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| ID | Type | Description | Link |
|---|---|---|---|
| 196214 | Other Grant/Funding Number | Canadian Intitutes of Health Research |
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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:
Researchers will compare participants who receive the program right away to those who wait for the program. Participants who receive the program right away will
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental | Participants in the active treatment arm will receive access to the program once determined eligible. |
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| Waitlist control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual online pelvic health program | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual insertional pain | 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). | Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Nonsexual insertional pain | 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). | Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Provoked vulvar pain by pressure/contact | 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). | Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Sexual function | 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. | Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Pain interference on sexual life | 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). | Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Pain related interference on one's life |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Catastrophizing | The Pain Catastrophizing Scale will be used. Total scores range from 0-52, with higher scores indicating higher catastrophizing (worse outcomes). | Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Pain Self-efficacy |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Will be collected via an open text box suitable for narrative responses from participants. | At 3, 6, and 9 weeks during intervention, 12 weeks (immediate post-treatment), 3-month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon Research Coordinator, MA | Contact | 613 533 3276 | qshrl@queensu.ca | |
| Marilyn Post-doctoral fellow, PhD | Contact | 613 533 3276 | qshrl@queensu.ca |
| Name | Affiliation | Role |
|---|---|---|
| Caroline Pukall, PhD | Queen's University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sexual Health Research Laboratory | Recruiting | Kingston | Ontario | K7L 3N6 | Canada |
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Collaborators and statistician.
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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.
| Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Participant global ratings of improvement | Scale of 0 (deterioration) to 5 (complete recovery) will be used. Range 0-5, with higher scores indicating more improvement. | 12 weeks (immediate post-treatment), 3-month follow-up |
| Treatment satisfaction | Scale of 0 (completely dissatisfied) to 10 (completely satisfied) will be used. Range of scores, 0-10, with higher scores indicating higher treatment satisfaction. | 12 weeks (immediate post-treatment), 3-month follow-up |
The Pain Self-Efficacy Scale will be used. Total scores range from 0-60, with higher scores indicating greater pain self-efficacy (better outcomes). |
| Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| Sexual distress | The 5 item Sexual Distress Scale will be used. Total scores range from 5-25, with higher scores indicating greater sexual distress (worse outcomes). | Baseline, 12 weeks (immediate post-treatment), 3-month follow-up |
| ID | Term |
|---|---|
| D056650 | Vulvodynia |
| D054515 | Vulvar Vestibulitis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014845 | Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014847 | Vulvitis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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