EndometriosisNCT05554497
Virtual Mindfulness for the Management of Endometriosis Pelvic Pain.
A study testing Mindfulness-based stress reduction curriculum in people with Endometriosis and Chronic Pain, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Endometriosis is a gynecologic condition that can cause severe pelvic pain and significantly impair quality of life. Endometriosis symptoms cannot always be controlled by medical therapy or surgery alone, indicating a need for the development of other adjunct treatments. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Chronic Pain
- What is being tested?
- Mindfulness-based stress reduction curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between the ages of 18 and 45;
- Have been symptomatic for six months or greater;
- 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;
- Vulvar pain diagnosis including vulvodynia, vaginismus
- Changes to current medical treatment or surgical intervention for endometriosis during the workshop period (8 weeks) which will be reviewed at the start of each workshop session;
- Inability to attend at least 6 out of the 8-sessions;
- Inability to complete the survey package before and after the total 8-session period;
- Prior mindfulness-based workshop participation or training;
Show all 10Show fewer
- Currently practicing mindfulness meditation.
- No internet access and microphone access: for the use of the zoom virtual platform and to enable participation in the workshops.
- Non-English speaking.
- Unable to consent.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Unity Health Toronto - St. Michael's Hospital
Toronto, Ontario, M5B 1W8
About this study
Official title: Virtual Mindfulness-based Therapy for the Management of Endometriosis Chronic Pelvic Pain: a Novel Delivery Platform to Increase Access to Care.
Endometriosis is a gynecologic condition that can cause severe pelvic pain and significantly impair quality of life. Endometriosis symptoms cannot always be controlled by medical therapy or surgery alone, indicating a need for the development of other adjunct treatments. Mindfulness is a non-medical treatment modality that has been used in the management of chronic pelvic pain.1-3 There is preliminary data to suggest that in-person mindfulness-based workshops can also improve endometriosis-related pain, but further research is needed.4-8 There are significant barriers to utilizing in-person mindfulness resources, the largest being cost and local availability of the workshop.
The objective of this pilot project is to assess the effectiveness of virtual mindfulness-based workshops to improve quality of life and pain in patients with endometriosis. The information from the workshops will then be used to create free online resources for patients to learn mindfulness-based approaches to manage endometriosis-related pelvic pain to reduce the financial and geographical barriers to access. Better access to mindfulness-based endometriosis management will enhance the treatment options for people suffering from this condition.
Read the detailed description
The objective of this pilot project is to assess the feasibility and effectiveness of virtual mindfulness-based workshops to improve quality of life and pain in patients with endometriosis. We hypothesize that virtual mindfulness-based stress reduction workshops will improve overall quality of life and decrease pain in patients with endometriosis and chronic pelvic pain. We also hypothesize that rates of narcotic pain medication use will decrease. We propose that the virtual platform will reduce some barriers to access mindfulness-based therapy.
A registered social worker with knowledge of gynecology clinic practice will create and run the virtual mindfulness workshops based on a standard mindfulness-based stress reduction curriculum. She will receive additional training in teaching mindfulness prior to the start of the study. The workshops will run weekly for eight-weeks over the Zoom platform. The sessions will last 2.5 hours and be held in the evening to ensure those with daytime commitments can participate.
For this pilot project a before and after study design will be employed. Participants will complete questionnaires before and after participation in the eight-week mindfulness workshop. Follow up questionnaires will be completed six and twelve months after completion of the workshop. The primary outcome for this study is an improvement in quality-of-life measures. Secondary outcomes are decrease in pain intensity, reduction in psychological stress, improvement in sexual function, reduction in quantity of pain modifiers used and reduction in opiate pain medication use. These main outcomes will be measured using a previously validated tool, The Endometriosis Health Profile Questionnaire (EHP-30).29 Additional tools to assess baseline demographics, barriers to accessing mindfulness and pain medication use have been created for this study. This project has been submitted to the St. Michael's Hospital research ethics board for approval.
