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CTRI Number  CTRI/2023/09/058054 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 26/09/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the use of methods other than medicine to improve anxiety level in children who will undergo surgery. 
Scientific Title of Study   "Impact of audiovisual and non- pharmacological interventions to alleviate preoperative anxiety in children : A randomized clinical trial " 
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. Bibha Kumari 
Designation  Associate Professor  
Affiliation  Indira Gandhi Institute of Medical Sciences  
Address  Department of Anesthesiology and CCM, 1st floor IGIMS Ward Block

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swati Singh  
Designation  Assistant professor  
Affiliation  Indira Gandhi institute of medical sciences  
Address  Department of Anesthesiology and CCM, 1st floor IGIMS ward block

Patna
BIHAR
800014
India 
Phone  9878309230  
Fax    
Email  drswatisingh21@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sarthak Misra 
Designation  MD trainee  
Affiliation  Indira Gandhi institute of medical sciences  
Address  Department of Anesthesiology and CCM, 1st floor IGIMS ward block

Patna
BIHAR
800014
India 
Phone  8210641979  
Fax    
Email  drsarthakmisra2021@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi institute of medical sciences  
 
Primary Sponsor  
Name  Dr Bibha Kumari  
Address  Department of anesthesiology and CCM first floor ward block Igims Patna  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Sarthak Misra   Indira Gandhi institute of medical sciences   Neuro ot complex first floor ward block
Patna
BIHAR 		 8210641979

drsarthakmisra2021@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, IGIMS  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 
Intervention  Audio-visual and non pharmacological methods   comics, toys, cartoon, animation videos about surgery  
Comparator Agent  Routine pre op evaluation and counseling.  The comparing group will get the normal routine pre operative examinations. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details 

Patients parents willing to participate.
Patients 4-11 years of age.
Patients with no developmental delay.
ASA grade 1-2 patients.
Operative procedure requiring General Anaesthesia.

 
 
ExclusionCriteria 
Details  Patients with hearing impairments, verbal communication problems. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the impact of use of interactive multimedia, other methods to relieve preoperative anxiety in pediatric patients.  1.Day before the surgery.
2.Preoperative waiting area.
3.At the time of separation from parents and moving to operation theatre.
4.At the time of induction.
5.After 6 hours of surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
Asses the postoperative need of analgesic & postoperative anxiety.

 		 1.Day before the surgery.
2.Preoperative waiting area.
3.At the time of separation from parents & moving to operation theatre.
4.At the time of induction.
5.After 6 hours of surgery.
 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/10/2023 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsarthakmisra2021@gmail.com].

  6. For how long will this data be available start date provided 31-08-2024 and end date provided 31-08-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Given the large number of surgeries performed in children, it is imperative to optimize the surgical outcome by reducing the perioperative anxiety in both children and their parents. The methods should be employed according to the age and developmental stage of child. In this study we will use comic books, videos, toys for preoperative education to reduce anxiety in young pediatric patients. 
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