FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Status 
Not Applicable 
 
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.
 
Close