| CTRI Number |
CTRI/2023/11/060361 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Animated Video and Verbal Communication in Reducing Dental Anxiety in Children using Children drawing hospital manual |
|
Scientific Title of Study
|
A Comparative Evaluation of Animated Video and Verbal Communication as a Preoperative Intervention in Reducing Dental Anxiety in Children using CD:H, Pulse rate and Facial Image Scale. |
| 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 Shagorika choudhury |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D.Y. Patil Deemed to be University, School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai, Thane, Maharashtra. 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
8788130221 |
| Fax |
|
| Email |
shagorika.choudhury6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa S. Naik |
| Designation |
Professor and Head of Department |
| Affiliation |
Dr. D.Y. Patil Deemed to be University, School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai, Thane, Maharashtra. 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
9769600440 |
| Fax |
|
| Email |
shilpa.naik@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shagorika Choudhury |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D.Y. Patil Deemed to be University, School of Dentistry |
| Address |
Department of Pediatric and Preventive Dentistry, Dr. D.Y. Patil
Deemed to be University, School of Dentistry, Sector 7, Highway
Road, Nerul, Navi Mumbai, Thane, Maharashtra. 400706
Thane
MAHARASHTRA
410210
India |
| Phone |
8788130221 |
| Fax |
|
| Email |
shagorika.choudhury6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry Dr. D.Y. Patil Deemed to be University, School
of Dentistry, Sector 7, Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatric and Preventive Dentistry |
| Address |
Dr. D.Y. Patil Deemed to be University, School of Dentistry, Sector 7,
Highway Road, , Nerul, Navi Mumbai, Thane, Maharashtra. 400706 |
| 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 Shagorika Choudhury |
Postgraduate clinic, Department of Pediatric and Preventive Dentistry |
Dr. D.Y. Patil Deemed
to be University, School
of Dentistry, Sector 7,
Highway Road, , Nerul,
Navi Mumbai, Thane,
Maharashtra. 400706
Thane
MAHARASHTRA
Thane
MAHARASHTRA |
8788130221
shagorika.choudhury6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research and ethical board, D. Y. Patil Deemed to be University School of Dentistry, Navi Mumbai. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Animated Video |
Animated video of the dental procedure that has to be shown to the participant before the
particular procedure is carried out |
| Comparator Agent |
Tell-Show-Do technique |
Tell-Show-Do method, participant decribed the dental procedure to be carried out. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children Aged 6-8 years old as they were likely to have the cognitive ability and motor skills to self-report their anxiety.
2. Children without previous dental treatment experience.
3. Children with teeth which require only oral prophylaxis, pit and fissure sealants, fluoride application and minimally invasive restoration diagnosed according to ICDAS (score 2-3)
4. Children with moderate to severe anxiety as per (Modified Dental Anxiety Scale)
|
|
| ExclusionCriteria |
| Details |
1.Children whose parents did not give consent for the study.
2.Children who refused to draw a picture.
3. Children who are medically compromised |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulse rate ,Facial Image Scale , Drawing Score(CD:H) |
At Baseline, During procedure, After procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation between Drawing Score (CD:H) & Pulse Rate |
At Baeline, During Procedure, After Procedure |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/12/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
aim:To compare
and evaluate the effect of visual information and verbal communication as
a pre-operative intervention in reducing
level of anxiety among children aged 6-8 years old undergoing dental treatment using CD:H, pulse
rate and facial image scale.
Methodology:
Children who fulfilled inclusion criteria after initial examination were
divided into two groups:
Group A-
children subjected to animated video as pre-operative intervention. Group B
children subjected to tell show do as pre-operative intervention. After
the intervention on the first day after
examination children in both the groups will be asked to draw (1st drawing).
To
understand the effectiveness of interventions, on the first appointment
objective anxiety signs with a pulse
oximeter and subjective anxiety with Facial Image Scale will be recorded at three stages: baseline, during treatment and
post treatment. Post treatment the child will be asked to draw (2nd drawing) which will be then
analysed by a child psychologist. |