Virtual Mindfulness for the Management of Endometriosis Pelvic Pain.
Condition: Endometriosis; Chronic Pain
MeSH terms: Endometriosis; Chronic Pain; Pelvic Pain
Study type: Interventional

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.
    

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.
    

Intervention name(s): Mindfulness-based stress reduction curriculum
Intervention type(s): Behavioral
Intervention description(s): Standard 8-week mindfulness-based stress reduction curriculum
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Endometriosis; Chronic Pelvic Pain; Mindfulness