| CTRI Number |
CTRI/2024/09/073253 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of immersive virtual reality in decreasing the analgesic requirement during dressing change in children with burn injuries. |
|
Scientific Title of Study
|
Effect of immersive virtual reality in decreasing the analgesic requirement during dressing change in children with burn injuries: A prospective, cross-over, 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 |
Abirami S |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care,
All India Institute of Medical Sciences, New Delhi.
Junior Resident (January 2024),
Department of Anesthesiology, Pain Medicine and Critical Care,
All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
9444536726 |
| Fax |
|
| Email |
sabiramisboa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abirami S |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care,
All India Institute of Medical Sciences, New Delhi.
Junior Resident (January 2024),
Department of Anesthesiology, Pain Medicine and Critical Care,
All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
9444536726 |
| Fax |
|
| Email |
sabiramisboa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darlong V |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Anesthesiology, Pain Medicine and Critical Care
AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
9821607809 |
| Fax |
|
| Email |
darlongv@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, India 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029 |
| 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 Darlong V |
All India Institute of Medical Sciences, New Delhi |
Burns and Plastic Surgery Intensive Care Unit and Burns Ward
AIIMS Burns and Plastic Surgery Department
Ansari Nagar West
New Delhi 110029
South
DELHI |
9821607809
darlongv@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T311||Burns involving 10-19% of body surface, (2) ICD-10 Condition: T312||Burns involving 20-29% of body surface, (3) ICD-10 Condition: T313||Burns involving 30-39% of body surface, (4) ICD-10 Condition: T314||Burns involving 40-49% of body surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Immersive Virtual Reality in addition to routine standard of care of burns dressing |
Smart phone mountable Immersive Virtual Reality Headset is used to distract the child in addition to routine standard of care during burns dressing |
| Comparator Agent |
routine standard of care of burns dressing |
routine standard of care which includes the administration of intravenous Fentanyl 1 mcg per kilogram before the beginning of bandage removal and 0.5mcg per kilogram of intravenous fentanyl whenever the child expresses signs of distress due to pain during the dressing change |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
5 years to 15 year old children with less than 50% total body surface area of burn injury that occurred within the past 5 days and need intravenous analgesia for pain management during dressing change |
|
| ExclusionCriteria |
| Details |
Patient is excluded if they have facial burns or if their visual acuity or development is low enough to hamper seeing and understanding the video played or if there is profound hearing loss or in case of parent or child refusal or if the fitting of headset is highly uncomfortable for the patient or if the patient has history of motion sickness or has undergone surgery for the burn injury since admission |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the total incremental dose of Intravenous Fentanyl consumed during dressing change |
at the end of the dressing change |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wong Baker FACES Pain Scale |
Before, immediately after and 15 mins after completion of dressing |
| time to first incremental analgesic bolus requirement and number of boluses given |
recorded every time a bolus dose of intravenous fentanyl is given |
| hemodynamic parameters like heart rate and oxygen saturation |
from fifteen minutes before to fifteen minutes after the dressing at every five minute interval |
| Patient and Parental Satisfaction on Likert Scale |
after completion of dressing |
| dresser satisfaction on the Likert Scale |
after completion of the dressing |
| any adverse effect due to virtual reality distraction therapy |
throughout the dressing |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
11/09/2024 |
| 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="2"
Months="0"
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 - NO
|
|
Brief Summary
|
This study is a cross over, randomized, controlled to study the effect of immersive virtual reality in decreasing the analgesic requirement during dressing change in children with burn injuries .The primary outcome measure will be the total incremental dose of Intravenous Fentanyl consumed during dressing change in children who receive Immersive virtual reality distraction therapy in addition to routine standard of care versus those who don’t. The secondary outcome measures include Wong Baker FACES Pain Scale, hemodynamic parameters, patient, patient and dresser satisfaction on Likert Scale. |