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Clinical Trials/NCT06141720
NCT06141720
Recruiting
N/A

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Milton S. Hershey Medical Center1 site in 1 country20 target enrollmentMay 30, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Milton S. Hershey Medical Center
Enrollment
20
Locations
1
Primary Endpoint
Use of opioid medication
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2024
End Date
September 30, 2026
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christa Coleman

Assistant Professor, Psychiatry and Behavioral Health

Milton S. Hershey Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • prior formal mindfulness training
  • Unable to consent

Outcomes

Primary Outcomes

Use of opioid medication

Time Frame: 3 months

Morphine milligram equivalent following surgery

Pain intensity

Time Frame: 3 months

Numerical Pain Rating Scale 0-10, 10 being highest

Secondary Outcomes

  • Sleep quality (sleep duration, awakenings, efficiency)(1 week following surgery)
  • Sleep report(1 week prior to surgery)
  • Emotional functioning(3 months)
  • Patient global impression of change(1 week)
  • Pain catastrophizing(3 months)
  • Treatment satisfaction(3 months)
  • Heart rate variability(baseline)

Study Sites (1)

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