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Mindfulness for Endometriosis

N/A
Recruiting
Led By Christa Coleman
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Candidate for surgical procedure for endometriosis
Age 18 years or older
Must not have
Prior formal mindfulness training
Unable to consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a brief mindfulness-based intervention for women with endometriosis-related chronic pelvic pain who are undergoing surgical treatment. The study will enroll 10-20 adult participants with this condition

Who is the study for?
This trial is for adult women (18+) with a diagnosis or probable diagnosis of endometriosis who are about to undergo surgery for the condition. Participants must speak English and have access to wifi and email.
What is being tested?
The study tests a single-session mindfulness-based intervention before surgery, compared to usual care plus pain education. It aims to see if this approach is feasible, acceptable, and potentially helpful in improving post-surgical outcomes like stress coping and pain management.
What are the potential side effects?
Since the interventions involve non-invasive techniques such as mindfulness training and pain education, significant side effects are not anticipated. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for surgery to treat endometriosis.
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I am 18 years old or older.
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I have been diagnosed or likely have endometriosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have completed a mindfulness training program.
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I am unable to give consent by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain intensity
Use of opioid medication
Secondary study objectives
Emotional functioning
Pain catastrophizing
Patient global impression of change
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of care for endometriosis surgery plus mindfulnessExperimental Treatment1 Intervention
Group II: Standard of care for endometriosis surgery plus educationActive Control1 Intervention

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Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
511 Previous Clinical Trials
2,870,870 Total Patients Enrolled
Christa ColemanPrincipal InvestigatorPenn State Health
~0 spots leftby Dec 2024
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