| CTRI Number |
CTRI/2023/12/060463 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
02/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effectiveness of Snake and Ladder Dental game on dental anxiety |
|
Scientific Title of Study
|
Effectiveness of Snake and ladder Dental game on Dental anxiety among 6 to 12 Year old children A Randomized controlled 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 |
Kavitha M |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry |
| Address |
Room No:22,
Department of Pediatric & Preventive Dentistry,
Mahatma Gandhi Post Graduate Institute of Dental Sciences
Govt of Puducherry Institution
Puducherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9597651757 |
| Fax |
|
| Email |
kavitham@mgpgi.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Kavitha M |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry |
| Address |
Department of Pediatric & Preventive Dentistry,
Mahatma Gandhi Post Graduate Institute of Dental Sciences
Govt of Puducherry Institution
Puducherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9597651757 |
| Fax |
|
| Email |
kavitham@mgpgi.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Kavitha M |
| Designation |
Assistant Professor |
| Affiliation |
Mahatma Gandhi Post Graduate Institute of Dental Sciences Govt of Puducherry Institution Puducherry |
| Address |
Department of Pediatric & Preventive Dentistry,
Mahatma Gandhi Post Graduate Institute of Dental Sciences
Govt of Puducherry Institution
Puducherry
Pondicherry PONDICHERRY 605006 India |
| Phone |
9597651757 |
| Fax |
|
| Email |
kavitham@mgpgi.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, MGPGIDS |
|
|
Primary Sponsor
|
| Name |
Kavitha M |
| Address |
MGPGIDS, Puducherry |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Kavitha M |
Dept of Pediatric & Preventive Dentistry,Mahatma Gandhi Post Graduate Institute of Dental Sciences |
Mahatma Gandhi Post Graduate Institute of Dental Sciences
Govt of Puducherry Institution
Puducherry Pondicherry PONDICHERRY |
9597651757
kavitham@mgpgi.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC MGPGIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children undergoing dental procedures |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
"Snake & ladder- Dental game†|
The child will be taken to the play area initially where “Snake and ladder-Dental game†will be given to the children to play for 15 minutes before the treatment.
The outcomes such as Anxiety level, Pulse rate and Oxygen saturation are measured at Baseline, 10 minutes of the procedure and 30 minutes of the procedure |
| Comparator Agent |
Control group |
The child will be taken directly taken to the dental operatory for treatment.
Anxiety level, Pulse rate, and oxygen saturation will be measured at Baseline, 10 minutes of the procedure and 30 minutes of the procedure
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children in the age group of 6 to 12 years reporting to the Department of Pediatric & Preventive dentistry MGPGIDS for dental treatment
Children willing to participate in the study
Children at first dental visit
|
|
| ExclusionCriteria |
| Details |
Medically compromised children
Children with special health care needs
Children with severe pain and facial swelling and trauma
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anxiety level, pulse rate, oxygen saturation |
Baseline, 10 mins, 30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="334" Sample Size from India="334"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/12/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Dental fear and anxiety is the most common and potentially distressing problem for both the patient and the dentist. Dental anxiety has been defined as an “abnormal fear or dread of visiting the dentist for preventive care or therapy and unwarranted anxiety over dental procedure. Dental anxiety during the procedure can have unwanted consequences, including uncontrollable behavior, lack of cooperation, and adverse psychological effects on the patients. It is important to control children’s behavior, gain their cooperation, and create a positive attitude about dental treatment. Due to the substantial effect of dental anxiety in pediatric patients, many pharmacological and non-pharmacological methods have been devised to alleviate or eliminate such anxieties of the patients. Due to the fondness for games in children, and also games are one such tool in reducing anxiety in children It has the found to be the most economical way to reduce anxiety in children needing dental treatments. Snake and ladder is an ancient game of India, originating in the Second century BC. It was originally used by religious teachers to teach children about the vary between good and bad - climbing up the ladders represents good, and sliding down the snakes represents bad. In this Snake and Ladder- Dental game the child will be able to know both “the positive and negative habits “about oral health and also in reducing anxiety. Nowadays in this current era, parents introduce mobiles for distraction reducing anxiety in children and also in a few studies, the dentist uses mobile games for distraction and reducing anxiety. The usage of smartphones and video games is harmful for children. Hence in this study, we planned to assess the Effectiveness of “Snake & ladder- Dental gameâ€, an indigenous game on Dental anxiety among 6–12-Year-old children before and after dental treatment. |