Effects of Chamomile With L-theanine Beverage Among Young Women Experiencing Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Sleep quality
研究概览
简要总结
This study aims to evaluate the effects of a beverage containing chamomile and L-theanine on menstrual symptoms, pain intensity, mood, and sleep quality among young adult females with primary dysmenorrhea.
详细描述
This study aims to evaluate the effects of a beverage containing chamomile and L-theanine on menstrual symptoms, pain intensity, mood, and sleep quality among young adult females with primary dysmenorrhea.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A VAS score of ≥4 cm for the past three consecutive menstrual cycles
- •Regular monthly menstruation
- •No history of allergies or psychological/gynecological illnesses
- •Absence of secondary dysmenorrhea
- •No current use of any medications
- •No ongoing non-pharmacological management for dysmenorrhea.
排除标准
- •Breastfeeding
结局指标
主要结局
Sleep quality
时间窗: 2 months
The Pittsburgh Sleep Quality Index (PSQI) is used to assess the sleep quality of participants during the past week. The total PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Mood
时间窗: 2 months
The Profile of Mood States (POMS) is used to assess six mood subscales (vigor, tension, depression, anger, fatigue, and confusion) of participants during the past week. Each item is rated on a 5-point Likert scale, ranging from 0 (not at all), 1 (a little), 2 (moderately), 3 (quite a lot), and 4 (extremely).
Pain intensity
时间窗: 2 months
The pain intensity is assessed using the Visual Analogue Scale (VAS) and the Numeric Rating Scale (NRS). Participants mark the point on the scale (0 to 10) that best represents the average intensity of their menstrual pain. A higher score on the VAS and NRS indicates greater pain intensity.
Menstrual symptoms
时间窗: 2 months
The Cox Menstrual Symptom Scale (CMSS) is used to assess the severity of menstrual-related symptoms experienced by participants during their most recent menstrual cycle. Each item in the CMSS is rated on a scale from 0 (not noticeable), 1 (slightly bothersome), 2 (moderately bothersome), 3 (severely bothersome), to 4 (very severely bothersome).
次要结局
- Hemoglobin(2 months)
研究者
Tan Chin Xuan
Assistant Professor
Universiti Tunku Abdul Rahman