Impact of cold douche to abdomen on gastric myoelectrical activity and autonomic variables in healthy young adults
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gatric motility and Heart rate Variablity
研究概览
简要总结
Douche is a hydrotherapeutic modality which uses water application with pressure to desired body parts using a single or multiple columns of water. In the therapeutic employment of the douche, active three factors are: temperature, pressure and duration . Anecdotal studies show that cold abdominal douche can be helpful in managing the altered gastric motility. It is essential to understand the underlying mechanisms before applying them as a theraputic agents. So the present study was designed to assess the influence of cold douche to abdomen on gastric myoelectrical activity.
Grouping
30 healthy subjects will be assessed at 2 times with a wash out period of 2 days by dividing into 2 groups with equal number
2 Groups
Group 1 (n=15)
Group 2 (n=15)
The institutional ethical clearance will be obtained prior to the conduct of the study. An informed consent will be obtained from the individuals by explaining the study objectives, methods, intervention after an appraisal about the study protocol. All the rights of the individual pertaining to the study will be explained to the individual in their convenient language.
after selecting the elegible subjects. Allotment will be done by using a computer generated random number
Day 1: Subject 1- Cold douche to abdomen(5min)
Subject 2- neutral douche to abdomen
Day 4: Subject 1- neutral douche to abdomen(5min)
Subject 2- Cold douche to abdomen(5min)
Assessments will be done before and after intervention at time intervals at T= 0,1,2,3
T= 0(baseline)
T= 1(immediately after the intervention)
T= 2(30minutes after intervention)
T= 3(1hr after intervention)
th
t
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 30.00 Year(s)(—)
- 性别
- All
入选标准
- •subjects who are willing to participate in the study after signing the informed consent form.
排除标准
- •1 Weak and debilitating individuals 2 Any medical illness/ taking medications 3 Recent surgeries 4 Smokers and alcoholics 5 Caffeine intake before 24 hours.
结局指标
主要结局
Gatric motility and Heart rate Variablity
时间窗: baseline, immediately after intervention, 30min after intervention and 1hr after intervention
次要结局
- •To quantify the change in dominant power and dominant frequency of gastric motility induced by cold douche to abdomen.(•To assess the percentage of change in normogastric, bradygastric and tachygastric waves.)
研究者
Dr Mithun A C
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire
