.org.uk/guidance/ng98 \u003c/li\u003e\n\u003cli\u003eSwain SK, Anand N, Sahu MC. Human Cerumen and its Antimicrobial Properties: Study at a Tertiary Care Teaching Hospital of Eastern India. Annals of Indian Academy of Otorhinolaryngology Head and Neck Surgery. 2019; 3:13-16.\u003c/li\u003e\n\u003cli\u003eCronin T, Zhao F. Temporary threshold shift following ear canal microsuction. Int J Audiol. 2020; 59(9):713-718. doi: 10.1080/14992027.2020.1746977.\u003c/li\u003e\n\u003cli\u003eIslamoglu Y et al. Assessment of SARS-CoV-2 in the Cerumen of COVID-19-Positive Patients. Ear Nose Throat J. 2021;100(2_suppl):155S-157S. doi: 10.1177/0145561320966067.\u003c/li\u003e\n\u003cli\u003eMeador JA. Cerumen impaction in the elderly. J Gerontol Nurs. 1995; 21(12):43-5. doi: 10.3928/0098-9134-19951201-09.\u003c/li\u003e\n\u003cli\u003eNo author. Wax in the ear. Br Med J. 1972; 4(5841):623-4. Available at: https://www.ncbi.nlm.nih.gov/pubmed/4645888.\u003c/li\u003e\n\u003cli\u003eSharp JF, Wilson JA, Ross L, Barr-Hamilton RM. Ear wax removal: a survey of current practice. BMJ. 1990; 301(6763):1251- 3. doi: 10.1136/bmj.301.6763.1251.\u003c/li\u003e\n\u003cli\u003eHawkins J. Ear wax can cause extraordinary pain. BMJ. 2016;355:i5555. doi: 10.1136/bmj.i5555.\u003c/li\u003e\n\u003cli\u003eFullington D et al. Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen. BMC Ear Nose Throat Disord. 2017;17:5. doi: 10.1186/s12901- 017-0038-8.\u003c/li\u003e\n\u003cli\u003eSchwartz SR et al. Clinical Practice Guideline (Update): Earwax (Cerumen Impaction) Executive Summary. Otolaryngol Head Neck Surg. 2017;156(1):14-29. doi: 10.1177/0194599816678832.\u003c/li\u003e\n\u003cli\u003eHorton GA, Simpson MTW, Beyea MM, Beyea JA. Cerumen Management: An Updated Clinical Review and Evidence-Based Approach for Primary Care Physicians. J Prim Care Community Health. 2020;11:2150132720904181. doi: 10.1177/2150132720904181.\u003c/li\u003e\n\u003cli\u003eLauner J. Waxing lyrical: taking ear wax seriously. Postgrad Med J. 2021;97(1149):475-476. doi: 10.1136/postgradmedj-2021-140415.\u003c/li\u003e\n\u003cli\u003eNaples JG. Understanding Ear Wax (Cerumen) and Ear Cleanings JAMA Otolaryngol Head Neck Surg. 2022;148(4):388.\u003c/li\u003e\n\u003cli\u003eMunro KJ, Giles TC, Smith-Howell C, Nazareth I.Earwax management in primary care: what the busy GP needs to know. British Journal of General Practice. 2023;73:90-92.\u003c/li\u003e\n\u003cli\u003eMcCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75(10):1523-8. Available at: https://www.ncbi.nlm.nih.gov/pubmed/17555144.\u003c/li\u003e\n\u003cli\u003eMeyer F et al. Cerumen Impaction Removal in General Practices: A Comparison of Approved Standard Products. J Prim Care Community Health. 2020;11:2150132720973829. doi: 10.1177/2150132720973829.\u003c/li\u003e\n\u003cli\u003eAaron K, Cooper TE, Warner L, Burton MJ. Ear drops for the removal of ear wax. Cochrane Database Syst Rev. 2018;7:CD012171. doi: 10.1002/14651858.CD012171.pub2.\u003c/li\u003e\n\u003cli\u003eProwse SJ, Mulla O. Aural microsuction for wax impaction: survey of efficacy and patient perception. J Laryngol Otol. 2014;128(7):621-5. doi: 10.1017/S0022215114000796.\u003c/li\u003e\n\u003cli\u003eWright T. Ear wax. BMJ Clin Evid. 2015;Mar 4:2015:0504\u003c/li\u003e\n\u003cli\u003eKeane EM, Wilson H, McGrane D, Coakley D, Walsh JB. Use of solvents to disperse ear wax. BJCP. 1995;March/April,49(2):71-72.\u003c/li\u003e\n\u003cli\u003eChalishazar U, Williams H. Back to basics: finding an optimal cerumenolytic (earwax solvent). Br J Nurs. 2007;16(13):806-8. doi: 10.12968/bjon.2007.16.13.24247.\u003c/li\u003e\n\u003cli\u003eOron Y, Zwecker-Lazar I, Levy D, Kreitler S, Roth Y. Cerumen removal: comparison of cerumenolytic agents and effect on cognition among the elderly. Arch Gerontol Geriatr. 2011;52(2):228-32. doi: 10.1016/j.archger.2010.03.025.\u003c/li\u003e\n\u003cli\u003eClegg AJ. The safety and effectiveness of different methods of earwax removal: a systematic review and economic evaluation. Health Technol Assess. 2010;14(28):1-192. doi: 10.3310/hta14280.\u003c/li\u003e\n\u003cli\u003eCampbell MK, Piaggio G, Elbourne DR, Altman DG.Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.