Immediate effect of neutral circular jet on autonomic variables among hypertensive patients: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Primary Outcome: HRV (Heart Rate Variability)
研究概览
简要总结
A study of a neutral circular jet given with a temperature of 92–95 degrees Fahrenheit for 15 minutes to find its effect upon the autonomic variables of patients with primary (essential) hypertension
20% completed
100% completed
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female Age range of 30–60 years Primary hypertension On regular medication Willing to participate in the study.
排除标准
- •Participants with a history of secondary hypertension Hypertensive complications Coronary heart disease Stroke Mental illness Female having menstruation Pregnancy Pyrexia Not willing to participate.
结局指标
主要结局
Primary Outcome: HRV (Heart Rate Variability)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
a) Frequency domain (LF, HF, LH/HF)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
I. The low-frequency band (LF)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
II. High Frequency (HF) band
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
III. The LF/HF ratio will be calculated
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
b) Time domain (R-R interval, RMSSD, NN50, pNN50)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
时间窗: Primary Outcome: HRV (Heart Rate Variability) | a) Frequency domain (LF, HF, LH/HF) | I. The low-frequency band (LF) | II. High Frequency (HF) band | III. The LF/HF ratio will be calculated | b) Time domain (R-R interval, RMSSD, NN50, pNN50) | I. The mean R-R interval (the mean of the intervals between adjacent QRS (complexes or the instantaneous heart rate) | II. RMSSD (the square root of the mean of the sum of the squares of differences between adjacent NN intervals) | III. NN50 (the number of interval differences of successive normal to normal intervals greater than 50ms) | IV. pNN50 (the proportion derived by dividing NN50 by the total number of NN intervals)
次要结局
- Blood pressure (SBP and DBP) Pulse rate Respiratory rate Spo2(The evaluations will be taken five minutes before the intervention, followed by a post-assessment five minutes later and the data will be assessed)
研究者
Dr Vipin Pant
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences