| CTRI Number |
CTRI/2020/04/024595 [Registered on: 13/04/2020] Trial Registered Prospectively |
| Last Modified On: |
09/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
TO COMPARE INCIDENCE OF PARENTAL ANXIETY IN ACTIVE AND CONTROL GROUP |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
COMPARATIVE STUDY OF THE EFFECT OF VIDEO BASED VERSUS CONVENTIONAL PREOPERATIVE PREPARATION ON PARENTAL ANXIETY IN PAEDIATRIC DENTAL PROCEDURES UNDER GENERAL ANAESTHESIA |
|
Scientific Title of Study
|
TO STUDY THE EFFECT OF VIDEO BASED PREOPERATIVE PREPARATION ON PARENTAL ANXIETY IN CHILDREN UNDERGOING DENTAL PROCEDURES UNDER GENERAL ANAESTHESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NSIVAPHANEENDRA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER |
| Address |
PGIMER
DEPARTMENT OF ANAESTHESIA
NEHRU HOSPITAL,LEVEL-5
CHANDIGARH-160012
DEPARTMENT OF ANAESTHESIA
NEHRU HOSPITAL
LEVEL-5
CHANDIGARH-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09885980568 |
| Fax |
01722686677 |
| Email |
nsp71955@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
INDUMOHINISEN |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANAESTHESIA
ADVANCED PAEDIATRIC CENTRE
PGIMER
CHANDIGARH
HOUSENO-5439
SECTOR-38 WEST
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209532 |
| Fax |
01722686677 |
| Email |
indumohini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
INDUMOHINISEN |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER |
| Address |
DEPARTMENT OF ANAESTHESIA
ADVANCED PAEDIATRIC CENTRE
PGIMER
CHANDIGARH
HOUSENO-5439
SECTOR-38 WEST
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209532 |
| Fax |
01722686677 |
| Email |
indumohini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF ANAESTHESIAPGIMERCHANDIGARH |
| Address |
PGIMER
CHANDIGARH-12 |
| Type of Sponsor |
Research institution |
|
|
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 SIVAPHANEENDRA |
PGIMER |
ORAL HEALTH SCIENCES
ROOM NO-202
Chandigarh
CHANDIGARH |
9885980568
nsp71955@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE,PGIMER,CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
COMPARATIVE STUDY OF THE EFFECT OF VIDEO BASED VERSUS CONVENTIONAL PREOPERATIVE PREPARATION ON PARENTAL ANXIETY IN PAEDIATRIC DENTAL PROCEDURES UNDER GENERAL ANAESTHESIA |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
AGE 2-6YEARS
ASA 1-3
DAY CARE PATIENTS |
|
| ExclusionCriteria |
| Details |
PARENT/GUARDIAN REFUSE TO PARTICIPATE
INABILITY TO UNDERSTAND QUESTIONNAIRE
DENTAL EMERGENCIES |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECT OF VIDEO BASED VERSUS CONVENTIONAL PREOPERATIVE PREPARATION ON INCIDENCE OF ANXIETY USING APAIS SCALE IN PARENTS OF PAEDIATRIC DENTAL PROCEDURES UNDER GENERAL ANAESTHESIA |
FIRST BEFORE SURGERY AND SECOND AFTER SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE AIRWAY EVENTS,VOMITING ANY OTHER COMPLICATIONS OF GENERAL ANAESTHESIA |
POST OPERATIVE SURGERY UP TO TWO HOURS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
14/04/2020 |
| 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="7"
Days="2" |
|
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
|
TO COMPARE OF PARENTAL ANXIETY IN TWO GROUPS AND IMPROVEMENT IN ANXIETY SCORES IN VIDEO BASED INTERVENTION GROUP. |