Endometriosis, Mindfulness, Pain
Conditions
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.
Interventions
BEHAVIORALpain education
Pain education
BEHAVIORALmindfulness of pain introduction and intervention
Brief mindfulness of pain introduction and intervention
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of opioid medication | 1 week | Morphine milligram equivalent following surgery |
| Pain intensity | 1 week | Numerical Pain Rating Scale 0-10, 10 being highest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality (sleep duration, awakenings, efficiency) | 1 week prior to surgery | actigraphy monitoring |
| Sleep report | 1 week following surgery | sleep diary (hours slept, activities during day and night) |
| Patient global impression of change | 3 months | Global Impression of change 1-7, 1 is best |
| Pain catastrophizing | baseline | Pain catastrophizing Scale 0-52, 52 is worst |
| Treatment satisfaction | 1 week | Treatment satisfaction 0-10, 10 being best |
| Emotional functioning | baseline | Hospital Anxiety and Depression Scale 0-21, 21 is worst |
| Heart rate variability | baseline | brief HRV assessment baseline and during intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain threshold | baseline | Pain threshold |
| Temporal summation | baseline | Temporal summation of pain |
Countries
United States
Contacts
Primary ContactChrista Coleman
Outcome results
None listed