Efficacy of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- To assess the effectiveness of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women.
研究概览
简要总结
The study will be started after obtaining ethical clearance from Institutional Ethics Committee. Informed & written consent will be taken prior the recruitment. All study participants in the study will undergo detailed history (present, past, gynaecological, medical, and family history) followed by general physical examination. The participants will be selected on the basis of inclusion criteria and will be randomly assigned to the yoga or control groups in a 1:1 ratio; the randomization will be done by using a computer program. 4 scales will be used for assessment & follow up i.e. Pittsburgh Sleep Quality Index (PSQI) (19), The Menopause-specific Quality of Life (MENQOL) (20), Menopause rating scale (MRS) (21) and Insomnia Severity Index (ISI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Perimenopausal women between ages 40 to 55years with recent onset of sleep disturbances.
- •Having sleep disturbances 3 nights/wk at least for 3 months(12) Women not having any psychiatric illness Accessibility to smartphone Willing to participate Practising sleep hygiene.
排除标准
- •Having psychiatric disorders,anxiety or heart disease.
- •Co-existing Orthopaedic problems and chronic illnesses.
- •Current participation in structured exercise or yoga programs Undergoing hormone replacement therapy H/O cancer Premature ovarian failure.
结局指标
主要结局
To assess the effectiveness of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women.
时间窗: TFrom Baseline to end of intervention at week 4 week 8 week 12.
次要结局
- 1. To assess the effect of Yoga on other somatic symptoms among Perimenopausal Women(2. To assess the effect of yoga on overall QOL among Perimenopausal Women.)
研究者
Dr Neel Kamal
Government Institute of Medical Sciences(GIMS)