| CTRI Number |
CTRI/2024/05/067987 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study using augmented reality to decrease anxiety in children before anesthesia. |
|
Scientific Title of Study
|
A randomised controlled study evaluating augmented reality for alleviation of preoperative anxiety in paediatric patients undergoing surgery under general anaesthesia |
| 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 Nisha |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad medical College |
| Address |
Department of Anaesthesiology Maulana Azad medical College and Lok nayak hospital, bahadur Shah zafar marg Central delhi, 110002
Central
DELHI
110002
India |
| Phone |
8700385701 |
| Fax |
|
| Email |
nishakulhari1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kapil Chaudhary |
| Designation |
Professor |
| Affiliation |
Maulana Azad medical College |
| Address |
Department of Anesthesiology, Maulana Azad Medical College and Lok Nayak hospital Central delhi
Central
DELHI
110002
India |
| Phone |
9871262699 |
| Fax |
|
| Email |
Kapsdr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad medical College |
| Address |
Department of Anaesthesiology Maulana Azad Medical College and Lok Nayak hospital, bahadur Shah zafar marg Central Delhi
Central
DELHI
110002
India |
| Phone |
8700385701 |
| Fax |
|
| Email |
nishakulhari1111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Maulana Azad Medical College and Lok Nayak hospital bahadur Shah zafar marg New Delhi, 110002 India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical College |
| Address |
Department of Anesthesiology and Intensive care, Maulana Azad medical College 110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Nisha |
Lok nayak hospital and Guru Nanak Eye centre |
OT-2 and OT-3 Lok nayak hospital and Main OT Guru Nanak Eye centre, Maulana Azad medical College 2 Bahadur Shah zafar marg,new delhi 110002
Central
DELHI |
8700385701
nishakulhari1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Augmented reality technique |
Patients will be exposed to augmented reality techniques
in preoperative room and this will be continued till induction of anaesthesia to check anxiety scores at baseline, during shifting to operation room and before induction |
| Comparator Agent |
Control group |
Patients in this group will receive standard care and not exposed to augmented reality techniques.Assessment of anxiety using anxiety scores will be done at baseline ( preoperative room), before shifting to operation room and before induction |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
-ASA physical status 1-3
-Paediatric patients of age 2 years till 7 years |
|
| ExclusionCriteria |
| Details |
-Patients with impaired vision or hearing or language barrier
-Patients with developmental delay
-Patients on preoperative sedative drugs
-Patients asleep during preoperative monitoring period
-Patients with history of previous anaesthesia exposure, chronic disease or growth retardation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients having mYPAS-SF score more than 30 in augmented reality and control group before induction |
Before induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Paediatric induction compliance |
During induction |
| Time to induction of Anaesthesia |
During induction |
| Parental anxiety |
1. Baseline
2. After induction |
| Parental satisfaction |
Post operative |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
10/06/2024 |
| 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 Applicable |
| 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
|
Preoperative paediatric anxiety is common and can have negative psychological impact on children undergoing anaesthesia and surgery. Various audiovisual distraction techniques like virtual reality have proven to be effective in lowering anxiety as assessed by modified Yale Preoperative anxiety scale(mYPAS). Augmented Reality is a newer, interact technology that allows users to simultaneously view the real world environment with digital image overlay. The aim of our study is to evaluate efficacy of Augmented Reality technology in alleviating preoperative anxiety in paediatric patients of age group 2-7 years.
|