Recruiting

Mindfulness Intervention

Sponsor:

Milton S. Hershey Medical Center

Code:

NCT06141720

Conditions

Endometriosis

Pain

Mindfulness

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pain education

mindfulness of pain introduction and intervention

Study Details

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.

Conditions

Endometriosis

Pain

Mindfulness

Study ID

NCT06141720

Start date

May 30, 2024

Status verified date

Dec, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Standard of care for endometriosis surgery plus education

experimental: Standard of care for endometriosis surgery plus mindfulness

Interventions

pain education

Pain education

mindfulness of pain introduction and intervention

Brief mindfulness of pain introduction and intervention

Primary outcome measure

  • Use of opioid medication [ Time Frame: 1 week ]
  • Use of opioid medication [ Time Frame: 3 months ]
  • Pain intensity [ Time Frame: 1 week ]
  • Pain intensity [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Penn State Health

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

More Information

Sponsor

Milton S. Hershey Medical Center

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Milton S. Hershey Medical Center on 2025-12-17.