| CTRI Number |
CTRI/2024/03/063561 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
pilot study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of anxiety in chidren after showing instruments used for treatment |
|
Scientific Title of Study
|
Evaluation of Children’s Anxiety after showing instruments used in pediatric dentistry Procedures: A pilot Study |
| 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 Keval Vayeda |
| Designation |
Post graduate student |
| Affiliation |
College of Dental science and Hospital, Amargadh,Bhavnagar,Gujarat. |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Tal- Sihor, Dist- Bhavnagar
GUJARAT
364210
India
Bhavnagar
GUJARAT
364210
India |
| Phone |
7984868134 |
| Fax |
|
| Email |
kevalvayeda16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head of Department in Pediatric and preventive dentistry |
| Affiliation |
College of Dental science and Hospital, Amargadh,Bhavnagar,Gujarat. |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Tal- Sihor, Dist- Bhavnagar
364210
India
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shital Kiran D P |
| Designation |
Professor and Head of Department in Pediatric and preventive dentistry |
| Affiliation |
College of Dental science and Hospital, Amargadh,Bhavnagar,Gujarat. |
| Address |
Department of pediatric and preventive dentistry, Division P, Room No 6, College of Dental Science and Hospital, Bhavnagar Rajkot Highway, Amargadh Tal- Sihor, Dist- Bhavnagar
364210
India
Bhavnagar
GUJARAT
364210
India |
| Phone |
7016310949 |
| Fax |
|
| Email |
drskiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental science and Hospital Amargadh Bhavnagar 364210 |
|
|
Primary Sponsor
|
| Name |
College of Dental Science Amargadh Bhavnagar |
| Address |
College of Dental Science Amargadh Bhavnagar |
| 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 |
| Dr Keval Vayeda |
College of Dental Science |
College of Dental Science Pediatric and Preventive Dentistry Division P room no 6
Bhavnagar
GUJARAT
Bhavnagar
GUJARAT |
7984868134
kevalvayeda16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy children with no physical and mental retardation |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
1)Children of both gender aged 5-13 years.
2) Patients requiring/ Indication pulpectomy, Stainless steel crown, Space Maintainer
|
|
| ExclusionCriteria |
| Details |
1) Children who are medically compromised
2) Children who are physically and mentally Handicapped
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulse rate |
Just before showing instruments |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulse Rate |
Immediately after showing instruments |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
11/03/2024 |
| 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="3"
Days="0" |
|
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
|
Children of age
group 5-13 years who will be visiting to the Department of Pediatric and
Preventive Dentistry for Pulpectomy, Space Maintainer
and stainless steel crown will be divided into three different groups.
Children who require pulpectomy will be allotted to group 1, similarly subjects
who requiring Stainless steel crown will be allotted to group 2 and the sample which
require space maintainer will be allotted to group 3.
Group
1 – PULPECTOMY
Group
2 – STAINLESS STEEL CROWN
Group
3 – SPACE MAINTAINER
An informed Consent/Assent will be taken
from parents and procedure related to study will also be Explained. Anxiety
will be assessed just before showing the instruments and immediately after
showing instruments required for procedures of Pulpectomy, Space Maintainer and
stainless steel crown will be shown to the patient and it will be assessed with
Venham’s Picture scale and pulse oximeter
|