EndometriosisNCT07501182
Virtual Mindfulness and Endometriosis
A study testing 10-week mindfulness course in people with Endometriosis and Chronic Pain, run by Unity Health Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Chronic Pain
- What is being tested?
- 10-week mindfulness course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Have used the MyEndo phone application previously
- No internet access
- Non-English speaking.
- Unable to consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Endometriosis, Chronic Pain
- Being tested
- 10-week mindfulness course
- Keywords
- Endometriosis, Chronic Pain, Virtual Mindfulness
- Medical subject headings
- Endometriosis, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-week mindfulness courseBehavioural
Participants will access the 10-week mindfulness course on the MyEndo App
| Study group | Role | What they receive |
|---|---|---|
| The Mindfulness group | Experimental | Participants will access the 10 week mindfulness course on the MyEndo App Receives: Behavioral: 10-week mindfulness course |
| The Control group | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To determine if virtual mindfulness therapy sustains improved quality of life in patients with endometriosis 6 months following completion of the intervention
Measured: 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
Measured: 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
Measured: 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
Measured: 1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501182
- Sponsor's protocol ID
- 25-201
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Mindfulness-Based Therapy for the Management of Endometriosis Chronic Pelvic Pain: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07501182
- Acronym / sponsor ID
- 25-201
- Conditions
- Endometriosis, Chronic Pain
- Keywords
- Endometriosis, Chronic Pain, Virtual Mindfulness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Mindfulness group | Experimental | Behavioral: 10-week mindfulness courseParticipants will access the 10 week mindfulness course on the MyEndo App |
| The Control group | No intervention | –Standard of Care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-week mindfulness courseParticipants will access the 10-week mindfulness course on the MyEndo App | Behavioural | The Mindfulness group |
Primary outcome
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
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.
4 secondary outcomes
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
Pain Medications 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
Pain Medications 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
Pain Medications 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing 10-week mindfulness course in people with Endometriosis and Chronic Pain, run by Unity Health Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen McCaffery, MD (416-867-7460 ext. 48119, Carmen.McCaffery@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.