The Effect of Hydrogen-rich Water Consumption on Premenstrual Symptoms and Quality of Life in Students With Premenstrual Syndrome: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in premenstrual symptoms assessed by The Premenstrual Syndrome Scale
研究概览
简要总结
The aim of this study is to determine the effect of hydrogenated water on premenstrual symptoms and quality of life in students with premenstrual syndrome.
Research Hypotheses H1 1 Hydrogenated water consumption reduces premenstrual symptoms in students with premenstrual syndrome.
H1 2 Hydrogenated water consumption increases the quality of life in students with premenstrual syndrome.
The research will consist of intervention and control groups. Individuals consuming hydrogen-rich water will be included in the intervention group, whereas individuals consuming normal water will be in the control group. The block randomization method will be used to randomly assign participants who meet the research criteria to the groups. Participants will be provided with hydrogenated water for three cycles.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The length of the menstrual cycle is within normal limits (21-35),
- •Getting a score of 132 or more from the Premenstrual Syndrome Scale,
- •Not receiving medical treatment for PMS,
- •Not having any psychiatric diagnosis.
排除标准
- •• Irregular menstruation in the last three cycles
- •Having received a psychiatric diagnosis,
- •Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
- •Using contraceptive medication.
- •Individuals' refusal to participate in the study,
- •Participants' non-compliance with the research plan,
- •Participants start receiving PMS treatment during the study period.
结局指标
主要结局
Change in premenstrual symptoms assessed by The Premenstrual Syndrome Scale
时间窗: immediately before the intervention, immediately after the intervention, and 1 month after the intervention
The Premenstrual Syndrome Scale (PMSS) consists of 44 questions. The PMSS is Likert type and its items are scored between 1 and 5 points. Lowest points of 44 and highest points of 220 can be obtained on the PMSS. The scale has a total of 9 subscales: depressive feeling, anxiety, fatigue, irritability, depressive thoughts, pain, changes in appetite, changes in sleeping habits and swelling. A higher score on the scale indicates that the severity of premenstrual syndrome is high.
Change in quality of life assessed by World Health Organization Quality of Life
时间窗: immediately before the intervention, immediately after the intervention, and 1 month after the intervention
The brief version of the World Health Organization Quality of Life (WHOQOL-BREF) is a sound, cross-culturally valid assessment of health-related quality of life in adults populations. Its assessment shows good to excellent internal consistency, test-retest reliability, discriminant validity, content validity, and construct validity in the healthy population and in different patient groups. Each question is scored from 1 to 5, with scores ranging from 0-100. A higher score means better quality of life.
次要结局
未报告次要终点
研究者
Menekşe Nazlı AKER
Assist. Prof.
Ankara University