Virtual Mindfulness and Endometriosis

Virtual Mindfulness-Based Therapy for the Management of Endometriosis Chronic Pelvic Pain: A Randomized Control Trial

Endometriosis is a common gynecologic disease affecting 5-10% of women during their reproductive years.1 Symptoms are variable but can include debilitating pelvic pain, pain with intercourse, menstrual cycles, bowel movements and urination. This can interfere with patients' ability to work, attend school or have intimate relationships leading to serious effects on quality of life and mental health.2-5 Current management of endometriosis is predominantly medical and surgical. Unfortunately, these medications can come with potent side effects that may be intolerable to some patients. They can also be prohibitively expensive for patients without prescription coverage. Mindfulness is a psychological approach to bring the mind to the present moment and to enhance self-awareness. It includes the use of emotional regulation, reduced reactivity, and enhanced response flexibility.6 Mindfulness-based psychological treatments have shown to improve both pain and quality of life in patients with chronic pelvic pain.7-9 Despite the evidence for mindfulness-based therapy there is still limited use of this in the treatment of pelvic pain. The reasons for this are multifactorial and include financial and accessibility barriers. Virtual platforms can help bridge these inequities and support marginalized patient populations in getting access to treatments for endometriosis pain. Virtual mindfulness resources have been shown to improve health and decrease stress, anxiety, and depression.10,11 There is minimal evidence about online mindfulness platforms for chronic pain and none relating to endometriosis. There is great potential to use this medium to overcome many barriers to access, but more research is needed on its effectiveness in treating endometriosis pain. The primary objective of this research study is to determine if virtual mindfulness-based therapy improves quality of life in patients with endometriosis following completion of the ten-week virtual mindfulness-based workshop.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Endometriosis
• Intervention / Treatment: Behavioral: 10-week mindfulness course

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen McCaffery, MD; Phone Number: 48119 416-867-7460; Email: Carmen.McCaffery@unityhealth.to
• Study Contact Backup: Name: Vahinie Narang, MD; Phone Number: 48119 416-867-7460; Email: Vahinie.narang@unityhealth.to

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be between the ages of 18 and 50; 2. Have been symptomatic for six months or greater; 3. Clinical or surgical diagnosis of endometriosis (must have at least one of the following): i) Documented Clinical Diagnosis of endometriosis based on symptoms ii) Previous endometriosis surgery confirmed by histopathology iii) Imaging suggestive of endometriosis (ultrasound or MRI) iv) Receiving standard medical treatment for endometriosis including combined oral contraceptives, progestin, GnRH agonists, GnRH antagonist.

Exclusion Criteria:

1. Diagnosis of other chronic pain condition, other than endometriosis;
2. Recent surgical cases (< 6 months)
3. Vulvar pain diagnosis including vulvodynia, vaginismus
4. Changes to current medical treatment or surgical intervention for endometriosis during the workshop period (10 weeks)
5. Inability to complete the survey package
6. Currently practicing mindfulness meditation.
7. Have used the MyEndo phone application previously
8. No internet access
9. Non-English speaking.
10. Unable to consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Mindfulness group; Participants will access the 10 week mindfulness course on the MyEndo App	Behavioral: 10-week mindfulness course; Participants will access the 10-week mindfulness course on the MyEndo App
No Intervention: The Control group; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EHP-30 Questionnaire	to determine if virtual mindfulness-based therapy improves quality of life in patients with endometriosis following completion of the ten-week virtual mindfulness-based workshop.	1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EHP-30 Questionnaire	To determine if virtual mindfulness therapy sustains improved quality of life in patients with endometriosis 6 months following completion of the intervention	1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up
Pain Medications Questionnaire	To determine if virtual mindfulness therapy decreases pain in patients with endometriosis	1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up
Pain Medications Questionnaire	To determine if virtual mindfulness therapy leads to a reduction in opiate pain medication use	1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up
Pain Medications Questionnaire	To determine if virtual mindfulness leads to a reduction in the quantity of pain modifiers used	1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; Endometriosis; Virtual Mindfulness
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Endometriosis
• Other Study ID Numbers: 25-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No