Virtual Mindfulness and Endometriosis
- Sponsor
- Unity Health Toronto
- Study ID
- NCT07501182
- Status
- Not Yet Recruiting
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Conditions
- Chronic Pain
- Endometriosis
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- 10-week mindfulness course — BEHAVIORALParticipants will access the 10-week mindfulness course on the MyEndo App
Study Details
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.
Key Dates
- First listed
- Mar 30, 2026
- Start date
- Mar 31, 2026
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 124 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: The Mindfulness groupParticipants will access the 10 week mindfulness course on the MyEndo App
- No Intervention: The Control groupStandard of Care
Primary Outcome Measure
EHP-30 Questionnaire [ Time Frame: 1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up ]
Central Contacts
- Carmen McCaffery, MD416-867-7460
- Vahinie Narang, MD416-867-7460
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