Efficacy of Pranayama on depression, stress, anxiety and quality of life in females with diagnosed polycystic ovarian syndrome: A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1. Depression, Anxiety and Stress scale-21 items (DASS-21)
研究概览
简要总结
This study focuses on evaluating the effectiveness of pranayama compared to moderate intensity continuous training (MICT) in improving mental health, sleep quality, and quality of life in women with polycystic ovarian syndrome (PCOS). Women with PCOS often experience higher levels of stress, anxiety, and depression, which can negatively affect their quality of life. While MICT is known to reduce these symptoms, many women face barriers to regular physical activity. Pranayama, a simpler and more time-efficient practice, may offer similar benefits without the side effects of medications or the challenges of daily exercise, making it a promising alternative therapy.
62 participants will be included and everyone will be given a sequential number. Then the participants will be randomly divided into two groups by computer random generated number list.
Each group will have 31 participants each.
Group A will be the intervention group receiving a structured Pranayama protocol including 5 Pranayama and Shavasana
Group B will be a control group receiving MICT
The protocol will be of 30 minutes thrice a week for 6 weeks.
Depression, anxiety and stress scale-21 items (DASS-21), Health related quality of life questionnaire for women with PCOS (PCOSQOL) and Sleep quality scale(SQS) are the outcome measures which will be taken before and 6 weeks of intervention.
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females in the reproductive age group between 18-40 years who are pre diagnosed with PCOS and are fulfilling mild or moderate scoring criteria of minimum of one component in depression or stress or anxiety (DASS-21) questionnaire are included.
- •The cut off scores for mild depression is 10-20, for anxiety is 8-14 and for stress is 15-25.
排除标准
- •Pregnant women Females having any acute diseases or problems of heart or lung Undergoing active pharmacological treatment for stress, anxiety and depression.
结局指标
主要结局
1. Depression, Anxiety and Stress scale-21 items (DASS-21)
时间窗: Pre treatment assessment and after six weeks of intervention
2. Health related quality of life questionnaire for women with polycystic ovarian syndrome (PCOSQOL)
时间窗: Pre treatment assessment and after six weeks of intervention
次要结局
- Sleep Quality Scale(SQS)
研究者
Dr Umisha Madhur Rathi
K J Somaiya College of Physiotherapy