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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
20
Pain education
Brief mindfulness of pain introduction and intervention
Penn State Health
Hershey, Pennsylvania, United States
RECRUITINGUse of opioid medication
Morphine milligram equivalent following surgery
Time frame: 1 week
Use of opioid medication
Morphine milligram equivalent following surgery
Time frame: 3 months
Pain intensity
Numerical Pain Rating Scale 0-10, 10 being highest
Time frame: 1 week
Pain intensity
Numerical Pain Rating Scale 0-10, 10 being highest
Time frame: 3 months
Sleep quality (sleep duration, awakenings, efficiency)
actigraphy monitoring
Time frame: 1 week prior to surgery
Sleep quality (sleep duration, awakenings, efficiency)
actigraphy monitoring
Time frame: 1 week following surgery
Sleep report
sleep diary (hours slept, activities during day and night)
Time frame: 1 week following surgery
Sleep report
sleep diary (hours slept, activities during day and night)
Time frame: 1 week prior to surgery
Emotional functioning
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Time frame: baseline
Emotional functioning
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Time frame: 1 week
Emotional functioning
Hospital Anxiety and Depression Scale 0-21, 21 is worst
Time frame: 3 months
Patient global impression of change
Global Impression of change 1-7, 1 is best
Time frame: 3 months
Patient global impression of change
Global Impression of change 1-7, 1 is best
Time frame: 1 week
Pain catastrophizing
Pain catastrophizing Scale 0-52, 52 is worst
Time frame: baseline
Pain catastrophizing
Pain catastrophizing Scale 0-52, 52 is worst
Time frame: 1 week
Pain catastrophizing
Pain catastrophizing Scale 0-52, 52 is worst
Time frame: 3 months
Treatment satisfaction
Treatment satisfaction 0-10, 10 being best
Time frame: 1 week
Treatment satisfaction
Treatment satisfaction 0-10, 10 being best
Time frame: 3 months
Heart rate variability
brief HRV assessment baseline and during intervention
Time frame: baseline
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