| 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
|
|
|
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
|
|
|
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) |