| CTRI Number |
CTRI/2025/07/091715 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of digital imitation on Pain Fear and Anxiety among paediatric patients undergoing cancer injections into the spine |
|
Scientific Title of Study
|
Effect of virtual reality headset device on pain, fear and anxiety in Paediatric Cancer Patients during Lumbar Punctures (LP) at a Tertiary Care Centre in Mumbai. Open label RCT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Pawar |
| Designation |
professor cum vice principal |
| Affiliation |
Tata Memorial hospital Mumbai |
| Address |
13th floor Homi Bhabha Block nursing education department room no 1311 Dr E Borges Marg Parel Mumbai
Mumbai Maharashtra 400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738059723 |
| Fax |
|
| Email |
manisha.19pawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manisha Pawar |
| Designation |
professor cum vice principal |
| Affiliation |
Tata Memorial hospital Mumbai |
| Address |
13th floor Homi Bhabha Block nursing education department room no 1311 Dr E Borges Marg Parel Mumbai
Mumbai Maharashtra 400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
7738059723 |
| Fax |
|
| Email |
manisha.19pawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
miss Vaishali Raut |
| Designation |
PG student |
| Affiliation |
Tata memorial hospital Mumbai |
| Address |
nursing education department room no 1311 Dr E Borges Marg Parel Mumbai
Mumbai Maharashtra 400012
India
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8862063920 |
| Fax |
|
| Email |
vaishus9893@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Parel, Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Dr E Borges Road, Parel Mumbai 400012 |
| 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 Manisha Pawar |
Tata Memorial Hospital |
Golden jubilee Building 3rd floor minor OT Department of Nursing Education Dr E Borges Marg Parel Mumbai
Mumbai
MAHARASHTRA |
7738059723
manisha.19pawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee 1 3rd floor main building tata memorial hospital Parel Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C910||Acute lymphoblastic leukemia [ALL], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard care |
Participants will be randomly assigned to two groups using a computer generated sequence, Sequence 1 and sequence 2,
sequence 1 Receives the VR intervention during the first LP and standard care during the second LP.
sequence2 Undergoes standard care during the first LP and receives the VR intervention during the second LP. |
| Intervention |
virtual reality headset device
|
The investigator will tell and discuss about the purpose of VR glasses and what they are hearing and seeing through the goggles. like Swimming with marine animals Riding roller coaster Exploring the forest through the eye of the woodland species. the pre assessment for pain fear and anxiety will be performed by the investigator by using Wong backer pain scale, CAMS and CFS, before the procedure. Children will be place in the standard side lying position for their LP with the virtual reality headset device ,The VR goggles will remain throughout the procedure. Post procedure VR headset device will be removed and the response will be recorded by the investigator the investigator collect data after 5 minutes after LP T2 for pain fear and anxiety with the help of standardized tool WBS CSF and CAMS Investigator collect data for pain after 15 minutes T3 of procedure with the help of WBS Investigator collect data for pain after 30 minutes T4 of procedure with the help of WBS Recorded data will be shared with the statistician for data analysis. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with Leukemia in the age group of 7-15 years undergoing L.P. for
chemotherapy.
2. Who is cognitively appropriate when assessed by a pediatrician and psychologist as
appropriate to use VR, with consent from parents or guardians.
3. Caregivers and children who can understand English/Hindi/Marathi. |
|
| ExclusionCriteria |
| Details |
1. Active nausea or vomiting
2. Developmental delay: Children who cannot verbalize.
3. Children who cannot tolerate applying a VR headset device during the procedure.
4. History of seizures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of VR as a distraction technique in reducing
pain during paediatric lumbar punctures.by using Wong baker pain scale |
pain is assessed consistently across all participants. Pain levels will be
measured at four time points using the Wong-Baker FACES WBS Pain Rating Scale in both the VR intervention group and the standard care group. The assessment time points are as
follows T1 at 5 minutes before the procedure
T2at Immediately 5 minutes post lumbar puncture LP
T3 at 15 minutes after the LP
T4 at 30 minutes after the LP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the pain, fear and anxiety levels experienced during LP of
pediatric patients receiving VR intervention versus those receiving standard care.by using the
Children Fear Scale and Children Anxiety Meter-Scale in children from the age group of 7to15
years with leukaemia undergoing LP. |
to compare the effect of fear and Anxiety levels of children at the baseline before and 10 minutes after lumbar puncture for intrathecal chemotherapy using the children fear scale and children anxiety meter scale |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
07/08/2025 |
| 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="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
|
The study will be initiated after ethical approval from IEC at TMH .children for intrathecal injection during LP will be allowed to participate in the study subject to written informed consent of parents and assent of child . Eligible participant according to inclusion criteria will take into participation . The investigator will tell and discuss about the purpose of VR glasses and what they are hearing and seeing through the goggles. like swimming with marine animals, Riding roller coaster Exploring the forest through the eye of the woodland species . The pre assessment for pain fear and anxiety will be performed by the investigator by using Wong backer pain scale, CAM-S and CFS before the procedure. The VR goggles will remain throughout the procedure. Post procedure VR headset device will be removed and the response will be recorded by the investigator .The investigator collect data after 5 minutes after LP T2 for pain, fear and anxiety with the help of standardized tool WBS CSF and CAMS Investigator collect data for pain after 15 minutes T3 of procedure with the help of WBS . Investigator collect data for pain after 30 minutesT4 of procedure with the help of WBS . Recorded data will be shared with the statistician for data analysis. |