| CTRI Number |
CTRI/2025/09/094114 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
EFFECT OF BIRDS IN REDUCING ANXIETY LEVEL IN CHILDREN DURING THEIR FIRST DENTAL VISIT |
|
Scientific Title of Study
|
Impact of Bird Assisted therapy in anxious pediatric dental patients during their first visit: A Randomized Control Trial |
| 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 BHAVANA DANDEKAR |
| Designation |
PG STUDENT |
| Affiliation |
Maitri college dentistry and research center, Anjora,Durg |
| Address |
302, department of pediatrics and preventive dentistry,Maitri college of dentistry and research center, Anjora, Durg, INDIA-491001
Durg
CHHATTISGARH
491001
India |
| Phone |
9131383163 |
| Fax |
|
| Email |
bhavana1998.kar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ADNAN AHMED |
| Designation |
READER AND GUIDE |
| Affiliation |
Maitri college dentistry and research center, Anjora,Durg |
| Address |
Maitri college of dentistry and research center, Anjora, Durg
Durg
CHHATTISGARH
491001
India |
| Phone |
09131383163 |
| Fax |
|
| Email |
adnanhavra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BHAVANA DANDEKAR |
| Designation |
PG STUDENT |
| Affiliation |
Maitri college dentistry and research center, Anjora,Durg |
| Address |
302, department of pediatric and preventive dentistry,Maitri college of dentistry and research center, Anjora, Durg
Durg
CHHATTISGARH
491001
India |
| Phone |
9131383163 |
| Fax |
|
| Email |
bhavana1998.kar@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. BHAVANA DANDEKAR, DEPARTMENT OF PEDIATRICS AND PREVENTIVE DENTISTRY AND RESEARCH CENTER, ANJORA, DURG.491001 |
|
|
Primary Sponsor
|
| Name |
302 Department of pediatrics and preventive dentistry |
| Address |
Maitri college of dentistry and research Center Anjora Durg |
| 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 Bhavana Dandekar |
Maitri college of dentistry and research center, Anjora ,Durg. |
302 Department of Pediatrics and preventive Dentistry
Durg
CHHATTISGARH |
9131383163
bhavana1998.kar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Maitri college of dentistry and research center. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young children between the age group of 4-8 years |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bird Assisted therapy |
Bird-assisted therapy will be carried out through visual and auditory exposure to chirping birds and change in anxiety levels will be observed pre and post dental treatment |
| Comparator Agent |
No treatment |
No additional treatment will be given in this group and change in anxiety levels will be observed pre and post dental treatment |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients experiencing first dental visit.
2.Children with positive or negative Frankel’s behaviour
3.Children with no learning disability.
4.The guardian or parents who granted written informed consent |
|
| ExclusionCriteria |
| Details |
1.Children with definitely positive or definitely negative Frankl’s behaviour.
2.Non-Cooperative patients that require additional behaviour management techniques during the
treatment will be excluded.
3.Children with visual and auditory impairment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the reduction in anxiety level among the patients following bird assisted therapy during their first dental visit between the age group of 4 to 8 years. |
To evaluate and compare the reduction in anxiety level among the patients following bird assisted therapy during their first dental visit between the age group of 4 to 8 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
02/09/2025 |
| 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="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
40 patients between the age group of 4 to 8 years will be selected for their first dental visit according to inclusion and exclusion criteria will be divided into 2 group with 20 patient in each group. Group I which is control group (without bird); and group-II (with birds). Child’s pre and post screening anxiety will be recorded using three parameters: Jeet Wheel Scale (JWS1 and JWS2), pulse rate (PR1 and PR2) using pulse oximeter and Modified Venham Clinical Anxiety (MVCAS1 and MVCAS2). Data will be obtained and statistically analysed. |