Pilot Study to Investigate the Influence of a Dysmenorrhoea App on the Quality of Life and Symptoms of Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
The pilot study investigates the influence of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. The intervention group can use the app over the study period of 12 weeks in addition to usual care, while the control group only receives the usual standard care. The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 100-200 participants.
详细描述
The pilot study aims to investigate the effect of a dysmenorrhoea app on the quality of life and symptoms of women with dysmenorrhoea. Dysmenorrhoea, defined as painful menstruation, is a widespread and distressing health problem that can significantly affect the quality of life and well-being of affected women. Research into digital health applications has shown the potential to provide innovative solutions to improve care and self-management of chronic conditions.
The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the dysmenorrhoea app over a 12-week period in addition to usual care (intervention group) or only usual care as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints, which were completed at T0 (baseline) and after 4 (T1), 8 (T2) and 12 weeks (T3).
The DSI, MDQ, VAS pain, FSS, FESS, PDI and DASS-21 questionnaires are defined as endpoints. The difference between the intervention group and the control group is compared in terms of the changes (change score) between the time points T0 (baseline) and T3 (post-treatment: twelve weeks). The aim was to show the superiority of the intervention. The evaluation was carried out additionally at the time points T0 and T1 (4 weeks after the start of the study) and T0 and T2 (8 weeks after the start of the study).
The hypotheses for the individual endpoints are defined as follows, whereby the respective hypothesis is to be analysed using an ANCOVA with baseline values as covariates:
Null hypothesis (H0): There is no difference between the intervention group and the control group.
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 (Investigator, Outcomes Assessor)
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
- •Resident in Germany
- •Age ≥18 years of age
- •Known and medically confirmed dysmenorrhoea
- •Ownership of an internet-enabled mobile phone and ability to use it
- •Internet access for the app application and questionnaire
- •Answering email address for registration
- •Willingness to complete questionnaires online
- •Motivation to use the app regularly
- •Sufficient knowledge of the German language
- •Absence of
排除标准
- •Exclusion Criteria:
- •Pregnancy existing at the time of interview
- •Gynaecological abdominal surgery planned in the next 12 weeks or gynaecological abdominal surgery performed within the last 8 weeks before study start
- •Previous or existing access to the Endo app or other comparable digital health applications or current active prescription
- •Current participation in other clinical studies
- •Non-compliance with inclusion criteria
研究组 & 干预措施
Control group
the intervention group has access to normal regular care only.
Intervention group
the intervention group has access to the dysmenorrhoea app and its functions in addition to normal regular care.
干预措施: Pia-App (Device)
结局指标
主要结局
Visual analog scale (VAS)
时间窗: 12 weeks
Questionnaire
Depression Anxiety Stress Scale mit 21 Items (DASS-21)
时间窗: 12 weeks
Questionnaire
German Version of Pain Self-Efficacy Questionnaire (FESS)
时间窗: 12 weeks
Questionnaire
Fatigue Severity Scale (FSS)
时间窗: 12 weeks
Questionnaire
Pain Disability Index (PDI)
时间窗: 12 weeks
Questionnaire
Dysmenorrhea Symptom Interference Scale (DSI)
时间窗: 12 weeks
Questionnaire
Moos Menstrual Distress Questionnaire, Form C (MDQ)
时间窗: 12 weeks
Questionnaire
次要结局
未报告次要终点