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CTRI Number  CTRI/2024/08/071984 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Effect of virtual goggles to decrease anxiety and improve success of CT scan in children 
Scientific Title of Study   Effect of immersive virtual reality in reducing anxiety and improving success during paediatric computed tomography imaging – An observational 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  Shreya Shah 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 6, 4th floor, Porta cabin, Ward block, Emergency building, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  09892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shreya Shah 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 6, 4th floor, Porta cabin, Ward block, Emergency building, AIIMS, New Delhi


DELHI
110029
India 
Phone  09892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Shreya Shah 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Room no 6, 4th floor, Porta cabin, Ward block, Emergency building, AIIMS, New Delhi


DELHI
110029
India 
Phone  09892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  Department of Anaesthesiology Pain Medicine and Critical Care AIIMS New Delhi 
Address  Department of Anaesthesiology, 5th floor, Academic block, AIIMS, New Delhi -110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreya Shah  All India Institute of Medical Sciences  Department of Anaesthesiology, 5th floor, Academic block, AIIMS, New Delhi
New Delhi
DELHI 
9892652781

shreyabs@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C649||Malignant neoplasm of unspecifiedkidney, except renal pelvis, (2) ICD-10 Condition: C399||Malignant neoplasm of lower respiratory tract, part unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Preschool and school aged children between 3 to 8 years
2. Children scheduled for CT imaging under sedation
3. ASA physical status I/II/III
 
 
ExclusionCriteria 
Details  1. CT scan of the head, paranasal sinuses, orbit
2. Children with mental, auditory, or visual impairment
3. Anticipated difficult airway
4. Unstable patient or urgent procedure
5. Allergy to EMLA cream or any of the intravenous sedatives used
6. Parent/guardian refusal
7. Child refusal
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the percentage of pre-school and school aged children (3 to 8 years) who successfully complete CT imaging under virtual reality without supplementary intravenous sedation  30 minutes before CT scan and during the procedure of CT scan till its completion 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the affect and cooperation of children during CT scan under virtual reality
2. To determine the mean dose of intravenous sedatives required for successful completion of CT imaging
3. To determine the number of interruptions during the scanning procedure
4. To determine the satisfaction scores by the attending radiologist

 
30 minutes before CT scan and during the procedure of CT scan till its completion 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   15/08/2024 
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 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   Diagnostic tests often provoke fear and anxiety in pediatric patients, leading to the need for sedation or general anaesthesia (GA). Virtual reality has been used as a distraction tool in children during various minor procedures, circumventing the need for sedation. However, its use as an alternative to pharmacological anxiolysis during CT scan has never been explored. This single arm feasibility study aims to assess the feasibility of VR in decreasing anxiety among the pediatric patients undergoing CT scans. The primary objective is to determine the percentage of pre-school and school-aged children (3 to 8 years) who complete CT imaging under virtual reality without supplementary intravenous sedation. The secondary objectives are 1. To evaluate the affect and cooperation of children during CT scan under virtual reality 2. To determine the mean dose of intravenous sedatives required to successfully complete CT imaging  3. To determine the number of interruptions during the scanning procedure 4. To determine the satisfaction scores by the attending radiologist.
The Inclusion criteria are:1. Preschool and school aged children between 3 to 8 years 2. Children scheduled for CT imaging under sedation 3. ASA physical status I/II/IIIThe Exclusion criteria are: 1. CT scan of head, paranasal sinuses, orbit 2. Children with mental, auditory or visual impairment 3. Anticipated difficult airway 4. Unstable patient or urgent procedure 5. Allergy to EMLA cream or any of the intravenous sedatives used 6. Parent/guardian refusal 7. Child refusal. Parents will be explained in their language that their child will be participating in a study and written consent/assent will be obtained. Consecutive eligible patients over the duration of 1 year will be recruited.

Only uncooperative patients scheduled for the scan under sedation will be enrolled for the study. For the eligible patients, a modified Yale preoperative anxiety scale will be used to assess baseline anxiety in the holding area. In the preprocedural room EMLA cream will be applied. The patients will then be made to wear the VR headset while on the trolley. After 45 minutes, the site of EMLA application will be uncovered and intravenous cannulation will be attempted in the presence of the parents. The response to IV catheter placement will be graded using the Groningen Distress Rating Scale (GDRS). The number of attempts to successful cannula placement will be recorded. The parent’s satisfaction will be recorded.

After cannulation, children will be wheeled to the CT scanner for imaging. Pre-procedure anxiety score will again be noted and the procedure will be commenced. Patients will continue to watch the video before and until completion of the scanning. Patient cooperation will be assessed using a 5-point scale: 1 = cooperative; 2 = verbal resistance; 3 =some movement, intermittent restraint required; 4 = thrashing movements, continuous restraint required; and 5 =unable to complete procedure without intravenous medication. In cases where there is difficulty in completing the procedure because of the child’s anxiety or inability to remain still,  ketamine 0.5 mg/kg IV will be given as an initial dose, followed by subsequent doses of 0.5 mg/kg propofol IV if required. Oxygen supplementation via nasal prongs @2ltr/min will be provided and standard ASA monitoring will be employed. The total dose of intravenous agents required will be noted. Any movement, motion artifact or repeat scans reported by radiologist will be recorded. Any complications like desaturation, airway obstruction, vomiting or excessive salivation will also be noted.

Post procedure, the investigator will grade the affect of children as happy, relaxed, anxious or distressed, and their cooperativity using the HRAD+ scale. The radiographer/radiologist satisfaction with the procedure will be measured using a 5-point Likert scale, ranging from 1 ‘very dissatisfied’ to 5 ‘very satisfied. VR feasibility and technical issues will be recorded throughout the study period.

 Recovery time defined as the time from the end of sedation (if required) to physiologic recovery state allowing safe discharge from the CT suite. The patients will be shifted to the recovery area and observed for an hour after the scan. The children will be discharged when their vital signs are stable and consciousness has returned to an age-appropriate baseline. 


 
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