NCT06821217招募中不适用
A Mobile Application as Supportive Treatment of Endometriosis: the Effect on Quality of Life and Endometriosis-associated Pain. A Randomized Controlled Trial.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Life quality
研究概览
简要总结
The goal of this clinical trial is to learn if an App-based intervention affects the quality of life in patients with suspected or confirmed endometriosis. The main questions it aims to answer are:
- Does the App-based intervention improve the quality of life?
- Does it lead to pain relief? Researchers will compare participants using the App to a control group to see if the App works to improve quality of life and endometriosis-related symptoms.
Participants will:
- Use an App-based intervention or be in the control group (no App-use) for 6 months
- Visit or have a telephone consultation after 3 and 6 months
- Complete a questionnaire to assess the quality of life at inclusion, after 1, 3 and 6 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Informed Consent as documented by signature
- •Age 18 or older
- •Premenopausal status (menopause is defined as amenorrhea lasting one year or longer)
- •Endometriosis, confirmed by surgery or clinically suspected
- •Possession of a smartphone
排除标准
- •Planned endometriosis surgery or planned hormonal therapy in the study period
- •Surgery and/or new hormonal therapy in the last three months
- •Malignant diseases
- •Pregnancy
- •Breastfeeding
- •Active desire for pregnancy in the study period
- •Fertility treatment
- •Simultaneous participation in other intervention studies
研究组 & 干预措施
Control group with clinically suspected endometriosis
No Intervention
Intervention group with histologically confirmed endometriosis
Experimental
干预措施: NALU Endo Flow App (Device)
Control group with histologically confirmed endometriosis
No Intervention
Intervention group with clinically suspected endometriosis
Experimental
干预措施: NALU Endo Flow App (Device)
结局指标
主要结局
Life quality
时间窗: 6 months
The primary endpoint will be the change in quality of life in App users assessed by the EHP-30 questionnaire (Endometriosis-Health-Profile-Questionnaire: The questions can be divided into five subscales covering 'pain', 'control and powerlessness', 'social support', 'emotional wellbeing' and 'self-image'. The questionnaire is standardized on a scale from 0 to 100, with lower scores indicating better quality of life.
次要结局
- Pain relief(6 months)
研究者
研究点 (1)
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