Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Penn State Health

Status: Enrolling

Conditions: Mindfulness; Endometriosis; Pain

Treatments: Behavioral: pain education; Behavioral: mindfulness of pain introduction and intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06141720

23397

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Standard of care for endometriosis surgery plus education

Active Comparator group

Treatment:

Behavioral: pain education

Standard of care for endometriosis surgery plus mindfulness

Experimental group

Treatment:

Behavioral: mindfulness of pain introduction and intervention