Virtual Mindfulness and Endometriosis

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• EHP-30 Questionnaire [Срок оценки: 1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up]

Вторичные конечные точки (4)

• EHP-30 Questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 1 week before the intervention starts (pre-intervention) and 1 week following the completion of intervention (post-intervention); Readministered at 6-month follow-up]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.
• Have used the MyEndo phone application previously
• No internet access
• Non-English speaking.
• Unable to consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07501182 · 25-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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