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MOCHI: An RCT of Mindfulness as Treatment for Chronic Pelvic Pain in AD Women

NCT04104542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-07-12

No results posted yet for this 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.

Conditions

  • Chronic Pelvic Pain
  • Depression
  • Inflammation Pelvic

Interventions

BEHAVIORAL

Mindfulness based stress reduction

on-line training on the website = www.palousemindfulness.com

BEHAVIORAL

Healthy Lifestyle

Diet and Exercise

Sponsors & Collaborators

  • University of Missouri, Kansas City

    lead OTHER

Principal Investigators

  • Carol D Crisp, PhD (c) · University of Missouri, Kansas City

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-10-01
Completion
2019-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104542 on ClinicalTrials.gov