About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 years or older
diagnosis or probable diagnosis of endometriosis
candidate for surgical procedure for endometriosis
English speaking
Disqualifiers
prior formal mindfulness training
Unable to consent
Trial design
Parallel
Treatments tested in this trial
pain education
BehavioralPain education
mindfulness of pain introduction and intervention
BehavioralBrief mindfulness of pain introduction and intervention
Treatment groups
Trial outcomes
Primary outcomes
Use of opioid medication
Morphine milligram equivalent following surgery
Use of opioid medication
Morphine milligram equivalent following surgery
Pain intensity
Numerical Pain Rating Scale 0-10, 10 being highest
Pain intensity
Numerical Pain Rating Scale 0-10, 10 being highest
Secondary outcomes
Sleep quality (sleep duration, awakenings, efficiency)
actigraphy monitoring
Sleep quality (sleep duration, awakenings, efficiency)
actigraphy monitoring
Sleep report
sleep diary (hours slept, activities during day and night)
Sleep report
sleep diary (hours slept, activities during day and night)
Other outcomes
Pain threshold
Pain threshold
Temporal summation
Temporal summation of pain
Sponsors and contacts
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