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CTRI Number  CTRI/2024/04/066225 [Registered on: 24/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Virtual Reality Relaxation Environment ]  
Study Design  Other 
Public Title of Study   Impact of Virtual Reality Relaxation Environment on Heart Rate Variability and Blood Pressure in Hypertensive Patients at a Tertiary Care Center in Bhavnagar Compared to Healthy Volunteers  
Scientific Title of Study   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  
Trial Acronym  VRHTN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR HINABEN DASHRATHBHAI CHAUHAN 
Designation  Resident at Physiology GMC Bhavnagar 
Affiliation  Government medical college bhavnagar 
Address  Resident room physiology department, Government medical college jail road,behind bus stand Bhavnagar
nil
Bhavnagar
GUJARAT
364001
India 
Phone  7984884932  
Fax    
Email  hinachauhan5678@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chinmay J Shah  
Designation  Professor and Head of Physiology GMC Bhavnagar 
Affiliation  Government medical college Bhavnagar 
Address  HOD office room no 1 physiology department Government medical college jail road ,behind bus stand Bhavnagar
nil
Bhavnagar
GUJARAT
364001
India 
Phone  9328938008  
Fax    
Email  chinmayffri@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR HINABEN DASHRATHBHAI CHAUHAN 
Designation  Resident at Physiology GMC Bhavnagar 
Affiliation  Government medical college Bhavnagar 
Address  Resident room physiology department, Government medical college jail road,behind bus stand Bhavnagar
nil
Bhavnagar
GUJARAT
364001
India 
Phone  7984884932  
Fax    
Email  hinachauhan5678@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR HINABEN DASHRATHBHAI CHAUHAN 
Address  Resident room,physiology department Government medical college jail road behind bus stand Bhavnagar  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR HINABEN DASHRATHBHAI CHAUHAN  Government Medical College Bhavnagar  Resident room Physiology Department Bhavnagar Bhavnagar
Bhavnagar
GUJARAT 		 7984884932

hinachauhan5678@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICSCOMMITEEGOVERNMENTMEDICALCOLLEGEBHAVNAGAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individual with complete physical ,mental and social well being  
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NO INTERVENTION  NIL 
Intervention  Virtual Reality Relaxation Environment   Only One time Virtual Reality Relaxation Environment WILL BE GIVEN FOR 10 MINS  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pulse rate, Blood Pressure, Heart Rate Variability(HRV)  baseline and immediately after intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hinachauhan5678@gmail.com].

  6. For how long will this data be available start date provided 01-05-2024 and end date provided 01-08-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

(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 .

 

 

 
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