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:
Queen's University
Organization:
Study Overview
Official Title:
Examining the Efficacy of a Multimodal Virtual Program on Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia: A Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PVD
Brief Summary:
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:
* How well does the program work to improve pain and sexual wellbeing?
* How well does the program work to improve pain anxiety and pain interference?
* How do participants rate their improvement after completing the program?
* How satisfied are participants with the program?
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
* Progress through the program at their own pace
* Learn about pain science, do pelvic health exercises, and use information to be more mindful and less anxious about the pain
* 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
* Provide information about their experiences with the program and progress through the program during and after the program
* How well does the program work to improve pain and sexual wellbeing?
* How well does the program work to improve pain anxiety and pain interference?
* How do participants rate their improvement after completing the program?
* How satisfied are participants with the program?
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
* Progress through the program at their own pace
* Learn about pain science, do pelvic health exercises, and use information to be more mindful and less anxious about the pain
* 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
* Provide information about their experiences with the program and progress through the program during and after the program
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 196214 | OTHER_GRANT | Canadian Intitutes of Health Research | View |