Feasibility of a Mindfulness Intervention for Endometriosis Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Endometriosis; Mindfulness
• Intervention / Treatment: Behavioral: pain education; Behavioral: mindfulness of pain introduction and intervention

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christa Coleman; Phone Number: 717-531-8338; Email: ccoleman3@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Health
      • Contact: Christa Coleman; Phone Number: 7175318338; Email: ccoleman3@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care for endometriosis surgery plus education	Behavioral: pain education; Pain education
Experimental: Standard of care for endometriosis surgery plus mindfulness	Behavioral: mindfulness of pain introduction and intervention; Brief mindfulness of pain introduction and intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of opioid medication	Morphine milligram equivalent following surgery	1 week
Use of opioid medication	Morphine milligram equivalent following surgery	3 months
Pain intensity	Numerical Pain Rating Scale 0-10, 10 being highest	1 week
Pain intensity	Numerical Pain Rating Scale 0-10, 10 being highest	3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain threshold	Pain threshold	baseline
Temporal summation	Temporal summation of pain	baseline

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Christa Coleman, Penn State Health

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 15, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 9, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Endometriosis; Investigative Techniques; Methods
• Other Study ID Numbers: 23397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No