| CTRI Number |
CTRI/2024/07/070395 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of digital imitation on Pain Fear and Anxiety among pediatric patients undergoing cancer injections into the spine |
|
Scientific Title of Study
|
Effect of virtual reality headset device on pain fear and anxiety in Pediatric Cancer Patients during Lumbar Punctures LP at a Tertiary Care Centre in Mumbai Open label RCT |
| 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 Manisha Pawar |
| Designation |
Professor cum Vice Princilpal |
| Affiliation |
Tata Memorial Hospital |
| Address |
13th floor Homi Bhabha block nursing education department Room No 1311 Dr E Borges Marg Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
7738059723 |
| Fax |
|
| Email |
manisha.19pawar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sonal Ashish Panchal |
| Designation |
MSc Nursing Student |
| Affiliation |
Tata Memorial Hospital |
| Address |
13th floor Homi Bhabha Block Nursing Education Department Room No 1311 Dr E Borges Marg Parel Mumbai India
Mumbai MAHARASHTRA 400012 India |
| Phone |
9892177850 |
| Fax |
|
| Email |
sonalkedar2689@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sonal Ashish Panchal |
| Designation |
Co investigator |
| Affiliation |
Tata Memorial Hospital |
| Address |
13th floor Homi Bhabha block nursing education department Room No 1311 Dr E Borges Marg Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
9892177850 |
| Fax |
|
| Email |
sonalkedar2689@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Association of Supportive Care in Cancer MASCC @ Apple Suites
16 Industrial Parkway South Unit 412 Aurora ON L4G 0R1 Canada |
|
|
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
|
| Name |
Address |
| Not Any |
Not Any |
|
|
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 |
| Institutional Ethics Committee:1 3rd floor Main Building Tata Memorial Hospital Dr E Borges Marg Parel Mumbai 400012 India |
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 |
| Intervention |
Effect of virtual reality headset device on pain fear and anxiety in Pediatric Cancer Patients during Lumbar Punctures |
Counselling regarding virtual reality will be done before intervention.
The investigator will discuss a standardized script that will be used to explain the purpose of VR glasses to participants and the need to focus their attention on what they are hearing and seeing instead of the procedure.
Participants in the group will be provided with virtual reality glasses to wear after Intrathecal Chemotherapy.
Children will be placed in the standard side lying position for their LP with a Virtual Reality Headset Device.
VR headset device will have a three-dimensional system viewing and listening to music in stereo sound.
The VR video is around 32 minutes long and was recorded in succession to provide a total of 64 minutes of footage.
The video was titled "Escape" and was distributed by VIRTUAL I-O Portland OR Atkins 1996.
Post procedure VR headset device will be removed and the response will be recorded by the investigator.
Response will be recorded with the use of data collection tools Wong-Baker Pain Scale and Children Anxiety Meter Scale and Child Fear Scale.
Children Fear Scale and Children Anxiety Meter Scale developed by McMurtry et al. 2011.
Recorded data will be shared with a statistician for data analysis. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Leukemia in the age group of 7 to 15 years undergoing LP for chemotherapy
Cognitively appropriate participants will be included after assessment by the
Paediatrician and Clinical Psychologist as appropriate to use VR with consent from caregivers
Patients who provide assent
Caregivers and children who can understand English or Hindi or Marathi. |
|
| ExclusionCriteria |
| Details |
Active nausea or vomiting
Developmental delay
Children who are unable to verbalize
Children who are not able to tolerate the application of a VR headset device during the procedure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary purpose of this study is to determine the feasibility of implementing VR by using the Wong-Baker pain scale in children from the age group of 7 to15 years with leukaemia undergoing LP for Intrathecal chemotherapy |
The primary purpose of this study is to determine the feasibility of implementing VR by using the Wong-Baker pain scale in children from the age group of 7 to15 years with leukaemia undergoing LP for Intrathecal chemotherapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the feasibility of Virtual Reality on fear & anxiety by using the Children Fear Scale & Children Anxiety Meter Scale in children from the age group of 7 to 15 years with leukaemia undergoing Lumbar Puncture |
To compare the effect of Fear & Anxiety levels of children at the baseline before & 10 minutes after Lumbar Puncture for intrathecal chemotherapy using the Children Fear Scale & Children Anxiety Meter Scale |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/07/2024 |
| Date of Study Completion (India) |
03/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Phase I The feasibility 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 the child The exclusion criteria will be strictly applied to finalize the subject A coded subject ID will be assigned to the children Demographic and outcome data will be obtained from the medical records of the child. The screening proforma will be completed for children with case record forms before intervention A general physical examination will be done for all children by the paediatrician and clinical psychologist. The diagnosis will be noted as well as recorded The Pain and Fear and Anxiety Score outcomes of all eligible participants will be monitored All data about VR feasibility will be recorded from the case file to the data collection instrument in English The data will be regularly transmitted to the computer in the MS Excel database and stored electronically. All source documents and reports will be stored in the file cabinet. The paediatrician and psychologist will be made aware of the intervention. Recording of Pain and Fear and Anxiety will be carried out by the investigator before taking the child to OT with the help of the Wong Baker Pain Scale and Children Fear Scale and Children Anxiety Meter Scale Data Collection Tools The child will be taken in the OT a left lateral position will be given and a VR headset device will be placed on the child until the completion of intrathecal chemotherapy. The investigator will record the Pain score at 5 and 15 and 30 minutes of the procedure Fear and Anxiety with the help of data collection tools. Data will be collected recorded and sent to a statistician for further analysis and interpretation. |