| CTRI Number |
CTRI/2024/05/067943 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of virtual reality during various procedures like venipuncture in children with hematological malignancies |
|
Scientific Title of Study
|
Effect of Virtual Reality on procedural pain and anxiety among Pediatric Hematology Oncology patients during venipuncture |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alka Yadav |
| Designation |
Professor, Pediatrics department |
| Affiliation |
Pt.B.D.Sharma Post Graduate Institute of Medical Sciences |
| Address |
Ward 14
Pediatrics department
Pt.B.D.Sharma Post Graduate Institue of Medical Sciences, Rohtak
124001
Haryana
India
Rohtak
HARYANA
124001
India |
| Phone |
8607407313 |
| Fax |
|
| Email |
alkadv9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alka Yadav |
| Designation |
Professor, Pediatrics department |
| Affiliation |
Pt.B.D.Sharma Post Graduate Institute of Medical Sciences |
| Address |
Ward 14
Pediatrics department
Pt.B.D.Sharma Post Graduate Institue of Medical Sciences, Rohtak
124001
Haryana
India
Rohtak
HARYANA
124001
India |
| Phone |
8607407313 |
| Fax |
|
| Email |
alkadv9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riya |
| Designation |
Junior Resident |
| Affiliation |
Pt.B.D.Sharma Post Graduate Institute of Medical Sciences |
| Address |
Ward 14 Department Pediatrics
Pt.B.D.Sharma Post Graduate Institute of Medical Sciences
Pin-124001
Haryana
India
Rohtak
HARYANA
124001
India |
| Phone |
7015571071 |
| Fax |
|
| Email |
riyasaini1608@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.B.D.Sharma Post Graduate Institute of Medical Sciences, Rohtak ,Haryana ,124001 |
|
|
Primary Sponsor
|
| Name |
Dr Alka Yadav |
| Address |
Professor Pediatrics ward 14 Pt.BDSharma Post Graduate Institute of Medical Sciences 124001
Rohtak
Haryana
India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrRiya |
Pt.B.D.Sharma Post Graduate Institute of Medical Sciences Rohtak |
Pediatrics Department
First dovision
Room 5
Rohtak haryana
Rohtak Haryana
Rohtak
HARYANA |
7015571071
riyasaini1608@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee,Pt.B.D.Sharma PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C96Z||Other specified malignant neoplasms of lymphoid, hematopoietic and related tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No use of Virtual Realty environment in rest 50 patients |
No use of virtual reality environment in 50 patients
Direct veni puncture will be done without any virtual reality environment with routine standard of care |
| Intervention |
Use of Virtual reality devise JioDive360VR Headset |
Virtual Reality environment will be given in 50 subjects after randomisation from total 100 subjects and in rest 50 no Virtual reality environment will be given |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Oncology patients admitted in pediatric ward for diagnostic or therapeutic indications
Patient whose parents are able to speak and understand Hindi or English |
|
| ExclusionCriteria |
| Details |
Parents who denied consent
Patients /parents with active neurological or psychological problem
Patients with any hearing or vision problem
Patients with any hemodynamic instability |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Use of Virtual Reality helps in reducing pain and anxiety during repeated venipuncture in hematology oncology patients |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of parental anxiety and stress in the patients of hematology oncology children using ADSS scale |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/06/2024 |
| 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="1"
Months="0"
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
|
We will recruit 100 children from which after randomization 50 patients will be exposed to Virtual realty environment using JioDive 360VR while venipuncture and rest 50 will not be exposed to any Virtual Reality environment and the pain will be assessed using PedsQTLM3.0 Present functioning Visual Analogue Scale Parents of the exposed. Children will be given ADSS questionnaires to determine the level of anxiety and stress after their children has been diagnosed with haematological cancers . At the end of procedure study subjects will be re-evaluated for post procedural pain and anxiety . |