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CTRI Number  CTRI/2025/05/087838 [Registered on: 28/05/2025] Trial Registered Prospectively
Last Modified On: 24/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To assess the role of Virtual Reality as an adjunct to systemic analgesia during rehabilitation in patients undergoing Total Knee Replacement 
Scientific Title of Study   To assess the role of Virtual Reality as an adjunct to systemic analgesia during rehabilitation in patients undergoing Total Knee Replacement- a prospective randomized controlled study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajiv Dhunna 
Designation  director and head anesthesiology 
Affiliation  IVY HEALTH AND LIFE SCIENCES 
Address  Departent of anaesthesiology, first floor, IVY hospital and health and life sciences, mohali, sector 71, 160059

Chandigarh
CHANDIGARH
160059
India 
Phone  9815224447  
Fax    
Email  drrajivmd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rajiv Dhunna 
Designation  director and head anesthesiology 
Affiliation  IVY HEALTH AND LIFE SCIENCES 
Address  Department of anaesthesiology,first floor IVY hospital and health and life sciences, mohali, sector 71, 160059

Chandigarh
CHANDIGARH
160059
India 
Phone  9815224447  
Fax    
Email  drrajivmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajiv Dhunna 
Designation  director and head anesthesiology 
Affiliation  IVY HEALTH AND LIFE SCIENCES 
Address  Department of anaesthesiology, First floor IVY hospital and health and life sciences, mohali, sector 71, 160059

Chandigarh
CHANDIGARH
160059
India 
Phone  9815224447  
Fax    
Email  drrajivmd@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Ivy Health and Life Sciences 
Address  IVY HEALTH AND LIFE SCIENCES, SECTOR-71, MOHALI, Punjab, 160059 
Type of Sponsor  Research institution and hospital 
 
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 Rajat Singla  IVY health and life sciences  Department of anaesthesiology first floor, Ivy health and Life sciences,sector 71, Mohali, Punjab, 160059
Rupnagar
PUNJAB 
09992211881

singla.rajat90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee Ivy Hospital Mohali  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patient planned to undergo B/L TKR for degenerative OA.
Age above 18 years
Both male and female
Orientation, comprehension, communication of certain level based on a certain screening questionnaire. 
 
ExclusionCriteria 
Details  H/O Vision problem (Hypermetropia)
H/O Hearing problem (SNHL)
H/O Recurrent headache
Refusal (Non consenting).
H/O Migraine that precipitated with glaring lights.
•Complaining of headache, dizziness on a 15 min trial of VR.
•Patient who have been given PNB and epidural analgesia (central nerve block) for post operative analgesia. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Comparison of pain scores during a 30-minute physiotherapy session conducted at two time points: Day 0 (4 hours post-operative) and Day 1 (24 hours post-operative).
2.Difference in range of motion at joint on Day 0, Day 1.  
At Day2 
 
Secondary Outcome  
Outcome  TimePoints 
1.Maximum range achieved at discharge or Day 2 (if discharged late).
2.Requirement of systemic analgesics during the duration of rehabilitation.
3.Side effects in terms of Headache, dizziness, nausea & vomiting. 
At Day 2 
 
Target Sample Size   Total Sample Size="212"
Sample Size from India="212" 
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   N/A 
Date of First Enrollment (India)   10/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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-identification.

  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 - Anyone

  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 (Others) -  Link will be provided post publication

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Beginning 3 months and ending 5 years following article publication.

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

All patients will be admitted either on the day prior to surgery or on the day of surgery. Each patient will undergo a standard pre-anesthetic check-up, which includes clinical examination, laboratory investigations, radiological assessments, and other necessary evaluations. Eligible patients will be counseled regarding participation in the study and provided with detailed information about all modalities of postoperative analgesia, including the use and content streaming capabilities of virtual reality hardware. The counseling session will also include identification of the patient’s area of interest in relation to the content to be streamed through virtual reality during the postoperative period. Patients will be invited to select content of their preference from a predefined menu of available options. Patients will be divided into two groups i.e. study group (group S) and control group (group C) with each n = 106. After obtaining written informed consent from patients, Patients will be taken up to the operation theater after reviewing attached PAC, monitors were attached, venous access secured. Surgery (B/L TKR) will be performed under SAB. Both the groups will receive same drug dose and concentration i.e.  Bupivacaine heavy 0.5% 16mg with Fentanyl 25mcg with 26G Quincke needle either at L4-L5 or L3-L4 lumber intervertebral space. All surgeries were performed by same orthopaedic team. After the insertion of the joint prosthesis, peri-articular infiltration of a cocktail of drugs- morphine 10mg, ketorolac 35mg, ropivacaine 0.2% 100ml, and adrenaline 200mcg—was given, divided equally in both knees before closure of the capsule. After the completion of surgery patient will be shifted to orthopaedic ICU for post operative recovery.  Rehabilitation exercises will be initiated at modified bromage scale of zero confirming that the motor blockade has weaned off [Table No:-1]. The control group received intravenous injections of paracetamol 1gm, every 6th hourly, diclofenac 75mg 12th hourly, and tramadol 100mg 8th hourly. The study group will receive same analgesics, but as per need after application of VR.

 
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