RECRUITING

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Quick Facts

Study Start:2024-05-30
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06141720

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. age 18 years or older
  2. 2. diagnosis or probable diagnosis of endometriosis
  3. 3. candidate for surgical procedure for endometriosis
  4. 4. English speaking
  5. 5. have access to wifi and email
  1. 1. prior formal mindfulness training
  2. 2. Unable to consent

Contacts and Locations

Study Contact

Christa Coleman
CONTACT
717-531-8338
ccoleman3@pennstatehealth.psu.edu

Principal Investigator

Christa Coleman
PRINCIPAL_INVESTIGATOR
Penn State Health

Study Locations (Sites)

Penn State Health
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Christa Coleman, PRINCIPAL_INVESTIGATOR, Penn State Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-30
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2024-05-30
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Endometriosis
  • Pain
  • Mindfulness