Evaluation of Easy-to-Implement Intervention for Menstrual Pain in a Series of N-of-1 Trials: Study Protocol of the Menstrual Pain Intervention Among Students Study (MPIS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- Daily Perceived Menstrual Pain
研究概览
简要总结
Dysmenorrhea, or menstrual pain, is a prevalent issue among female students, which negatively influences students' productivity, academic performance, and quality of life.
This study explores a non-pharmaceutical physiotherapy method that has shown potential to decrease menstrual cramping, but research on its efficacy remains limited. The intervention is a visceral abdominal self-massage.
Because individuals tend to respond differently to physiotherapy methods, the investigators aim to assess the effect of performing the self-massage regularly on the self-reported perception of menstrual pain and related symptoms of female students in Germany, with a series of N-of-1 trials.
N-of-1 trials lasting up to 60 days are conducted with participants who regularly experience dysmenorrhea. Participants undergo a control (A) and an intervention phase (B), with a probable second control phase (A) depending on the individual cycle lengths and study start. Daily symptoms are recorded via the StudyU smartphone application. The baseline questionnaire collects demographic, lifestyle, and menstrual history information to identify potential effect modifiers. The intervention's effects will be estimated across individual and population levels. Participants will receive access to an analysis of their data.
The results may benefit individual well-being and contribute to the exploration of a more holistic approach to menstrual health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female students living in Germany
- •Have consistently experienced menstrual pain and other symptoms primarily during menstruation for at least the last three cycles
- •Regular access to a smartphone on which the StudyU (https://www.studyu.health/) application can be installed
- •Informed consent
- •Proficiency in English or German
排除标准
- •Age under 18 or over 45 years
- •Participation in a different intervention study during the duration of this study
- •Use of hormonal treatments affecting the menstrual cycle
- •Confirmed or suspected pregnancy
- •Presence of contraindicated disorders or diseases for massage
- •Severe psychiatric conditions impairing informed consent or reliable participation
- •Substance abuse (e.g., alcohol, drugs)
- •Planned surgery within the next four to five months
- •Doctor's advice against proceeding with the intervention
结局指标
主要结局
Daily Perceived Menstrual Pain
时间窗: Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days
Participants assess the severity of menstrual pain on a visual analog scale from 0 to 10 (0=no pain, 10=worst pain imaginable).
次要结局
- Pain Medication Intake(Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days)
- Additional Menstrual Symptoms(Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days)
- Mood Impact(Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days)
- Symptom Narrative(Daily from date of enrollment until completion of individual N-of-1 trial, up to 60 days)
研究者
Stefan Konigorski
Dr. rer. nat.
University of Potsdam