Ignite Creation Date:
2025-12-17 @ 2:48 PM
Ignite Modification Date:
2025-12-23 @ 9:49 PM
Study NCT ID:
NCT06999395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-31
First Post:
2025-05-09
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056650', 'term': 'Vulvodynia'}, {'id': 'D054515', 'term': 'Vulvar Vestibulitis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Collaborators and statistician.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'At 3, 6, and 9 weeks during intervention, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'Will be collected via an open text box suitable for narrative responses from participants.'}], 'primaryOutcomes': [{'measure': 'Sexual insertional pain', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': '0 (no pain) to 10 (extreme pain) rating for pain experienced during sexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).'}, {'measure': 'Nonsexual insertional pain', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': '0 (no pain) to 10 (extreme pain) rating for pain experienced during nonsexual activities involving vaginal insertion. Higher scores indicate higher pain intensity (worse outcomes).'}, {'measure': 'Provoked vulvar pain by pressure/contact', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': '0 (no pain) to 10 (extreme pain) rating for pain experienced during activities (sexual or nonsexual) involving pressure or contact to the vaginal opening. Higher scores indicate higher pain intensity (worse outcomes).'}, {'measure': 'Sexual function', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'Female Sexual Function Index. Range of scores is 2 to 36, with higher scores indicating better sexual function (better outcomes). A score of 26.55 and lower indicates possible sexual dysfunction.'}, {'measure': 'Pain interference on sexual life', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'The Sexual Function Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version will be used. Range of scores is 0-24, with higher scores indicating more interference (worse outcome).'}, {'measure': "Pain related interference on one's life", 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'The activity engagement subscale of the Chronic Pain Acceptance Questionnaire (range 0-66, higher scores indicate higher levels of acceptance, which suggest better outcomes) and the Life Interference subscale of the Vulvar Pain Assessment Questionnaire-Screening version (range 0-24, higher scores indicate more interference, which suggest worse outcomes) will be used.'}, {'measure': 'Participant global ratings of improvement', 'timeFrame': '12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'Scale of 0 (deterioration) to 5 (complete recovery) will be used. Range 0-5, with higher scores indicating more improvement.'}, {'measure': 'Treatment satisfaction', 'timeFrame': '12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'Scale of 0 (completely dissatisfied) to 10 (completely satisfied) will be used. Range of scores, 0-10, with higher scores indicating higher treatment satisfaction.'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'The Pain Catastrophizing Scale will be used. Total scores range from 0-52, with higher scores indicating higher catastrophizing (worse outcomes).'}, {'measure': 'Pain Self-efficacy', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'The Pain Self-Efficacy Scale will be used. Total scores range from 0-60, with higher scores indicating greater pain self-efficacy (better outcomes).'}, {'measure': 'Sexual distress', 'timeFrame': 'Baseline, 12 weeks (immediate post-treatment), 3-month follow-up', 'description': 'The 5 item Sexual Distress Scale will be used. Total scores range from 5-25, with higher scores indicating greater sexual distress (worse outcomes).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vulvodynia', 'provoked vestibulodynia', 'virtual pelvic health program', 'pain and sexual wellbeing outcomes', 'randomized controlled trial', 'intervention'], 'conditions': ['Vulvodynia (Chronic Vulvar Pain)', 'Vulvar Vestibulitis', 'Vestibulodynia', 'Provoked Vestibulodynia', 'Provoked Localized Vulvodynia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a 3-month online pelvic health program works to improve pain and sexual wellbeing in adult women with chronic genital pain. The main research questions it aims to answer are:\n\n* How well does the program work to improve pain and sexual wellbeing?\n* How well does the program work to improve pain anxiety and pain interference?\n* How do participants rate their improvement after completing the program?\n* How satisfied are participants with the program?\n\nResearchers will compare participants who receive the program right away to those who wait for the program. Participants who receive the program right away will\n\n* Progress through the program at their own pace\n* Learn about pain science, do pelvic health exercises, and use information to be more mindful and less anxious about the pain\n* Answer questions about their pain experiences and sexual wellbeing before and after the 3-month program, as well as 3 months after the end of the program\n* Provide information about their experiences with the program and progress through the program during and after the program', 'detailedDescription': 'The primary aim of the proposed single-centre randomized controlled trial is to examine the efficacy of a virtual multimodal 12-week program for individuals with provoked vestibulodynia (PVD, diagnosed by a healthcare provider) compared with a waitlist control group (i.e., participants who are on the waitlist to receive treatment). We hypothesize that participation in the program will result in greater improvements in our primary outcomes of pain and sexual wellbeing for persons with PVD immediately post-treatment and at 3-month follow-up compared to the control group. Our secondary aim is to compare outcomes of the program versus control group on secondary measures of pain catastrophizing, pain self-efficacy, interference (on sexual life and life in general), perceived improvement, and treatment satisfaction. We hypothesize that participants in the program will report greater improvements in these outcomes compared to participants on the waitlist . We will also collect information on adverse events, progress through the program, and thoughts about the program.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Self-reported physician diagnosis of provoked vestibulodynia (PVD)\n* PVD duration of at least 3 months\n* PVD pain intensity rating of at least 3 on a scale from 0 (no pain) to 10 (extreme pain)\n* Resides in North America (Canada or the United States)\n* Fluent in English\n\nExclusion Criteria:\n\n* Less than 18 years old\n* Pregnancy or suspected pregnancy\n* Breastfeeding\n* Up to one year postpartum\n* Physical or mental health conditions that significantly interfere with activities of daily living'}, 'identificationModule': {'nctId': 'NCT06999395', 'acronym': 'PVD', 'briefTitle': 'Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'QueensU-196214'}, 'secondaryIdInfos': [{'id': '196214', 'type': 'OTHER_GRANT', 'domain': 'Canadian Intitutes of Health Research'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment', 'description': 'Participants in the active treatment arm will receive access to the program once determined eligible.', 'interventionNames': ['Behavioral: Virtual online pelvic health program']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Participants in the waitlist control group will wait 3 months for access to the program. As the wait, they will receive the same surveys at the same timepoints as the active treatment group.'}], 'interventions': [{'name': 'Virtual online pelvic health program', 'type': 'BEHAVIORAL', 'description': 'The program offers a multimodal approach to self-guided treatment for PVD. Its multimodal approach is exemplified by pain education focusing on pelvic health and neuroplasticity to provide the foundation for strategies strengthening the mind-body connection to the pelvis; mindful breathing and relaxation exercises to reduce nervous system overactivation and enhance mood; and gradual progression of exercises encouraging awareness, stretching, and strengthening to promote relaxation of the pelvic floor muscles and reduction of accessory muscle tension resulting from protective guarding. The program uses 3 separate yet interconnected modules: Learn (20 modules of pain science education and skills), Rewire (11 modules featuring mindfulness and relaxation), and Move (45 pelvic and other exercises).', 'armGroupLabels': ['Active treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Research Coordinator', 'role': 'CONTACT', 'email': 'shrl@queensu.ca', 'phone': '613 533 3276'}, {'name': 'Post-doctoral fellow', 'role': 'CONTACT', 'email': 'shrl@queensu.ca', 'phone': '613 533 3276'}], 'overallOfficials': [{'name': 'Caroline Pukall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Caroline Pukall', 'investigatorAffiliation': "Queen's University"}}}}