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NCT04104542 · ClinicalTrials.gov registry record · NA
MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women
A NA study, sponsored by University of Missouri, Kansas City.
- Completed
- Registry status
- NA
- Development phase
- 41
- Enrollment target
NCT04104542: Completed NA study, sponsored by University of Missouri, Kansas City.
NCT04104542 is a NA study that has completed, run by University of Missouri, Kansas City. The registered enrollment target is 41 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04104542, a NA study, has completed, sponsored by University of Missouri, Kansas City.
- COMPLETED
- Registry status
- NA
- Development phase
- 41 participants
- Enrollment target
Study Summary
Subject Population: Active duty (AD) women with chronic pelvic pain (CPP) have different demands and stressors placed on them compared with their civilian counterparts. Due to a decrease in functionality from pain, not addressing these women's untreated CPP could be detrimental in readiness missions. With limited studies on AD women with CPP or sufficient treatments available, this study seeks to compare the effects on pain, depression, and inflammation in the mindfulness-based stress reduction (MBSR) group with a self-paced Healthy Lifestyle (HL) education control. Research Design: This randomized controlled trial will compare depression, pain, and biomarkers known for inflammation and pain in AD women with CPP pre-post an 8-week MBSR online intervention (n=55) with a self-directed Healthy Lifestyle control (n=55). Instruments: All participants will complete a demographic worksheet, Five Facets of Mindfulness Questionnaire (FFQ), a brief pain inventory (BPI), and a Patient Health Questionnaire (PHQ-9) pre-post intervention (MBSR or HL). Procedure: Participants will have 8-weeks of online training with voice-over slides in RedCap. The primary investigator will contact participants weekly for both groups and review diaries to help monitor fidelity and guide progress. Blood will be drawn for biomarkers for inflammation and pain and questionnaires will be completed pre-post intervention.
Primary Outcome
Brief Pain Inventory - Short Form (BPI-sf) is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on their daily functioning. The participant rates their worst, least, average, and current pain intensity, lists current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 p
Interventions
- BEHAVIORAL Healthy Lifestyle
- BEHAVIORAL Mindfulness based stress reduction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2019-06-01 |
| Est. Completion | 2019-10-31 |
| Phase | NA |
What the finished NCT04104542 record still lists
NCT04104542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Healthy Lifestyle is the first listed.
NCT04104542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04104542 about?
NCT04104542 is a clinical study titled "MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women". Subject Population: Active duty (AD) women with chronic pelvic pain (CPP) have different demands and stressors placed on them compared with their civilian counterparts. Due to a decrease in functionality from pain, not addressing these women's untreated CPP could be detrimental in readiness missions...
What is the current status of trial NCT04104542?
This trial is currently completed. It is a NA study. The enrollment target is 41 participants. The study started on 2019-06-01. Estimated completion is 2019-10-31.
What interventions are being tested in trial NCT04104542?
The interventions under investigation include: Healthy Lifestyle (BEHAVIORAL), Mindfulness based stress reduction (BEHAVIORAL).
Who is sponsoring clinical trial NCT04104542?
This trial is sponsored by University of Missouri, Kansas City, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04104542's enrollment target sits among peer trials
41 1446th of 2000 higher than 554 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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