| 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
|
|
|
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
|
|
|
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
|
|
|
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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