| CTRI Number |
CTRI/2023/03/050551 [Registered on: 10/03/2023] Trial Registered Prospectively |
| Last Modified On: |
09/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
DENTAL ANXIETY AND ART THERAPY |
|
Scientific Title of Study
|
A study to assess the dental anxiety among the children undergoing dental treatment with help of their drawings and art therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitali Mirajkar |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College Hospital Aurangabad |
| Address |
Department of Pediatric Dentistry, Room Number 217, Second floor, Government Dental College and hospital Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9422284546 |
| Fax |
|
| Email |
chaitalikmirajkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Umesh Hambire |
| Designation |
Professor |
| Affiliation |
Government Dental College Hospital Aurangabad |
| Address |
Department of Pediatric Dentistry, Room Number 217, Second floor, Government Dental College and hospital Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9325212382 |
| Fax |
|
| Email |
umeshvhambire@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chaitali Mirajkar |
| Designation |
Assistant Professor |
| Affiliation |
Government Dental College Hospital Aurangabad |
| Address |
Department of Pediatric Dentistry, Room Number 217, Second floor, Government Dental College and hospital Aurangabad
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
9422284546 |
| Fax |
|
| Email |
chaitalikmirajkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Chaitali Keshav Mirajkar
17, Shreekunj, Samadhan colony, Behind Sessions court, Aurangabad-431001 |
|
|
Primary Sponsor
|
| Name |
Government Dental College and hospital Aurangabad |
| Address |
Government Medical college Aurangabad campus, Panchakki Road, Aurangabad |
| Type of Sponsor |
Government 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 Chaitali Hambire |
Government Dental College and hospital Aurangabad |
Department of Pediatric Dentistry, Room Number 217,second floor, Government Dental College and hospital Aurangabad
Aurangabad
MAHARASHTRA |
9422284546
chaitalikmirajkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , Government Dental College and hospital Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F432||Adjustment disorders, (2) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dental treatment under local anesthesia |
2% Lignocaine hydrochloride with 10.000 adrenaline as intra oral dental anesthesia. No art therapy is given but only routine dental treatment |
| Intervention |
Dental Treatment under local anesthesia followed by art therapy |
2%lignocaine hydrochloride with 10,000 adrenaline given as intra oral dental anesthesia followed by art therapy in form of connect the numbers and color the pages with drawing |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1) 6-12 years of age-independent of sex, and ethnic characteristics
2) Children without previous dental treatment experience
3) Children with carious primary teeth which required pulp therapy and restorative treatment
4) Children who are not considered medically compromised
5) Obtained written informed consent from parents or caregivers and obtained verbal informed consent from the child for their participation in the study where procedures are explained in an age-appropriate attitude
6) Children who accept to draw a picture
|
|
| ExclusionCriteria |
| Details |
1) Children with a compromised physical and mental health history . 2) Children who already received dental treatments
3) Children who only needed preventive treatments
4) Children who reject to draw a picture
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Drawings can be used as a tool to assess the presence of dental anxiety and art therapy effectively reduces the anxiety in pediatric patients undergoing dental treatment.
|
4 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Art therapy reduces the dental anxiety |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/03/2023 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - After publication of the study the published article will be provided
- For how long will this data be available start date provided 01-08-2023 and end date provided 01-08-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Abstract-Assessment of dental anxiety in children is difficult because of their immature cognitive and emotional development. Art therapy utilizes creative therapy interventions to deal with children suffering from emotional problems. Aims and objectives: (1) To assess the drawings of children for the presence of dental anxiety. (2) To assess the influence of art therapy on the dental anxiety in the children. Methodology: 120 children within the age group of 6-12 years participated in this study. The pretest and post test objective assessment of dental anxiety was done using Frankl and Five facial anxiety scale. All the participants received local anesthesia during their first treatment session. All the children were asked to draw a picture of their treatment experience at the end of the session. The drawings were assessed by a psychologist. Simple random sampling technique was used for allotting 60 children into study group and 60 children into control group. Art therapy was given to 60 children in the study group for three consecutive appointments. Results: There was a significant reduction in the anxiety in study group and a significant correlation between the objective score of dental anxiety and the subjective scores of CD: H and HFD. Conclusion: Drawings can be used as a tool to assess the presence of dental anxiety and art therapy effectively reduces the anxiety in pediatric patients undergoing dental treatment. |