Combined Effect of Reflexology and General Stretching on Insomnia Vesomotor Symptoms and Quality of Life in Post-menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The purpose of this study is to assess how reflexology and general stretching affect postmenopausal women's quality of life, vasomotor symptoms, and insomnia. Hormonal changes in postmenopausal women frequently result in hot flashes, sleep difficulties, and a general reduction in quality of life. Although non-pharmacological treatments like stretching and reflexology have demonstrated promise in treating these symptoms on their own, little study has evaluated how well they work together.
详细描述
Purposive sampling was used to choose postmenopausal women between the ages of 45 and 60 for a randomized controlled experiment. Participants were divided into two groups at random: the group participating in the experiment received generalized stretching exercises and reflexology, whereas the control group only received stretching or routine care. Three sessions a week for six weeks was the duration of the intervention. Standardized instruments such as the Menopause Ratings Scale (MRS) for vasomotor complaints, the severity index for insomnia (ISI), and the menu menopausal particular aspects of life and post-intervention evaluations were used to measure outcomes. The effectiveness of the measures was then compared."
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women aged between 45 and 60 years
- •Women experiencing insomnia, vasomotor symptoms (e.g., hot flashes), and reduced quality of life
- •Women who are at least 12 months amenorrheic
- •Willing to participate and provide informed consent
- •Physically able to perform stretching exercises
排除标准
- •Women on hormone replacement therapy or other medications affecting sleep or menopause symptoms
- •History of recent surgery or musculoskeletal injuries preventing physical activity
- •Diagnosed psychiatric or neurological disorders
- •Severe systemic illnesses (e.g., uncontrolled diabetes, cardiovascular diseases)
- •Participation in another clinical trial or intervention in the last 3 months
研究组 & 干预措施
Reflexology + Generalized Stretching
干预措施: Reflexology + Generalized Stretching (Combination Product)
Stretching Only
干预措施: Stretching Only (Combination Product)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: 6 Month
insomnia. Each item is rated from 0 (no problem) to 4 (very severe problem). Total Score Range: 0-28 0-7: No clinically significant insomnia 8-14: Subthreshold insomnia 15-21: Moderate insomnia 22-28: Severe insomnia
Menopause Rating Scale (MRS)
时间窗: 6 Months
Assesses 11 common menopausal symptoms divided into three subscales: somatic, psychological, and urogenital. Each symptom is rated from 0 (none) to 4 (very severe). Total Score Range: 0-44 Higher scores indicate more severe symptoms
Menopause-Specific Quality of Life Questionnaire (MENQOL)
时间窗: 6 months
A 29-item self-report scale that measures the impact of menopause on quality of life in four domains: Vasomotor (3 items) Psychosocial (7 items) Physical (16 items) Sexual (3 items) Each item is scored from 0 (not at all bothered) to 6 (extremely bothered). Higher scores indicate greater symptom burden and lower quality of life.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University