NCT06141720 Feasibility of a Mindfulness Intervention for Endometriosis Surgery
| NCT ID | NCT06141720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Milton S. Hershey Medical Center |
| Condition | Endometriosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-05-30 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-05-30 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Christa Coleman
PRINCIPAL INVESTIGATOR
Penn State Health
Frequently Asked Questions
Who can join the NCT06141720 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometriosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06141720 currently recruiting?
Yes, NCT06141720 is actively recruiting participants. Contact the research team at ccoleman3@pennstatehealth.psu.edu for enrollment information.
Where is the NCT06141720 trial being conducted?
This trial is being conducted at Hershey, United States.
Who is sponsoring the NCT06141720 clinical trial?
NCT06141720 is sponsored by Milton S. Hershey Medical Center. The principal investigator is Christa Coleman at Penn State Health. The trial plans to enroll 20 participants.