Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams (NCT04728503) | Clinical Trial Compass
CompletedNot Applicable
Brief Video-Based Mindful Movement Intervention Prior to Pelvic Exams
United States100 participantsStarted 2020-12-08
Plain-language summary
This study endeavors to implement a brief video-based mindfulness intervention within a clinic setting for women undergoing pelvic examinations, in hopes of reducing state anxiety and pain intensity during pelvic exams and improving overall exam satisfaction and likelihood to return for follow-up exams. This will be a pilot study will take place the University of Texas Southwestern (UTSW) Lowe Foundation Center for Women's Preventative Health Care. There will be a treatment and a control arm, estimated 50 women per group.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female
. Age of 18+ years
. Scheduled physical evaluation including pelvic exam at UT Southwestern's Lowe Foundation Center for Women's Preventative Health Care.
Exclusion criteria
. Participants who are unable to read, speak, write or understand verbally spoken English
. Participants who are blind or otherwise visually impaired will be excluded due to nature of video intervention.
. Participants who are pregnant will be excluded from the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analogue Scale - Anxiety 1 (Change in Anxiety)
Timeframe: baseline, pre-intervention/procedure
2
Visual Analogue Scale - Anxiety 2 (Change in Anxiety)
Timeframe: immediately after the intervention
3
Visual Analogue Scale - Anxiety 3 (Change in Anxiety)
Timeframe: immediately after the procedure
4
Visual Analogue Scale - Pain 1
Timeframe: baseline, pre-intervention
5
Visual Analogue Scale - Pain 2
Timeframe: immediately after the procedure
Trial details
NCT IDNCT04728503
SponsorUniversity of Texas Southwestern Medical Center