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Virtual Mindfulness and Endometriosis

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07501182
Enrollment
124
Registered
2026-03-30
Start date
2026-03-01
Completion date
2027-12-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Endometriosis

Keywords

Endometriosis, Chronic Pain, Virtual Mindfulness

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.

Interventions

BEHAVIORAL10-week mindfulness course

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

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
EHP-30 Questionnaire1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-upto determine if virtual mindfulness-based therapy improves quality of life in patients with endometriosis following completion of the ten-week virtual mindfulness-based workshop.

Secondary

MeasureTime frameDescription
EHP-30 Questionnaire1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-upTo determine if virtual mindfulness therapy sustains improved quality of life in patients with endometriosis 6 months following completion of the intervention
Pain Medications Questionnaire1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-upTo determine if virtual mindfulness therapy decreases pain in patients with endometriosis

Contacts

CONTACTCarmen McCaffery, MD
Carmen.McCaffery@unityhealth.to416-867-7460
CONTACTVahinie Narang, MD
Vahinie.narang@unityhealth.to416-867-7460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026