Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Milton S. Hershey Medical Center
Study ID
NCT06141720
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • pain education — BEHAVIORAL
    Pain education
  • mindfulness of pain introduction and intervention — BEHAVIORAL
    Brief mindfulness of pain introduction and intervention

Study Details

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.

Key Dates

Start date
May 30, 2024
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Standard of care for endometriosis surgery plus education
  • Experimental: Standard of care for endometriosis surgery plus mindfulness

Primary Outcome Measure

Use of opioid medication [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State HealthHersheyPennsylvania17033
Christa Coleman
[email protected]
7175318338

Find similar trials in Hershey, PA

By condition
Endometriosis
By specialty
Women's healthFertility
By research site
Penn State Health· Hershey, PA

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