Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Pain Clinical Trial

Official title:

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141720
• Other study ID #: 23397
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: Milton S. Hershey Medical Center
• Contact: Christa Coleman
• Phone: 717-531-8338
• Email: ccoleman3[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis
• Mindfulness
• Pain

Intervention

Behavioral:
• pain education
Pain education
• mindfulness of pain introduction and intervention
Brief mindfulness of pain introduction and intervention

Locations

Country	Name	City	State
United States	Penn State Health	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of opioid medication	Morphine milligram equivalent following surgery	1 week
Primary	Use of opioid medication	Morphine milligram equivalent following surgery	3 months
Primary	Pain intensity	Numerical Pain Rating Scale 0-10, 10 being highest	1 week
Primary	Pain intensity	Numerical Pain Rating Scale 0-10, 10 being highest	3 months
Secondary	Sleep quality (sleep duration, awakenings, efficiency)	actigraphy monitoring	1 week prior to surgery
Secondary	Sleep quality (sleep duration, awakenings, efficiency)	actigraphy monitoring	1 week following surgery
Secondary	Sleep report	sleep diary (hours slept, activities during day and night)	1 week following surgery
Secondary	Sleep report	sleep diary (hours slept, activities during day and night)	1 week prior to surgery
Secondary	Emotional functioning	Hospital Anxiety and Depression Scale 0-21, 21 is worst	baseline
Secondary	Emotional functioning	Hospital Anxiety and Depression Scale 0-21, 21 is worst	1 week
Secondary	Emotional functioning	Hospital Anxiety and Depression Scale 0-21, 21 is worst	3 months
Secondary	Patient global impression of change	Global Impression of change 1-7, 1 is best	3 months
Secondary	Patient global impression of change	Global Impression of change 1-7, 1 is best	1 week
Secondary	Pain catastrophizing	Pain catastrophizing Scale 0-52, 52 is worst	baseline
Secondary	Pain catastrophizing	Pain catastrophizing Scale 0-52, 52 is worst	1 week
Secondary	Pain catastrophizing	Pain catastrophizing Scale 0-52, 52 is worst	3 months
Secondary	Treatment satisfaction	Treatment satisfaction 0-10, 10 being best	1 week
Secondary	Treatment satisfaction	Treatment satisfaction 0-10, 10 being best	3 months