NCT06141720

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
May 2024Sep 2026

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

November 15, 2023

Last Update Submit

December 9, 2025

Conditions

PainEndometriosisMindfulness

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (15)

  • Sleep quality (sleep duration, awakenings, efficiency)

    1 week prior to surgery

  • Sleep quality (sleep duration, awakenings, efficiency)

    1 week following surgery

  • Sleep report

    1 week following surgery

  • Sleep report

    1 week prior to surgery

  • Emotional functioning

    baseline

  • +10 more secondary outcomes

Other Outcomes (2)

  • Pain threshold

    baseline

  • Temporal summation

    baseline

Study Arms (2)

Standard of care for endometriosis surgery plus education

ACTIVE COMPARATOR
Behavioral: pain education

Standard of care for endometriosis surgery plus mindfulness

EXPERIMENTAL
Behavioral: mindfulness of pain introduction and intervention

Interventions

pain educationBEHAVIORAL

Pain education

Standard of care for endometriosis surgery plus education
mindfulness of pain introduction and interventionBEHAVIORAL

Brief mindfulness of pain introduction and intervention

Standard of care for endometriosis surgery plus mindfulness

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years or older
  • diagnosis or probable diagnosis of endometriosis
  • candidate for surgical procedure for endometriosis
  • English speaking
  • have access to wifi and email

You may not qualify if:

  • prior formal mindfulness training
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Health

Hershey, Pennsylvania, 17033, United States

RECRUITING

MeSH Terms

Conditions

EndometriosisPain

Interventions

Methods

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Christa Coleman

    Penn State Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christa Coleman

CONTACT

717-531-8338ccoleman3@pennstatehealth.psu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Psychiatry and Behavioral Health

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

May 30, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)