Effect of Pranayama on Physiological, Biochemical and Psychological Stress-Anxiety Response Patterns in Whole Blood Donors at Risk of Vasovagal Reaction at a Tertiary Care Centre: An Experimental Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 424
- 试验地点
- 1
- 主要终点
- To compare the changes in blood pressure, heart rate variability, galvanic stimulation response, anxiety status, and serum cortisol levels in whole blood donors at risk of vasovagal reaction after giving a session of 10 minutes of pranayama with the control group.
研究概览
简要总结
Blood donors visiting the blood centre of the Department of Transfusion Medicine to donate blood will be enrolled in this study using the inclusion criteria of the study. The pre-donation psychological stress-anxiety will be evaluated by questionnaire. The physiological stress anxiety will be evaluated by AD ( Analog and Digital ) instruments along with LabChart software and a sample will be taken for measuring cortisol level to evaluate biochemical parameter in study group with intervention given and also in control group that is whole blood donors not given any intervention.After this, these donors will be allocated in either study group or control group in a continuous sampling. In the study group, intervention in the form of Pranayama will be given for 10 minutes while in the control group, the donors will be rested for 10 minutes only. After 10 minutes, donors of both the groups will undergo blood donation. The physiological parameter will also be evaluated during blood donation. Twenty minutes after the blood donation, the same psychological, physiological and biochemical parameters will be evaluated from the donors of both the groups. The donors of both groups will also be observed for vasovagal reaction if any.The observer (Nursing staff and the doctor present in the blood donation room will be blinded. The intervention will be given in pre-donation room by the investigator
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1- Donors meeting the criteria of blood donation laid down by the Government of India Under the Drug and Cosmetic Rules 1945 (Amendment 2020) and Blood donors at risk vasovagal reaction.
- •Donors with prior history of Vasovagal reaction b.
- •Donors having overt apprehension or anxiety c.
- •Family donors whose first-degree relative is admitted in the hospital d.
- •First time donors e.
- •Female donors f.
- •Donors who slept in the hospital the previous night g.
- •Young donors (Age group 18-25 years) 2- Donors willing to be part of the study.
排除标准
- •Donors not willing to be part of the study.
结局指标
主要结局
To compare the changes in blood pressure, heart rate variability, galvanic stimulation response, anxiety status, and serum cortisol levels in whole blood donors at risk of vasovagal reaction after giving a session of 10 minutes of pranayama with the control group.
时间窗: 1. At baseline | 2. After Blood donation
次要结局
- To identify various risk factors for the vasovagal reaction in the donor population.(Post Donation)
研究者
Umesh Kumar Singh
AIIMS, Rishikesh