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CTRI Number  CTRI/2026/02/104278 [Registered on: 19/02/2026] Trial Registered Prospectively
Last Modified On: 29/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study comparing different techniques of reducing surgery related anxiety among children  
Scientific Title of Study   A randomized controlled trial on non-pharmacological techniques of reducing anxiety among children undergoing elective surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sreyashi Naskar 
Designation  Fellow, Paediatric Anaesthesia 
Affiliation  Indira Gandhi Institute of Child Health, Bangalore 
Address  Department of Anaesthesiology Indira Gandhi Institute of Child Health Bangalore Karnataka 560029

Bangalore
KARNATAKA
560029
India 
Phone  6290153836  
Fax    
Email  sreyashi.n@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sreyashi Naskar 
Designation  Fellow, Paediatric Anaesthesia 
Affiliation  Indira Gandhi Institute of Child Health, Bangalore 
Address  Department of Anaesthesiology Indira Gandhi Institute of Child Health Bangalore Karnataka 560029

Bangalore
KARNATAKA
560029
India 
Phone  6290153836  
Fax    
Email  sreyashi.n@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sreyashi Naskar 
Designation  Fellow, Paediatric Anaesthesia 
Affiliation  Indira Gandhi Institute of Child Health, Bangalore 
Address  Department of Anaesthesiology Indira Gandhi Institute of Child Health Bangalore Karnataka 560029

Bangalore
KARNATAKA
560029
India 
Phone  6290153836  
Fax    
Email  sreyashi.n@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Child Health Bangalore Karnataka 560029 
 
Primary Sponsor  
Name  Department of Anaesthesiology 
Address  Indira Gandhi Institute of Child Health Bangalore Karnataka 560029 
Type of Sponsor  Government medical college 
 
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 Sreyashi Naskar  Department of Anaesthesiology, Indira Gandhi Institute of Child Health  South Hospital Complex, Dharmaram College Post Bangalore- 560029 Karnataka 560029
Bangalore
KARNATAKA 
6290153836

sreyashi.n@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, Indira Gandhi Institute of Child Health, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Cartoon video group  To choose and view one from 5 different popular, age and language appropriate cartoon videos, which the patient likes most or is familiar with; each having 3-5 minutes duration  
Intervention  Control group  The anaesthetist verbally informs and consoles the patient, inside the OR before surgery- according to his/ her own discretion 
Comparator Agent  Virtual Reality tour of Operation theatre- group  Smartphone compatible virtual reality headset (VR Box™) (40 mm lens in 3D box with head-straps) used to view a 3D virtual audio-visual tour of the operation theatre, of approximately 1 minute duration  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. ASA grade: I, II
2. Patients who are scheduled for any elective diagnostic or therapeutic surgical procedure
3. Patients whose parent/ LAR are willing to give written consent
 
 
ExclusionCriteria 
Details  1.Patient refusal at any stage, even after parent/LAR have given consent
2. ASA grade III/ IV/V
3. Patients who are expected to be sedated/ mechanically ventilated or shifted to ICU after surgery
4. Patients who have undergone surgery/or anaesthesia in the past
5. Any psychological/ behavioral disorder, those on psychoactive medications, those with history of epilepsy or seizure
6. Blind, deaf and mute patients
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
modified Yale Preoperative Anxiety score reduction from baseline, to post intervention  Baseline- in the preanaesthesia room, Post intervention- immediately after shifting inside OR before induction of anaesthesia; and third reading- immediately after recovery in the recovery room 
 
Secondary Outcome  
Outcome  TimePoints 
Studying the acceptance rate of the different anxiolysis techniques among the study participants  Baseline- only once while introducing the intervention first time, to each patient 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/03/2026 
Date of Study Completion (India) 29/05/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 29/05/2026 
Estimated Duration of Trial   Years="0"
Months="3"
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  

Perioperative anxiety in children undergoing surgeries, is found to be associated with multiple clinical and behavioral adverse outcomes- increased analgesic requirements, emergence delirium(ED), sleep disturbances, enuresis. The use of sedative premedication, however should not be considered as the first and only method to allay their anxiety, as none of the pharmacological agents used for this purpose is found to be ideal or free from adverse effects. Moreover, administering such drugs mandates availability of monitoring and resuscitative equipments, as well as adequate fasting periods. In the light of the wide range of non-pharmacological methods available to reduce anxiety in children, it is imperative that paediatric anaesthesiologists utilize these techniques wherever possible and make the entire experience of undergoing anaesthesia and surgery more comfortable and physiological for them.

However, due to the already established efficacy of the pharmacological premedications, there exists some hesitation with the use of non-pharmacological interventions, and the efficacy of these techniques are only recently being studied. To the best of our knowledge, there is scarcity of literature comparing multiple such techniques, and hence, comparing their efficacy may give us direction and more clarity on their future use and implementation on regular basis.

We compare the efficacy of two non- pharmacological anxiolysis techniques to allay anxiety among (5-14) year old children undergoing elective surgeries with respect to a control group, where verbal preparation was used by the anaesthetists at their own discretion. The groups compared were:

1. Individual cartoon video (Test- group V)

2. Guided tour of operation theatre using VR headset(Test- group VR)

3. Verbal preparation at the discretion of the anaesthetist during PAE and in OT (Control- group C)

 
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