| CTRI Number |
CTRI/2025/05/086955 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Virtual Reality device for displaying virtual reality images/videos as a modality for decreasing pain perception in paediatric patients after the surgery. |
|
Scientific Title of Study
|
Virtual Reality as an analgesic modality for postoperative pain in paediatric patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pulla Rao Yesupongu |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9515086474 |
| Fax |
|
| Email |
drypraombbs93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nazia Tauheed |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7895330665 |
| Fax |
|
| Email |
naziatauheed15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazia Tauheed |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7895330665 |
| Fax |
|
| Email |
naziatauheed15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
PIN code-202002. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical Care Jawaharlal Nehru Medical College AMU |
| Address |
Department of Anesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
PIN code-202002. |
| Type of Sponsor |
Government medical college |
|
|
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 Pulla Rao Yesupongu |
Jawaharlal Nehru Medical College and Hospital |
Post-Anaesthesia Care Unit
Department of Anaesthesiology and Critical Care, Aligarh, Uttar Pradesh
Aligarh
UTTAR PRADESH |
9515086474
drypraombbs93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(Regd) Jawaharlal Nehru Medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
The standard care(SC) group will be given only the standard postoperative analgesic protocol i.e intravenous(IV) paracetmol 15mg/kg every 6 hours.
The following
parameters would be recorded at different time intervals - immediately after
surgery, 2hrs, during the use of VR and 6 hours after surgery.
- FLACC score
- Heart rate and MAP
- Perfusion index (average of 3 values 30 seconds apart)
- Need for rescue analgesia would be noted in terms of time of
administration and number of doses given in 1 st 24hrs postoperatively.
Rescue analgesia would be given when the FLACC score is more than or equal
to 4 with a 20% increase in pulse rate and MAP from the baseline. It would be
injection ketorolac 0.5 mg/kg with a maximum of 3 doses in the first 24 hours
after surgery. |
| Intervention |
Use of Virtual Reality Head Mounted Device for postoperative analgesia |
36 patients will be included as cases[Group Virtual Reality(VR)] and 36 patients will be used as
controls [Group Standard Care(SC)]. Group VR patients would be given instructions regarding
the virtual reality device in a language that patient will understand. They will be
asked to wear HMD and watch a 3D motion visual in VR for 10 - 30 minutes in
the preoperative period for familiarisation.
Preoperative and intraoperative medications would be as per the standard
institutional protocol for general anaesthesia. Once the patient is sdhifted to the
postanaesthesia care unit, standard monitoring would continue. Both the groups
will be given the standard postoperative analgesic protocol, i.e. intravenous
(IV) paracetamol 15mg/kg every 6hrs.
The VR group patients would be given the HMD device at 5hrs after surgery
which they would be allowed to use up to a maximum of 30min. The following
parameters would be recorded at different time intervals - immediately after
surgery, 2hours after surgery, during the use of VR and 6 hours after surgery.
- FLACC score
- Heart rate and MAP
- Perfusion index (average of 3 values 30 seconds apart)
- Need for rescue analgesia would be noted in terms of time of
administration and number of doses given in 1 st 24hrs postoperatively.
Rescue analgesia would be given when the FLACC score is more than or equal
to 4 with a 20% increase in pulse rate and MAP from the baseline. It would be
injection ketorolac 0.5 mg/kg with a maximum of 3 doses in the first 24 hours
after surgery.
Patients in the group VR requiring rescue analgesia before the use of VRT
would be excluded from the study. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 6-10 years.
Body weight of 8-40kg.
ASA grade I, II, III patients.
No history of neurological/ cognitive, visual or auditory dysfunction.
No delayed mile stones/ congenital anomalies.
Patients undergoing abdominal and urological procedures. |
|
| ExclusionCriteria |
| Details |
No parental consent
Patients requiring post operative ICU care/ventilatory support.
Patients with congenital anomalies and delayed mile stones
Children who are suffering from any syndromes
History of claustrophobia
History of susceptibility to motion sickness.
Lack of cooperation during familiarization - anxiety or discomfort while
viewing 3D environment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the effect of VR on postoperative pain in paediatric patients in terms
of need for rescue analgesic(time & number of doses in first 24 hours) |
Immediately after
surgery, 2hrs after surgery, during the use of VR and 6 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the effect of VR on postoperative pain in paediatric patients in terms
of
- FLACC score
- changes in hemodynamic parameters (pulse rate, mean arterial pressure)
- changes in perfusion index |
Immediately after
surgery, 2hrs after surgery, during the use of VR and 6 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 4 |
|
Date of First Enrollment (India)
|
27/05/2025 |
| 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 - NO
|
|
Brief Summary
|
This thesis explores the use of Virtual Reality (VR) as an analgesic modality for managing postoperative pain in pediatric patients. Given the limitations and side effects of opioid and non-opioid medications, VR offers a promising non-invasive alternative by distracting patients and reducing their perception of pain. The study will be a prospective, randomized trial involving 72 children undergoing abdominal and urological surgeries. It aims to compare VR intervention with standard postoperative pain management, measuring outcomes such as the need for rescue analgesia, FLACC pain scores, and physiological parameters. If successful, VR could become an effective adjunct for pediatric pain relief. |