Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Premenstrual Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- PMS-Impact Questionnaire (PMS-I)
研究概览
简要总结
This pilot study explored the effectiveness and acceptance of a digital app for the self-management of PMS. A total of 175 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on PMS-specific symptoms and broader health aspects such as fatigue and emotional well-being. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.
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
- Double (Care Provider, Investigator)
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
- •Legal capacity
- •Residency in Germany
- •Female gender
- •Age ≥18 years
- •Diagnosed and medically confirmed current PMS (N94.3)
- •Ownership of a smartphone and ability to use it
- •Internet access for app usage and questionnaire completion
- •Email address for registration
- •Willingness to complete questionnaires online
- •Motivation for regular app usage
- •Sufficient proficiency in the German language
排除标准
- •Pregnancy, breastfeeding, or the onset of menopause during the study period
- •Changes in hormonal therapy and/or use of antidepressants within eight weeks prior to the study start and/or planned in the upcoming 12 weeks
- •Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
- •Current participation in other clinical studies
- •Failure to meet the inclusion criteria
研究组 & 干预措施
Care-as-usual
Control group has access to care-as-usual only
Care-as-usual + digital PMS app
The intervention group has access to the PMS app and its functions in in addition to care-as-usual
干预措施: PMS App (Device)
结局指标
主要结局
PMS-Impact Questionnaire (PMS-I)
时间窗: 12 weeks
PMS-specific impairments, min = 18 and max=72, higher scores indicate a worse outcome
次要结局
未报告次要终点