Upon completion of the curriculum participants will be invited to a focus group to provide qualitative feedback on their experiences with mindfulness-based stress reduction, personal barriers to accessing this treatment, how it contributed to their overall treatment plan and types of activities they found mindfulness most useful for. This data will be coded by two members of the research team to look for themes and potential areas for improvements or change before proceeding with future workshops. It will also be used to inform future knowledge translation projects.
An initial 15 participants will be recruited to the study from the gynaecology clinics at St. Michael's hospital. This is a maximum group size suggested for an effective mindfulness workshop. The goal of this small group is to determine the feasibility and effectiveness of mindfulness-based therapy for endometriosis-related pelvic pain delivered in a virtual platform prior to completing a larger study.
- Conditions
- Endometriosis, Chronic Pain
- Being tested
- Mindfulness-based stress reduction curriculum
- Keywords
- Endometriosis, Chronic Pelvic Pain, 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.
Mindfulness-based stress reduction curriculumBehavioural
Standard 8-week mindfulness-based stress reduction curriculum
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness training | Experimental | 8 week virtual mindfulness-based stress reduction curriculum. Weekly 2.5 hour sessions over zoom. Receives: Behavioral: Mindfulness-based stress reduction curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endometriosis Health Profile Questionnaire (EHP-30)
Validated tool to measure symptoms of endometriosis and impact on quality of life.
Questions measured using scale: Never, Rarely, Sometimes, Often, Always. Never - never in pain or affected by it. Always - always in pain or affected by it.
Measured: Will be done before mindfulness curriculum then upon completion of the curriculum and 6 and 12 months after curriculum.
Secondary outcomes (1)
Change in Pain medication use
Questionnaire to measure pain medication use. Visual Analogue Scale.One extreme of the line represents "no pain at all" = 0, other represents "as much pain as you possibly imagine" = 10.
Specific questions asking type of medication use - yes/no, name, frequency responses in a specified time frame (ex. in last 1 month, or 6 months).
Measured: Will be done before mindfulness curriculum then upon completion of the curriculum and 6 and 12 months after curriculum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Feb 2021
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot project with a single arm to assess the effectiveness of a new platform to deliver a mindfulness curriculum.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554497
- Sponsor's protocol ID
- 20-285C
- Status last verified
- Dec 2023
- First submitted
- 28 Apr 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. 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 Novel Delivery Platform to Increase Access to Care.
- ClinicalTrials.gov ID
- NCT05554497
- Acronym / sponsor ID
- 20-285C
- Conditions
- Endometriosis, Chronic Pain
- Keywords
- Endometriosis, Chronic Pelvic Pain, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 26 Sep 2022 (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 gynecologic condition that can cause severe pelvic pain and significantly impair quality of life. Endometriosis symptoms cannot always be controlled by medical therapy or surgery alone, indicating a need for the development of other adjunct treatments. Mindfulness is a non-medical treatment modality that has been used in the management of chronic pelvic pain.1-3 There is preliminary data to suggest that in-person mindfulness-based workshops can also improve endometriosis-related pain, but further research is needed.4-8 There are significant barriers to utilizing in-person mindfulness resources, the largest being cost and local availability of the workshop.
The objective of this pilot project is to assess the effectiveness of virtual mindfulness-based workshops to improve quality of life and pain in patients with endometriosis. The information from the workshops will then be used to create free online resources for patients to learn mindfulness-based approaches to manage endometriosis-related pelvic pain to reduce the financial and geographical barriers to access. Better access to mindfulness-based endometriosis management will enhance the treatment options for people suffering from this condition.
Detailed description
The objective of this pilot project is to assess the feasibility and effectiveness of virtual mindfulness-based workshops to improve quality of life and pain in patients with endometriosis. We hypothesize that virtual mindfulness-based stress reduction workshops will improve overall quality of life and decrease pain in patients with endometriosis and chronic pelvic pain. We also hypothesize that rates of narcotic pain medication use will decrease. We propose that the virtual platform will reduce some barriers to access mindfulness-based therapy.
A registered social worker with knowledge of gynecology clinic practice will create and run the virtual mindfulness workshops based on a standard mindfulness-based stress reduction curriculum. She will receive additional training in teaching mindfulness prior to the start of the study. The workshops will run weekly for eight-weeks over the Zoom platform. The sessions will last 2.5 hours and be held in the evening to ensure those with daytime commitments can participate.
For this pilot project a before and after study design will be employed. Participants will complete questionnaires before and after participation in the eight-week mindfulness workshop. Follow up questionnaires will be completed six and twelve months after completion of the workshop. The primary outcome for this study is an improvement in quality-of-life measures. Secondary outcomes are decrease in pain intensity, reduction in psychological stress, improvement in sexual function, reduction in quantity of pain modifiers used and reduction in opiate pain medication use. These main outcomes will be measured using a previously validated tool, The Endometriosis Health Profile Questionnaire (EHP-30).29 Additional tools to assess baseline demographics, barriers to accessing mindfulness and pain medication use have been created for this study. This project has been submitted to the St. Michael's Hospital research ethics board for approval.
Upon completion of the curriculum participants will be invited to a focus group to provide qualitative feedback on their experiences with mindfulness-based stress reduction, personal barriers to accessing this treatment, how it contributed to their overall treatment plan and types of activities they found mindfulness most useful for. This data will be coded by two members of the research team to look for themes and potential areas for improvements or change before proceeding with future workshops. It will also be used to inform future knowledge translation projects.
An initial 15 participants will be recruited to the study from the gynaecology clinics at St. Michael's hospital. This is a maximum group size suggested for an effective mindfulness workshop. The goal of this small group is to determine the feasibility and effectiveness of mindfulness-based therapy for endometriosis-related pelvic pain delivered in a virtual platform prior to completing a larger study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot project with a single arm to assess the effectiveness of a new platform to deliver a mindfulness curriculum.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training | Experimental | Behavioral: Mindfulness-based stress reduction curriculum8 week virtual mindfulness-based stress reduction curriculum. Weekly 2.5 hour sessions over zoom. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be between the ages of 18 and 45;
- Have been symptomatic for six months or greater;
- 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
Key exclusion criteria (10 listed)
- Diagnosis of other chronic pain condition, other than endometriosis;
- Vulvar pain diagnosis including vulvodynia, vaginismus
- Changes to current medical treatment or surgical intervention for endometriosis during the workshop period (8 weeks) which will be reviewed at the start of each workshop session;
- Inability to attend at least 6 out of the 8-sessions;
- Inability to complete the survey package before and after the total 8-session period;
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 |
|---|---|---|
| Mindfulness-based stress reduction curriculumStandard 8-week mindfulness-based stress reduction curriculum | Behavioural | Mindfulness training |
Primary outcome
Change in Endometriosis Health Profile Questionnaire (EHP-30)
Time frame: Will be done before mindfulness curriculum then upon completion of the curriculum and 6 and 12 months after curriculum.
Validated tool to measure symptoms of endometriosis and impact on quality of life. Questions measured using scale: Never, Rarely, Sometimes, Often, Always. Never - never in pain or affected by it. Always - always in pain or affected by it.
1 secondary outcome
Change in Pain medication use
Time frame: Will be done before mindfulness curriculum then upon completion of the curriculum and 6 and 12 months after curriculum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction curriculum in people with Endometriosis and Chronic Pain, run by Unity Health Toronto at 1 site in Canada.
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 7 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: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endometriosis Health Profile Questionnaire (EHP-30) (time frame: Will be done before mindfulness curriculum then upon completion of the curriculum and 6 and 12 months after curriculum.). 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 12 Dec 2023.