| CTRI Number |
CTRI/2020/02/023114 [Registered on: 04/02/2020] Trial Registered Prospectively |
| Last Modified On: |
03/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Acceptance of Anaesthesia mask in children |
|
Scientific Title of Study
|
Comparison of Anaesthesia mask acceptance scores in children exposed to and not exposed to anaesthesia mask pre operatively during inhalational induction of anaesthesia- a prospective randomised trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samuel David Chandran |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Anaesthesia
Christian Medical College and Hospital
Ida Scudder Road
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9789497797 |
| Fax |
|
| Email |
samchandran19889@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Aparna Williams |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Anaesthesia
Christian Medical College and Hospital
Ida Scudder Road
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
8098899339 |
| Fax |
|
| Email |
williamsaparna@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Samuel David Chandran |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College and Hospital |
| Address |
Department of Anaesthesia
Christian Medical College and Hospital
Ida Scudder Road
Vellore
TAMIL NADU 632004 India |
| Phone |
9789497797 |
| Fax |
|
| Email |
samchandran19889@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College and Hospital
Ida scudder Road
Vellore 632004
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
Institutional Review board Fluid grant |
| Address |
Institutional Review Board
Christian Medical College
Vellore - 632002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Samuel David Chandran |
Christian Medical College and Hospital |
Paediatric surgeries in CB theater complex
Mother and child building Vellore TAMIL NADU |
9789497797
samchandran19889@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Christian Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, (2) ICD-10 Condition: L949||Localized connective tissue disorder, unspecified, (3) ICD-10 Condition: N29||Other disorders of kidney and ureter in diseases classified elsewhere, (4) ICD-10 Condition: M798||Other specified soft tissue disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Anaesthesia mask |
Anaesthesia mask will given to the child to play with on the previous night of surgery |
| Comparator Agent |
Nil |
The child will not be given an anaesthesia mask. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children belonging to ASA physical status
1, 2, 3 posted for elective surgical procedure. |
|
| ExclusionCriteria |
| Details |
Children with intravenous cannula in situ, history of seizures, developmental delay, ASA physical status 4 and 5 and emergency procedures. |
|
|
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 |
| Ease of Anaesthesia mask acceptance as indicated by the anaesthesia mask acceptance score |
during gas induction of anaesthesia in the induction room. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pre operative and pre induction anxiety levels in children using Yale paediatric anxiety scale |
At the holding bay and during gas induction of anaesthesia in the induction room. |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2020 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Undergoing surgery is a stressful period for any child. Children undergoing surgery are bound to be anxious due to unfamiliarity of the surroundings. One method to reduce anxiety is to pre medicate the child with certain medication, but this exposes the child to the adverse effects of these medicines and may prolong the duration of recovery. This is where the concept of non pharmacological methods to reduce pre operative anxiety comes In to the picture. Various non pharmacological methods which have been used earlier to decrease anxiety in children include parental presence at the time of induction. The aim is to make the child more acquainted with the surroundings or equipment used during anaesthesia induction. Hence the aim.of the study is to assess if pre operative exposure of children to the anaesthesia mask will improve their mask acceptance. We will also study whether this intervention reduces the anxiety during inhalational induction in this study population. |