Evaluation of a Smartphone Application for Self Care for Women With Menstrual Pain (Primary Dysmenorrhea): a Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 594
- 试验地点
- 1
- 主要终点
- Mean pain intensity on the days with pain
研究概览
简要总结
With a randomized, pragmatic study the effectiveness of a smartphone app for menstrual pain in 18-34-year-old women with primary dysmenorrhea will be investigated.
详细描述
Smartphone apps may be useful to guide and support individuals in self-management strategies. Primary dysmenorrhea is a very common problem for women. With a randomized, pragmatic study the investigators aim to evaluate whether a smartphone app for women with menstrual pain is effective in reducing menstrual pain in 18-34-year-old women with primary dysmenorrhea. For this the investigators compare the complete smartphone app with two control versions of this app. The complete app provides evidence-based self-care information and instructions for self-acupressure in menstrual pain, the control intervention I includes self-care information, but no instructions for self-acupressure, and control intervention II includes instructions for self-acupressure, but no self-care information. The investigators aim to observe 594 women with primary dysmenorrhea over 12 menstruation cycles. The primary outcome is the mean pain intensity on the days with pain during the 6th menstruation after randomization using a numerical rating scale (NRS; 0=no pain; 10=strongest pain imaginable). Women are eligible when they suffer from primary dysmenorrhea, are between 18 and 34 years old, not pregnant and do not plan to be pregnant within the next 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 18-34 years
- •Dysmenorrhea, defined as self-reported menstrual cramps or pain during every menstrual cycle which started during the teenage years
- •No prior history of a gynecological disease that is known to be a reason for the dysmenorrhea
- •Not more than 5 days with menstrual pain outside the menstrual period itself
- •Menstruation within the last six weeks and a cycle length of 3 to 6 weeks
- •Moderate or severe pain, defined as a score equal to or higher than 6 on a numeric rating scale (NRS, 0 to 10) for the worst pain intensity during the last menstruation
- •Informed consent
- •Possession of an iPhone
- •Willingness and ability to input and share anonymous data through the study app
- •The willingness to see a doctor when 1) pain is getting worse than usual, 2) pain medication is not helping, and 3) when the pain is still present well before or well after the period.
排除标准
- •Known pregnancy
- •Pregnancy already planned for the forthcoming 12 months
研究组 & 干预措施
Complete app
198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature.
干预措施: Self-care information feature (Other)
Complete app
198 women with primary dysmenorrhea who receive an app which includes a self-care information feature and a self-acupressure feature.
干预措施: Self-acupressure feature (Other)
Control intervention I
198 women with primary dysmenorrhea who receive an app for menstrual pain which includes the self-care information feature, but not the self-acupressure feature.
干预措施: Self-care information feature (Other)
Control intervention II
198 women with primary dysmenorrhea who receive an app for menstrual pain which includes the self-acupressure feature, but not the self-care information feature.
干预措施: Self-acupressure feature (Other)
结局指标
主要结局
Mean pain intensity on the days with pain
时间窗: Daily during the 6th menstruation after randomization
The mean pain intensity on the days with pain during the 6th menstruation after randomization using a numerical rating scale (NRS; 0=no pain; 10=strongest pain imaginable).
次要结局
- Adverse reaction(End of menstruation (1st to 12th menstrual cycles))
- User satisfaction(End of menstruation (1st to 12th menstrual cycles))
- Days with pain medication(Daily during menstruation (1st to 12th menstrual cycles))
- Responder(Daily during menstruation (1st to 12th menstrual cycles))
- Days with absence from work, training, or studies(Baseline, end of menstruation (1st to 12th menstrual cycles))
- Number of days with pain (duration of pain)(Daily during menstruation (1st to 12th menstrual cycles))
- Severe adverse events(End of menstruation (3rd, 6th, 9th, and 12th menstrual cycles))
- Frequency of acupressure application(5 days before menstruation and during menstruation (1st to 12th menstrual cycles))
- Mean pain intensity on the days with pain(Baseline; daily during menstruation (1st to 5th and 7th to 12th menstrual cycles))
研究者
Claudia M. Witt
Prof. Dr. med.
Charite University, Berlin, Germany