Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Study Overview
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Brief Summary
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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
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Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Conditions
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Endometriosis, Pain, Mindfulness

Intervention / Treatment
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* Behavioral: pain education
* Behavioral: mindfulness of pain introduction and intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older diagnosis or probable diagnosis of endometriosis candidate for surgical procedure for endometriosis English speaking have access to wifi and email Exclusion Criteria: prior formal mindfulness training Unable to consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care for endometriosis surgery plus education<br> | Behavioral: pain education<br>* Pain education<br>|
| Experimental: Standard of care for endometriosis surgery plus mindfulness<br> | Behavioral: mindfulness of pain introduction and intervention<br>* Brief mindfulness of pain introduction and intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of opioid medication | Morphine milligram equivalent following surgery | 1 week | 
| Use of opioid medication | Morphine milligram equivalent following surgery | 3 months | 
| Pain intensity | Numerical Pain Rating Scale 0-10, 10 being highest | 1 week | 
| Pain intensity | Numerical Pain Rating Scale 0-10, 10 being highest | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality (sleep duration, awakenings, efficiency) | actigraphy monitoring | 1 week prior to surgery | 
| Sleep quality (sleep duration, awakenings, efficiency) | actigraphy monitoring | 1 week following surgery | 
| Sleep report | sleep diary (hours slept, activities during day and night) | 1 week following surgery | 
| Sleep report | sleep diary (hours slept, activities during day and night) | 1 week prior to surgery | 
| Emotional functioning | Hospital Anxiety and Depression Scale 0-21, 21 is worst | baseline | 
| Emotional functioning | Hospital Anxiety and Depression Scale 0-21, 21 is worst | 1 week | 
| Emotional functioning | Hospital Anxiety and Depression Scale 0-21, 21 is worst | 3 months | 
| Patient global impression of change | Global Impression of change 1-7, 1 is best | 3 months | 
| Patient global impression of change | Global Impression of change 1-7, 1 is best | 1 week | 
| Pain catastrophizing | Pain catastrophizing Scale 0-52, 52 is worst | baseline | 
| Pain catastrophizing | Pain catastrophizing Scale 0-52, 52 is worst | 1 week | 
| Pain catastrophizing | Pain catastrophizing Scale 0-52, 52 is worst | 3 months | 
| Treatment satisfaction | Treatment satisfaction 0-10, 10 being best | 1 week | 
| Treatment satisfaction | Treatment satisfaction 0-10, 10 being best | 3 months |