NCT06211231招募中不适用
MY-ENDO -- Mind Your ENDOmetriosis: a Digital Mindfulness- and Acceptance-based Endometriosis Self-management Program
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 255
- 试验地点
- 4
- 主要终点
- Quality of Life (QoL)
研究概览
简要总结
The purpose of the study is to assess the effect of a digital mindfulness- and acceptance-based psychological intervention on quality of life, work ability, pain experience and physical and mental health in participants experiencing chronic pain, fatigue and/or reduced quality of life due to endometriosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Only principal investigator is blinded, as neither participants nor care providers can be feasibly blinded, since both parties will know if a video consultation is provided or not. The study includes only patient-reported outcomes, hence, the outcome assessors are the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥18 years old.
- •Signed informed consent.
- •Endometriosis diagnosed by a gynecologist based on the medical case history, ultrasound, laparoscopy, or MRI (all self-reported).
- •Moderate to severe symptoms (pelvic pain and/or fatigue measured on an 11-point numeric rating scale (NRS) from 0 = no pain/fatigue to 10 = worst imaginable pain/fatigue symptom) or reduced endometriosis-related quality of life (measured by the EHP-30):
- •Moderate to severe endometriosis-related chronic pelvic pain (NRS > 2) or
- •Moderate to severe endometriosis-related fatigue (NRS > 2) or
- •Low endometriosis-related quality of life (one or more EHP-30 subscale mean scores ≥ 40.00).
- •Relevant clinical and/or surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis has been attempted.
- •Willingness to practice mindfulness and yoga at home for 30-45 minutes 5-7 days a week during the treatment period.
排除标准
- •Under 18 years old.
- •Severe psychiatric diagnosis made by a psychiatrist and/or ongoing psychiatric treatment.
- •Pregnancy or planned pregnancy during the study period.
- •An estimated lack of capacity or surplus energy to enter into a digital mindfulness treatment, for instance, because of:
- •major life events taking place at the same time (e.g., divorce, loss of a close relative, etc.)
- •linguistic or cultural barriers
结局指标
主要结局
Quality of Life (QoL)
时间窗: Change in Endometriosis Health Profile-30 from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization. Primary outcome comparison is between baseline and post-intervention (after session 10.)
QoL is measured using the Endometriosis Health Profile-30 scale, on a scale from 0 to 100, with higher scores indicating worse quality of life.
次要结局
- Quality of Life subdomains(Change in Quality of Life subdomains from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Pain and other endometriosis symptoms(Change in pain and other endometriosis symptoms from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Work ability(Change in Work Ability Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Pain acceptance(Change in Chronic Pain Acceptance Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Sleep quality(Change in Pittsburgh Sleep Quality Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Fatigue(Change in fatigue from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Wellbeing(Change in World Health Organization - Five Wellbeing Index from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Anxiety symptoms(Change in Generalized Anxiety Disorder Screener from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Depressive symptoms(Change in Beck's Depression Inventory from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Perceived stress(Change in Perceived Stress Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Psychological flexibility(Change in Acceptance and Action Questionnaire-II from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Pain catastrophizing(Change in Pain Catastrophizing Scale from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
- Mindfulness(Change in Five Facet Mindfulness Questionnaire from pre-randomization to after sessions 5 and 10, and 3, 6 and 12 months post-randomization.)
研究者
研究点 (4)
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