Feasibility of a Mindfulness Intervention for Endometriosis Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMilton S. Hershey Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • pain education

    Behavioral

    Pain education

  • mindfulness of pain introduction and intervention

    Behavioral

    Brief mindfulness of pain introduction and intervention

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Standard of care for endometriosis surgery plus educationActive comparator 1 intervention
Group B: Standard of care for endometriosis surgery plus mindfulnessExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Use of opioid medication

Morphine milligram equivalent following surgery

Time frame
1 week
2

Use of opioid medication

Morphine milligram equivalent following surgery

Time frame
3 months
3

Pain intensity

Numerical Pain Rating Scale 0-10, 10 being highest

Time frame
1 week
4

Pain intensity

Numerical Pain Rating Scale 0-10, 10 being highest

Time frame
3 months

Secondary outcomes

1

Sleep quality (sleep duration, awakenings, efficiency)

actigraphy monitoring

Time frame
1 week prior to surgery
2

Sleep quality (sleep duration, awakenings, efficiency)

actigraphy monitoring

Time frame
1 week following surgery
3

Sleep report

sleep diary (hours slept, activities during day and night)

Time frame
1 week following surgery
4

Sleep report

sleep diary (hours slept, activities during day and night)

Time frame
1 week prior to surgery

Other outcomes

1

Pain threshold

Pain threshold

Time frame
baseline
2

Temporal summation

Temporal summation of pain

Time frame
baseline

Sponsors and contacts

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