\u003c/li\u003e\n\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":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Earwax, Wax removal, Olive oil, Microsuction, Wax softener, Cerumenolytic","lastPublishedDoi":"10.21203/rs.3.rs-6394074/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6394074/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Excessive earwax causes unwanted symptoms such as hearing loss, tinnitus, discomfort and changes in the quality of one’s own voice. The NHS Audiology Wax Removal Service in North Wales recommends the use of olive oil as a pretreatment wax softener administered as either drops or spray prior to microsuction. For one in four patients microsuction is unsuccessful at the first attempt. Anecdotal evidence suggests that the administration of olive oil as a spray is a more effective pretreatment. This trial aims to explore whether administering olive oil pretreatment softener is more effective when administered as drops or spray.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e This two-arm cluster randomised control trial will be conducted within the existing NHS Audiology wax removal service in North Wales from January to July 2025. This pragmatic trial involves 26 NHS GP practices (clusters) and compares the administration methods of olive oil pretreatment via drops and spray. A sample size of 1,742 participants (67 in each of the 26 practices) was calculated as sufficient to determine a clinically significant difference. Presumed consent is used for all eligible patients seen within the wax removal service. Patients will be advised to source and self-administer three drops or sprays of olive oil for seven days before attending a wax removal microsuction appointment with an audiology practitioner where routine anonymized data will be collected. The primary outcome is whether wax removal is successful, as assessed via visual examination. The secondary outcomes include: improvements in self-reported symptoms, the amount of residual wax following microsuction and the number of adverse events. Statistical analyses will be conducted with an intention-to-treat design to compare outcomes between the groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e. This RCT aims to investigate whether administering olive oil as a pretreatment wax softener via drops or spray affects the outcome of wax removal. The outcome of this trial will inform future recommendations to patients and improve service effectiveness and efficiency by reducing the need for repeat visits. The results will be shared nationally and used to inform national guidance on wax removal.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration:\u003c/strong\u003e ISRCTN, ISRCTN28211073. Registered 23 December 2024, https://www.isrctn.com/ISRCTN28211073?q=earwax\u0026amp;filters=\u0026amp;sort=\u0026amp;offset=1\u0026amp;totalResults=3\u0026amp;page=1\u0026amp;pageSize=10\u003c/p\u003e","manuscriptTitle":"A comparison of the clinical effectiveness of pretreatment olive oil administered as drops versus spray prior to earwax removal by microsuction in adults: a protocol for a cluster randomised control trial.","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-14 11:30:29","doi":"10.21203/rs.3.rs-6394074/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2025-09-18T04:06:38+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2025-08-31T05:42:44+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-07-09T11:23:53+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Trials","date":"2025-06-12T14:20:46+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-05-12T11:10:05+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-04-07T08:09:13+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"0c968502-087a-44fe-8e18-3294dda388cd","owner":[],"postedDate":"July 14th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-12-22T16:02:46+00:00","versionOfRecord":{"articleIdentity":"rs-6394074","link":"https://doi.org/10.1186/s13063-025-09378-5","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2025-12-18 15:58:19","publishedOnDateReadable":"December 18th, 2025"},"versionCreatedAt":"2025-07-14 11:30:29","video":"","vorDoi":"10.1186/s13063-025-09378-5","vorDoiUrl":"https://doi.org/10.1186/s13063-025-09378-5","workflowStages":[]},"version":"v1","identity":"rs-6394074","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6394074","identity":"rs-6394074","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}