Virtual Mindfulness and Endometriosis

NCT07501182 | Not Yet Recruiting

• 1 other identifier: 25-201
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Endometriosis; Chronic Pain

Keywords

Endometriosis; Chronic Pain; Virtual Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• EHP-30 Questionnaire

  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

  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

  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

  1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up

Study Arms (2)

The Mindfulness group

EXPERIMENTAL

Participants will access the 10 week mindfulness course on the MyEndo App

Behavioral: 10-week mindfulness course

The Control group

NO INTERVENTION

Standard of Care

Interventions

10-week mindfulness course BEHAVIORAL

Participants will access the 10-week mindfulness course on the MyEndo App

The Mindfulness group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Unity Health Toronto: lead

MeSH Terms

Conditions

Endometriosis; Chronic Pain

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carmen McCaffery, MD

CONTACT

416-867-7460; Carmen.McCaffery@unityhealth.to

Vahinie Narang, MD

CONTACT

416-867-7460; Vahinie.narang@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share