Effectiveness of an Acupressure Band for Primary Dysmenorrhea in College Students: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change from Baseline in Average Menstrual Pain Intensity Measured by the Visual Analog Scale (VAS)
研究概览
简要总结
This study aims to investigate the effectiveness of an acupressure band in improving primary dysmenorrhea among college students. Primary dysmenorrhea is characterized by cramping lower abdominal pain during menstruation and is often accompanied by symptoms such as nausea, fatigue, and headache. It is also one of the leading causes of academic and work absenteeism among women of reproductive age. Previous studies have shown that acupressure applied to the Sanyinjiao (SP6) acupoint can alleviate menstrual pain. In addition, current clinical research has mainly focused on auricular acupressure using Vaccaria seeds, while relatively few studies have explored their application on body acupoints. Therefore, this study focuses on the application of Vaccaria seeds on the Sanyinjiao (SP6) acupoint to evaluate their effects on primary dysmenorrhea.
To provide continuous and stable acupoint stimulation, this study utilizes an intervention device combining Vaccaria seeds with a compression band, together with acupressure stimulation.
This study adopts a single-blind randomized controlled trial design. A total of 30 participants will be randomly assigned to either the experimental group or the control group (compression band only group). The study consists of four menstrual cycles, including one baseline menstrual cycle followed by three consecutive menstrual cycles of home-based intervention.
Outcome measures include the Visual Analog Scale (VAS) for pain intensity, the Menstrual Distress Questionnaire (MEDI-Q) for menstrual-related symptoms and distress, and heart rate variability (HRV), monitored using the ANS Watch as an indicator of autonomic nervous system activity. Statistical analyses will be conducted to compare differences between the experimental and control groups, as well as between pre- and post-intervention measurements, in order to evaluate the clinical potential of the acupressure band for primary dysmenorrhea management.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 24 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female university students aged 20 to 24 years.
- •Diagnosed with primary dysmenorrhea and having a Visual Analog Scale (VAS) pain score of 3 or higher.
- •Regular menstrual cycles ranging from 21 to 35 days.
- •Menstrual duration ranging from 4 to 10 days.
排除标准
- •Known history of secondary dysmenorrhea, including endometriosis or uterine fibroids.
- •Chronic medical disease or psychiatric disease.
- •Current smoking.
- •Pregnancy.
- •Long-term use of oral contraceptives or presence of an intrauterine device.
- •Significant lower-extremity pitting edema, abnormal lower-extremity circulation, marked swelling, skin damage, infection, sensory abnormalities, or other conditions considered unsuitable for wearing the acupressure band by the research staff.
研究组 & 干预措施
Compression Band Only
Participants will wear the compression band only, without Vaccaria seeds, and apply the band to the same location to serve as a control.
干预措施: Compression band only (Device)
Compression Band with Vaccaria Seeds
Participants will wear a compression band combined with vaccaria seeds applied to the Sanyinjiao (SP6) acupoint to receive continuous acupressure stimulation during menstruation.
干预措施: Compression band with vaccaria seeds (Device)
结局指标
主要结局
Change from Baseline in Average Menstrual Pain Intensity Measured by the Visual Analog Scale (VAS)
时间窗: From baseline (Cycle 1) through the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.
Menstrual pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). During each menstrual period, participants will record their average and maximum pain intensity each evening. The average menstrual pain intensity for each menstrual cycle will be calculated from the daily VAS records and used for the primary outcome analysis.
次要结局
- Change from Baseline in Menstrual Distress Questionnaire (MEDI-Q) Total Score(At baseline (Cycle 1) and at the end of the third intervention menstrual cycle (Cycle 4); menstrual cycle length is 21-35 days.)
研究者
Yu-Chen Lee
Director, Department of Acupuncture
China Medical University Hospital