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
|
|
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
|
|
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. |