| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Link will be provided post publication
- 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.
- 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. |