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NCT Number: NCT06141720

Feasibility of a Mindfulness Intervention for Endometriosis Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Health

Hershey, Pennsylvania, 17033, United States

Location status: Recruiting

Location contact

Christa Coleman

CONTACT

[email protected]

7175318338

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 years or older
  • diagnosis or probable diagnosis of endometriosis
  • candidate for surgical procedure for endometriosis
  • English speaking
  • have access to wifi and email

Exclusion criteria

  • prior formal mindfulness training
  • Unable to consent

Treatment and study plan

Pain education

Behavioral

Pain education

mindfulness of pain introduction and intervention

Behavioral

Brief mindfulness of pain introduction and intervention

Primary outcomes

  1. Use of opioid medication

    Time frame: 1 week

    Morphine milligram equivalent following surgery

  2. Use of opioid medication

    Time frame: 3 months

    Morphine milligram equivalent following surgery

  3. Pain intensity

    Time frame: 1 week

    Numerical Pain Rating Scale 0-10, 10 being highest

  4. Pain intensity

    Time frame: 3 months

    Numerical Pain Rating Scale 0-10, 10 being highest

Secondary outcomes

  1. Sleep quality (sleep duration, awakenings, efficiency)

    Time frame: 1 week prior to surgery

    actigraphy monitoring

  2. Sleep quality (sleep duration, awakenings, efficiency)

    Time frame: 1 week following surgery

    actigraphy monitoring

  3. Sleep report

    Time frame: 1 week following surgery

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

  4. Sleep report

    Time frame: 1 week prior to surgery

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

  5. Emotional functioning

    Time frame: baseline

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

  6. Emotional functioning

    Time frame: 1 week

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

  7. Emotional functioning

    Time frame: 3 months

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

  8. Patient global impression of change

    Time frame: 3 months

    Global Impression of change 1-7, 1 is best

  9. Patient global impression of change

    Time frame: 1 week

    Global Impression of change 1-7, 1 is best

  10. Pain catastrophizing

    Time frame: baseline

    Pain catastrophizing Scale 0-52, 52 is worst

  11. Pain catastrophizing

    Time frame: 1 week

    Pain catastrophizing Scale 0-52, 52 is worst

  12. Pain catastrophizing

    Time frame: 3 months

    Pain catastrophizing Scale 0-52, 52 is worst

  13. Treatment satisfaction

    Time frame: 1 week

    Treatment satisfaction 0-10, 10 being best

  14. Treatment satisfaction

    Time frame: 3 months

    Treatment satisfaction 0-10, 10 being best

  15. Heart rate variability

    Time frame: baseline

    brief HRV assessment baseline and during intervention

Other outcomes

  1. Pain threshold

    Time frame: baseline

    Pain threshold

  2. Temporal summation

    Time frame: baseline

    Temporal summation of pain

Study contacts

Contact information is provided by the study sponsor or research team.

Christa Coleman

CONTACT

[email protected]

717-531-8338

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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