| CTRI Number |
CTRI/2015/05/005762 [Registered on: 08/05/2015] Trial Registered Retrospectively |
| Last Modified On: |
30/04/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
what are the factors that can influence anxiety in school going children prior to surgery |
|
Scientific Title of Study
|
ASSESSMENT OF FACTORS AFFECTING PRE-OPERATIVE ANXIETY IN SCHOOL GOING 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 Ritu |
| Designation |
Junior resident |
| Affiliation |
PGIMER |
| Address |
Department of Anesthesia and intensive care
PGIMER, Chandigarh
Department of Anesthesia and intensive care
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
08872010327 |
| Fax |
|
| Email |
drrituharshmalik29@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preethy Mathew |
| Designation |
Additional professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Additional professor
Department of Anesthesia and intensive care
PGIMER, Chandigarh
Additional professor
Department of Anesthesia and intensive care
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009530 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preethy Mathew |
| Designation |
Additional professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Additional professor
Department of Anesthesia and intensive care
PGIMER, Chandigarh
Additional professor
Department of Anesthesia and intensive care
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009530 |
| Fax |
|
| Email |
tjpreethy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PGIMER CHANDIGARH |
| Address |
PGIMER Chandigarh 160012
INDIA
|
| 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 |
| Dr Ritu |
PGIMER CHANDIGARH |
Advanced eye centre and
Advanced paediatric centre of PGIMER Chandigarh
Chandigarh
CHANDIGARH |
8872010327
drrituharshmalik29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTE EHICS COMMITTEE (INTRAMURAL) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1AND 2
Anxiety is measured and studied, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable , as its an observational study |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
7 TO 12 YEARS
ASA 1 AND 2 CHILDREN
SCHEDULED FOR ELECTIVE SURGERY UNDER GENERAL ANESTHESIA |
|
| ExclusionCriteria |
| Details |
DELAYED MILESTONES
CHILD NOT FULLY CONSCIOUS
NERODEVELOPMENTAL ANOMALIES
VISUAL IMPAIREMENT
EMERGENCY CASES
CHILDREN AND PARENTS/GUARDIANS WHO WERE UNABLE TO UNDERSTAND STAI QUESTIONNAIRE IN HINDI OR ENGLISH |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| FACTORS AFFECTING PRE-OPEATIVE ANXIETY |
Baseline , at the time of parental separation and at the time of induction |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of anxiety level at three stress points i.e baseline , at the time of parental separation and at the time of induction
Validation of appropriate cutoff for m-YPAS scale for indian setup |
Baseline
At the time of parental separation
At the time of induction |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Assessment of factors affecting preoperative anxiety in 7 to 12 years school going childrenCompared baseline preoperative anxiety with at the time of parental separation and at induction of anesthesia Validated appropriate cutoff for m-YPAS scale in INDIAN setup |