Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Not Applicable

Recruiting

• Conditions: Pain; Endometriosis; Mindfulness

• Registration Number: NCT06141720
• Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary

Endometriosis is a common cause of pelvic pain in women which has been historically under-studied and under-diagnosed. The goal of this research is to pilot-test the feasibility and acceptability of a manualized, single-session brief mindfulness-based intervention (BMBI) among participants with endometriosis-related chronic pelvic pain (ECPP) who undergo surgical treatment, and gather preliminary data necessary for future studies assessing BMBI's impact on outcomes in surgically-treated ECPP. This pilot study will enroll 10-20 adult participants with ECPP to receive either a BMBI adjunctive to treatment as usual (TAU; n=5-10) or education with TAU (n=5-10) prior to their ECPP surgery. The central hypothesis is the BMBI is feasible to deliver pre-operatively, acceptable to patients, and may help improve acute post-surgical outcomes through more adaptive stress coping and pain processing, enabled by mindfulness training.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-15
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-21
• Study Start: 2024-05-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. age 18 years or older
2. diagnosis or probable diagnosis of endometriosis
3. candidate for surgical procedure for endometriosis
4. English speaking
5. have access to wifi and email

Exclusion Criteria

1. prior formal mindfulness training
2. Unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Use of opioid medication	3 months	Morphine milligram equivalent following surgery
Pain intensity	3 months	Numerical Pain Rating Scale 0-10, 10 being highest

Secondary Outcome Measures

Name	Time	Method
Sleep quality (sleep duration, awakenings, efficiency)	1 week following surgery	actigraphy monitoring
Emotional functioning	3 months	Hospital Anxiety and Depression Scale 0-21, 21 is worst
Pain catastrophizing	3 months	Pain catastrophizing Scale 0-52, 52 is worst
Patient global impression of change	1 week	Global Impression of change 1-7, 1 is best
Treatment satisfaction	3 months	Treatment satisfaction 0-10, 10 being best
Sleep report	1 week prior to surgery	sleep diary (hours slept, activities during day and night)

Trial Locations

Locations (1)

Penn State Health; 🇺🇸 Hershey, Pennsylvania, United States