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RecruitingNCT06141720Updated Sep 29, 2026

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

An interventional study of pain education and mindfulness of pain introduction and intervention in Endometriosis, Pain and Mindfulness, sponsored by Milton S. Hershey Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Endometriosis
  • Pain
  • Mindfulness
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

Exclusion Criteria:

  1. prior formal mindfulness training
  2. Unable to consent
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Standard of care for endometriosis surgery plus education

    Behavioral: pain education

  • Experimental
    Standard of care for endometriosis surgery plus mindfulness

    Behavioral: mindfulness of pain introduction and intervention

Interventions

  • Behavioralpain education

    Pain education

  • Behavioralmindfulness of pain introduction and intervention

    Brief mindfulness of pain introduction and intervention

05

What researchers measure

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

  5. Emotional functioning

    Hospital Anxiety and Depression Scale 0-21, 21 is worst

    Time frame: baseline

  6. Emotional functioning

    Hospital Anxiety and Depression Scale 0-21, 21 is worst

    Time frame: 1 week

  7. Emotional functioning

    Hospital Anxiety and Depression Scale 0-21, 21 is worst

    Time frame: 3 months

  8. Patient global impression of change

    Global Impression of change 1-7, 1 is best

    Time frame: 3 months

  9. Patient global impression of change

    Global Impression of change 1-7, 1 is best

    Time frame: 1 week

  10. Pain catastrophizing

    Pain catastrophizing Scale 0-52, 52 is worst

    Time frame: baseline

  11. Pain catastrophizing

    Pain catastrophizing Scale 0-52, 52 is worst

    Time frame: 1 week

  12. Pain catastrophizing

    Pain catastrophizing Scale 0-52, 52 is worst

    Time frame: 3 months

  13. Treatment satisfaction

    Treatment satisfaction 0-10, 10 being best

    Time frame: 1 week

  14. Treatment satisfaction

    Treatment satisfaction 0-10, 10 being best

    Time frame: 3 months

  15. Heart rate variability

    brief HRV assessment baseline and during intervention

    Time frame: baseline

Other outcomes

  1. Pain threshold

    Pain threshold

    Time frame: baseline

  2. Temporal summation

    Temporal summation of pain

    Time frame: baseline

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06141720
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Christa Coleman (Assistant Professor, Psychiatry and Behavioral Health, Milton S. Hershey Medical Center) — Principal investigator
First posted
Nov 21, 2023
Start date
May 30, 2024
Primary completion
Jun 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Christa Coleman
Contact
ccoleman3@pennstatehealth.psu.edu
717-531-8338
Christa Coleman
principal investigator · Penn State Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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