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Feasibility of a Mindfulness Intervention for Endometriosis Surgery

NCT ID: NCT06141720

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-30

Study Completion Date

2026-09-30

Brief Summary

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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

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Conditions

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Endometriosis Pain Mindfulness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of care for endometriosis surgery plus education

Group Type ACTIVE_COMPARATOR

pain education

Intervention Type BEHAVIORAL

Pain education

Standard of care for endometriosis surgery plus mindfulness

Group Type EXPERIMENTAL

mindfulness of pain introduction and intervention

Intervention Type BEHAVIORAL

Brief mindfulness of pain introduction and intervention

Interventions

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pain education

Pain education

Intervention Type BEHAVIORAL

mindfulness of pain introduction and intervention

Brief mindfulness of pain introduction and intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Christa Coleman

Assistant Professor, Psychiatry and Behavioral Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christa Coleman

Role: PRINCIPAL_INVESTIGATOR

Penn State Health

Locations

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Penn State Health

Hershey, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christa Coleman

Role: CONTACT

[email protected]
717-531-8338

Facility Contacts

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Christa Coleman

Role: primary

[email protected]
7175318338

Other Identifiers

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23397

Identifier Type: -

Identifier Source: org_study_id