Efficacy of Rhythmical Massage in Comparison to Heart Rate Variability Biofeedback in Women With Primary Dysmenorrhea - a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean pain intensity during menstruation
研究概览
简要总结
A study to explore whether rhythmical massage and heart rate variability biofeedback can help to reduce pain in women suffering from menstrual pain (dysmenorrhea).
详细描述
This is a three-arm randomized controlled trial to evaluate the efficacy of rhythmical massage and HRV biofeedback in women with primary dysmenorrhea compared to a control group. The main focus is on pain intensity during menstruation. Moreover, analgesics intake, SF-12 mental and physical scores and parameters of a 24h-HRV measurement are assessed before and after the three-month intervention.
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
- None
入排标准
- 年龄范围
- 16 Years 至 46 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least one year of primary dysmenorrhea (physician-confirmed).
- •Written informed consent (also from parents/legal guardians of underage girls).
- •Menarche at least one year ago.
排除标准
- •Secondary dysmenorrhea.
- •Participation in another study.
- •Mental retardation.
- •Addiction.
研究组 & 干预措施
Rhythmical massage
Participants who receive rhythmical massage for three months.
干预措施: Rhythmical massage (Other)
HRV biofeedback
Participants who perform HRV biofeedback for three months.
干预措施: HRV biofeedback (Behavioral)
Control group
Participants who do not receive an intervention during the three-month intervention period but are advised to stay with their usual care during menstrual pain. For ethical and compliance reasons, these participants receive a series of rhythmical massage treatments after the initial three-month intervention/control period.
结局指标
主要结局
Mean pain intensity during menstruation
时间窗: Baseline (pre intervention) and after three months (post intervention).
Mean pain intensity on the three days of maximal menstrual discomfort, as indicated by the participants on a numeric rating scale in a pain diary.
次要结局
- SF-12 sum-score(Baseline (pre intervention) and after three months (post intervention).)
- RMSSD(Baseline (pre intervention) and after three months (post intervention).)
- Analgesics intake during menstruation(Baseline (pre intervention) and after three months (post intervention).)
- Maximum pain intensity during menstruation(Baseline (pre intervention) and after three months (post intervention).)
- SF-12 mental(Baseline (pre intervention) and after three months (post intervention).)
- SF-12 physical(Baseline (pre intervention) and after three months (post intervention).)
- LF/HF-Ratio(Baseline (pre intervention) and after three months (post intervention).)
- SDNN(Baseline (pre intervention) and after three months (post intervention).)