| CTRI Number |
CTRI/2018/03/012631 [Registered on: 19/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess various pre-disposing factors that influence the anxiety of children before surgery. |
|
Scientific Title of Study
|
Assessment of factors affecting pre-operative anxiety in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arun M G |
| Designation |
Junior Resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9980001916 |
| Fax |
|
| Email |
arunmgraghu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preethy J Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417800203 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preethy J Mathew |
| Designation |
Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care,
Postgraduate Institute of Medical Education and Research (PGIMER)
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9417800203 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, PGIMER, Chandigarh |
| 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 |
| Preethy J Mathew |
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh |
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
7087009530
tjpreethy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER thesis committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Children undergoing elective surgery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Scheduled for an elective procedure under general anaesthesia
Belonging to ASA physical status I or II.
Both in-patients and ambulatory patients were included |
|
| ExclusionCriteria |
| Details |
The children with following conditions:
1.Decreased state of consciousness
2.Delay in milestones
3.Psychiatric illness
4.Neurodevelopment anomalies
5.Visual impairment
6.Known hypersensitivity to benzodiazepines
7.Those whose parents were unable to answer STAI questionnaire in English or Hindi.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pre-op anxiety in children |
Pre-op room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Predictors of pre-op anxiety in children |
Pre-op room |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/11/2011 |
| Date of Study Completion (India) |
30/09/2012 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
An observational study was conducted to identify the factors affecting pre-operative anxiety in children and to correlate the baseline anxiety with anxiety at parental separation and at induction. One or both parent/s accompanying the child completed state part of the STAI to assess parental anxiety. Data was also collected on various possible predictors of anxiety like- age, father’s and mother’s education, age of the father and the mother, number of siblings and birth order, history related to previous exposure to surgery, age at previous surgery, whether the child has been seen in the PAC clinic and the number of persons accompanying the child to the hospital. The socioeconomic status of the parents was assessed using Aggarwal’s scale. The temperament of the children was measured using Temperament Measurement Schedule.Child’s anxiety was measured using the modified Yale Pre-operative Anxiety scale (m-YPAS) at 3 stress points- baseline, parental separation and at induction. |