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CTRI Number  CTRI/2023/11/059561 [Registered on: 06/11/2023] Trial Registered Prospectively
Last Modified On: 05/11/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [video information intervention]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Can an educational video in which how anesthesia is done in children shown before surgery reduce anxiety in parents whose children are undergoing anaesthesia for elective surgeries  
Scientific Title of Study   EFFECT OF VIDEOTAPED INFORMATION ON ANXIETY OF PARENTS WHOSE CHILDREN ARE 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  DR AJAY ALEX JACOB 
Designation  Post graduate registrar 
Affiliation  CMC Vellore 
Address  Anaesthesia Office,7th floor ,Paul Brand Building,Christian Medical College,Ida Scudder road ,vellore,tamilnadu

Vellore
TAMIL NADU
632004
India 
Phone  8556948408  
Fax    
Email  ajayalexjacobcmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR SMITHA ELIZABETH GEORGE 
Designation  Associate Professor 
Affiliation  CMC Vellore 
Address  Department of Anaesthesia Christian Medical College vellore

Vellore
TAMIL NADU
632001
India 
Phone  9655820582  
Fax    
Email  smitha.lizgeorge@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR AJAY ALEX JACOB 
Designation  Post graduate registrar 
Affiliation  CMC Vellore 
Address  Anaesthesia Office,7th floor ,Paul Brand Building,Christian Medical College,Ida Scudder road

Vellore
TAMIL NADU
632001
India 
Phone  8556948408  
Fax    
Email  ajayalexjacobcmc@gmail.com  
 
Source of Monetary or Material Support  
FLUID RESEARCH GRANT FROM CHRISTIAN MEDICAL COLLEGE  
 
Primary Sponsor  
Name  CMC vellore 
Address  Christian Medical College, IDA Scudder Rd, Vellore, Tamil Nadu 632004 
Type of Sponsor  Private 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 
Ajay Alex Jacob  Christian Medical College Hospital  Department of Aneasthesia,Peadatric Anesthesia Block,ISSC building,CMC
Vellore
TAMIL NADU 
9567871795

ajayalexjacobcmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Review Board,Christian Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PERIOPERATIVE PARENTAL ANXIETY 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EDUCATIONAL VIDEOTAPED INFORMATION  In Interventional Group,the parents whose children is undergoing surgery is shown informative video regarding how aneasthesia is done in children and how they are taken care of inside theatre.their anxiety scoring is done pre and post intervention using STAI Questainnaire. DURATION-6 MONTHS 
Comparator Agent  ROUTINE VERBAL INFORMATION  Control Group will be given the routine pre anaesthesia information regarding how anaesthesia is given in children preoperatively in ward.anxiety scoring is done pre information and post information using STAI Questainnaire. DURATION-6 MONTHS 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  parents of children aged from 1 to 12 years 
 
ExclusionCriteria 
Details  Parents will be excluded if they were illiterate, had taken anxiolytic medications in the last 72hours, or have cognitive impairment, sensory impairment or severe mental illness,  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difference In Anxiety Of Parents who watched informative video and routine information using STAI Questainnaire  Baseline
5 months 
 
Secondary Outcome  
Outcome  TimePoints 
To access the other causes and factors affecting anxiety in parents of the children undergoing elective surgeries under anesthesia  6 MONTHS 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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   Phase 3 
Date of First Enrollment (India)   14/11/2023 
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="6"
Days="10" 
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  

The purpose of this study is to evaluate the effect of an educational video on the anxiety scores of parents whose children are scheduled for elective surgeries under anaesthesia, and compare it with anxiety scores of parents provided with verbal information as given routinely.

 We propose to conduct a non-randomized controlled trial where one group is shown  videotaped information and other group  routine  information is shared prior to  induction of anaesthesia.  Anxiety scores  of the parents in both groups prior to elective surgeries is assessed using STAI questionnaire and anxiety levels are compared.Each parent agreeing to be part of the study will be given a self administered anxiety scoring questionnaire in their own language based on the STAI to assess their baseline anxiety about their child’s upcoming procedure. The participants of the study will be divided into two groups depending on the week of the elective surgery.. All the eligible participants whose children are scheduled for elective surgery on one particular week will be allotted as group 1 where routine preoperative information about the elective surgery will be provided by the concerned anaesthesiologist.

The eligible participants who present on the next week(alternative weekly) ie  Group 2 will be given routine preoperative information as the other group, and then will additionally be provided with further detailed  videotaped information (see the appendix) on safety measures taken during anesthesia; how the anesthesia would be administered, the drugs used and their possible side effects; possible complication of anesthesia and  their interventions; and the post anesthesia period..There is no additional information which is going to be provided in videotaped information when compared to the routine information provided in PAC. .

On the dayprior to surgery, routine pre procedure information about the anaesthetic procedure for surgery will be provided to parents by the anaesthesiologists in the operating room as per routine practice.

 
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