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Feasibility of a Mindfulness Intervention for Endometriosis Surgery

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jun 30, 2026 → Jun 30, 2027
See other at-risk trials from Milton S. Hershey Medical Center

Record History

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  1. Primary completion pushed from Jun 30, 2026 to Jun 30, 2027
    • Study completion pushed from Sep 30, 2026 to Sep 30, 2027
    • Eligibility criteria expanded, about 7 words
  2. Primary completion date: Dec 31, 2025 to Jun 30, 2026
    • Study completion date: Feb 28, 2026 to Sep 30, 2026
    • Secondary endpoints: 14 to 15
    • Site contact updated
    v7
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2025
    • Study completion date: Feb 28, 2025 to Feb 28, 2026
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 1, 2024 to May 30, 2024
    v5
  5. Start date: Apr 1, 2024 to Jun 1, 2024v4
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  1. Start date: Jan 1, 2024 to Apr 1, 2024v3
  2. Secondary endpoints: 16 to 14v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06141720
Lead Sponsor Milton S. Hershey Medical Center
Conditions
(from sponsor)		 Endometriosis, Pain, Mindfulness
Related terms Endometriosis, Pain
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov