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临床试验/CTRI/2024/04/066225
CTRI/2024/04/066225尚未招募1 期

Effect Of Virtual Reality Relaxation Environment On Heart Rate Variability And Blood Pressure In Hypertensive Individual Attending Tertiary Care Centre, Bhavnagar Compared To Healthy Volunteers

DR HINABEN DASHRATHBHAI CHAUHAN1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Pulse rate, Blood Pressure, Heart Rate Variability(HRV)

研究概览

简要总结

(1)Permission of ethics committee of GMC Bhavnagar will be taken.

(2)Participants as case group will be recruited those having hypertension with ongoing  treatment from medicine OPD at  Sir . T. Hospital, Bhavnagar

(3)Participants as control group will be recruited those age matched apparently healthy individual without any recent medical history.

(4)Participants will be recruited based on  the inclusion/exclusion criteria .

(5) Written informed consent of all the participants will be taken.

(6) Pulse rate, heart rate variability and blood pressure  measurements will be collected  before stimuli.

(7) Both groups will be given immersive virtual reality (relaxation) scene of forest for 10 minutes .

(8) Immersive Virtual reality(relaxation) scene of forest stimuli will be given for 10 minutes to both group of study as mentioned above

(9) Heart rate variability and blood pressure  measurements will be collected after immersive virtual reality(relaxation) stimuli.

(10) Data will be entered in excel file. Comparison of  heart rate variability and blood pressure measurements will be done between both study groups. Analysis will be done by using appropriate statistical software .

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 80.00 Year(s)(—)
性别
All

入选标准

  • For case group: Apparently Healthy individual of age 18 and above with hypertension ongoing treatment(on same medication last 15 days) and up to stage of JNC VII CRITERIA For control group: age matched apparently healthy individual without any recent medical history.

排除标准

  • For case: Patients with a history of nausea, vomiting or motion sickness and without any injury or illness.
  • For control :Participants with a history of nausea, vomiting or motion sickness and without any injury or illness.

结局指标

主要结局

Pulse rate, Blood Pressure, Heart Rate Variability(HRV)

时间窗: baseline and immediately after intervention

次要结局

未报告次要终点

研究者

发起方
DR HINABEN DASHRATHBHAI CHAUHAN
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR HINABEN DASHRATHBHAI CHAUHAN

Government medical college bhavnagar

研究点 (1)

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