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Behavioral Intervention
PelvicSense Program for Vulvodynia
N/A
Recruiting
Led By Caroline Pukall, PhD
Research Sponsored by Dr. Caroline Pukall
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months after the end of the program
Awards & highlights
Study Summary
This trial will study if an online program helps reduce pain and other outcomes in those with provoked vestibulodynia. Participation will be remote & monitored for 3 months.
Who is the study for?
This trial is for adults over 18 who speak English and have been diagnosed with provoked vestibulodynia, a condition causing pain in the vulvar region, for at least three months. Participants will engage in an online program called PelvicSense and must continue their usual treatment during the study.Check my eligibility
What is being tested?
The effectiveness of PelvicSense, a 3-month online program designed to help manage pain and improve sexual outcomes for those suffering from provoked vestibulodynia, is being tested. The study includes assessments before starting, after completing the program, and three months later.See study design
What are the potential side effects?
Since this intervention involves an educational and therapeutic online program rather than medication or invasive procedures, traditional side effects are not expected. However, participants may experience varying levels of discomfort or emotional responses as they address sensitive topics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months after the end of the program
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months after the end of the program
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain intensity
Secondary outcome measures
Pain catastrophizing
Other outcome measures
Pain self-efficacy
Sexual distress
Trial Design
1Treatment groups
Experimental Treatment
Group I: 3 month PelvicSense(R) programExperimental Treatment1 Intervention
PelvicSense® is a home-based physiotherapy program integrating multiple techniques, including relaxation, breathing, stretching, strengthening and at-home manual therapy. This program also educates participants about the anatomy and physiology of the pelvis and teaches strategies to strengthen the mind-muscle connection to the pelvis.
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Who is running the clinical trial?
Dr. Caroline PukallLead Sponsor
1 Previous Clinical Trials
25 Total Patients Enrolled
Queen's UniversityLead Sponsor
366 Previous Clinical Trials
121,687 Total Patients Enrolled
Caroline Pukall, PhDPrincipal InvestigatorQueen's University
3 Previous Clinical Trials
95 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not fluent in English.My peripheral vascular disease has lasted less than 3 months.I am 18 years old or older.I have been diagnosed with peripheral vascular disease for at least 3 months.I am under 18 years old.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 3 month PelvicSense(R) program
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current enrollment count for this research endeavor?
"Correct. As evidenced by the information on clinicaltrials.gov, this medical experiment is actively searching for participants to join in. It was initially posted on February 25th 2021 and most recently updated June 8th 2021 with a need of 50 individuals from 1 site."
Answered by AI
Are researchers still accepting participants for this experiment?
"Clinicaltrials.gov indicates that this clinical trial is currently seeking suitable patients, having been put online on the 25th of February 2023 and updated most recently on June 8th of the same year."
Answered by AI
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