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临床试验/CTRI/2024/06/069206
CTRI/2024/06/069206尚未招募不适用

A Randomised Controlled Trial on the Autonomic and Cardiovascular Effects of Indian Classical Music on Young Healthy Individuals

Sreelakshmi K1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
116
试验地点
1
主要终点
Systolic Blood Pressure

研究概览

简要总结

This is a randomised, double- blinded, parallel group, single centre study to know the effect of Indian classical music ( Raga Puriya) on cardiac autonomic functioning of healthy human volunteers.The parameters studied are Systolic Blood Pressure, Diastolic Blood Pressure, Pulse Pressure , Mean Arterial Blood Pressure, Heart Rate and Heart Rate Variability.After the baseline assessment, each participant will be randomized either into the experimental group or the control group using block randomization technique. A Ten-minute, pre-recorded instrumental rendition of raga Puriya will be played via headphones connected to a laptop, at a uniform volume (50%)  to the experimental group.In the control group ,natural sounds (birds chirping and flowing river) will be played for 10 seconds duration once every 2 min. The Systolic Blood Pressure, Diastolic Blood Pressure, Pulse Pressure , Mean Arterial Blood Pressure, Heart Rate and Heart Rate Variability will be recorded during and post music interventions and compared between two groups using T test and ANOVA.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
20.00 Year(s) 至 30.00 Year(s)(—)
性别
All

入选标准

  • Individuals of age 20-30 years of either gender medically and surgically healthy give consent to participate in the study.

排除标准

  • Smokers Alcoholics.
  • Hypertensives Participants on any medication known to affect the BP or autonomic status of the individual.
  • Pregnancy Body mass index (BMI) more than 30 kg/m2.

结局指标

主要结局

Systolic Blood Pressure

时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline

Diastolic Blood Pressure

时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline

Pulse Pressure

时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline

Mean Arterial Blood Pressure

时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline

Heart Rate

时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline

Heart Rate Variability

时间窗: During music exposure-baseline | Post music exposure-10 minutes after baseline

次要结局

未报告次要终点

研究者

发起方
Sreelakshmi K
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sreelakshmi K

Department of Physiology, Pushpagiri Institute of Medical Sciences and Research Centre

研究点 (1)

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