Virtual Mindfulness for the Management of Endometriosis Pelvic Pain.

NCT05554497 | Completed

• 1 other identifier: 20-285C
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Endometriosis; Chronic Pain

Keywords

Endometriosis; Chronic Pelvic Pain; Mindfulness

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Will be done before mindfulness curriculum then upon completion of the curriculum and 6 and 12 months after curriculum.

Study Arms (1)

Mindfulness training

EXPERIMENTAL

8 week virtual mindfulness-based stress reduction curriculum. Weekly 2.5 hour sessions over zoom.

Behavioral: Mindfulness-based stress reduction curriculum

Interventions

Mindfulness-based stress reduction curriculum BEHAVIORAL

Standard 8-week mindfulness-based stress reduction curriculum

Mindfulness training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Patients assigned female at birth are eligible to participate, current gender identity does not effect eligibility.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

Unity Health Toronto - St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot project with a single arm to assess the effectiveness of a new platform to deliver a mindfulness curriculum.

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: September 26, 2022
• Study Start: February 1, 2021
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

CA (1)