| CTRI Number |
CTRI/2025/02/081375 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Which is better in reducing dental anxiety among Tell play do with smart phone digital dentist game and Stress ball in children aged 6-10 years |
|
Scientific Title of Study
|
Comparative evaluation of Tell play do with smart phone digital dentist game and Stress ball in reducing anxiety in children aged 6-10 years: 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 |
Dr Chetan Zinzala |
| Designation |
Post Graduate Student |
| Affiliation |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat |
| Address |
Department of pediatric and preventive dentistry, division P, Room no.6, College of dental sciences,amargadh,Bhavnagar,Gujarat,364210,India
Bhavnagar GUJARAT 364210 India |
| Phone |
8153887596 |
| Fax |
|
| Email |
chetan.zinzala1305@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vikram Jhamb |
| Designation |
Professor Of The Department in Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat |
| Address |
Department of pediatric and preventive dentistry, division P, Room no.6, College of dental sciences,amargadh,Bhavnagar, Gujarat,364210,India
Bhavnagar GUJARAT 364210 India |
| Phone |
9620159058 |
| Fax |
|
| Email |
dr.vikramjhamb@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vikram Jhamb |
| Designation |
Professor Of The Department in Pediatric and Preventive Dentistry |
| Affiliation |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat |
| Address |
Department of pediatric and preventive dentistry, division P, Room no.6, College of dental sciences,amargadh,Bhavnagar, Gujarat,364210,India
Bhavnagar GUJARAT 364210 India |
| Phone |
9620159058 |
| Fax |
|
| Email |
dr.vikramjhamb@gmail.com |
|
|
Source of Monetary or Material Support
|
| College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat |
|
|
Primary Sponsor
|
| Name |
College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat |
| Address |
Department of pediatric and preventive dentistry,division P, Room no.6, College Of Dental Sciences, Amargadh, Bhavnagar, Gujarat-364210 |
| 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 Chetan Zinzala |
College of Dental Sciences, Amargadh, Bhavnagar, Gujarat |
Department of pediatric and preventive dentistry,division P, Room no.6, College of Dental Sciences, Amargadh, Bhavnagar, Gujarat-364210 Bhavnagar GUJARAT |
8153887596
chetan.zinzala1305@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
| Comparator Agent |
Group A (control group):Tell show do technique |
Tell show do technique will be used to reduce dental anxiety level.In this group, verbal explanation of the treatment procedure will be given to the child; the child will be explained exactly what is going to be done. After the explanation, demonstration of the visual, auditory, and tactile aspects of the procedure will be given to the child. The child will be shown all the instruments and materials required for the treatment, and the child will be made aware of the airotor noise. The child will also be shown how the airotor, three-way syringe, and suction work. Afterward, the child will be taken for the treatment, and the restorative procedure will be performed. This control group will take 25-30 minutes to assess anxiety before, during and after the treatment. |
| Intervention |
Group B (experimental group 1) : Tell play do with smart phone digital dentist game
|
Tell play do with smart phone digital dentist game will be used. In this technique, children will play a dentist game on a smartphone (Baby Panda Dental Care game) to learn about dental tools in a fun way for 5-10 minutes before starting the procedure. I will explain to the child everything that is shown in the game and participate in the activity by playing the game with the child to educate them about the dental treatment procedures, such as restorations, that will be performed on them. After that, the procedure will be started. This games ability to combine education with entertainment, along with its proven popularity and positive feedback from parents, makes it the most suitable choice for my study. Its rating is also better compared to other dentist games on the Play Store. This intervention will take 25-30 minutes to assess anxiety before, during and after the treatment. |
| Intervention |
Group C (experimental group 2): Stress ball |
Stress ball will be used.In this technique we will have 3 sizes (small,medium,large) of squeeze ball which will be shown to the children so they can choose one according to their comfort and before conducting the procedure children will be instructed to squeeze the ball for 5-10 minutes and after that procedure will be started. This intervention will take 25-30 minutes to assess anxiety before, during and after the treatment. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the age range of 6-10 years.
2. Children of both sexes.
3. Class I carious lesion on the primary molars who requiring a restoration without local anesthesia. |
|
| ExclusionCriteria |
| Details |
1.Children with special health care needs.
(Physically and mentally challenged).
2.Parents of children who refuse to give consent.
3.Extensively damaged teeth.
4.Teeth with lesions involving pulp. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess children anxiety |
Before, During and After the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in dental anxiety |
Variation of pulse measured using pulse oximeter before, during and after the procedure |
|
|
Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
18/08/2025 |
| 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="2" Months="0" Days="0" |
|
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
|
A randomized controlled trial will be carried out on 180 children aged 6-10 years who will be reporting to the Department of Pediatric and Preventive dentistry, College of Dental Sciences, Amargadh, Bhavnagar, Gujarat indicated for the treatment of class I restoration.Written informed consent will be taken before conducting the study. A total of 180 children will be taken for the study which will be divided in to 3 different groups. 60 children will be allocated to each group which will be divided in to: Group A (control group):Tell show do technique Group B (experimental group 1) : Tell play do with smart phone digital dentist game Group C (experimental group 2): Stress ball Group A (control group):Tell show do technique will be used to reduce dental anxiety level.In this group, verbal explanation of the treatment procedure will be given to the child; the child will be explained exactly what is going to be done. After the explanation, demonstration of the visual, auditory, and tactile aspects of the procedure will be given to the child. The child will be shown all the instruments and materials required for the treatment, and the child will be made aware of the airotor noise. The child will also be shown how the airotor, three-way syringe, and suction work. Afterward, the child will be taken for the treatment, and the restorative procedure will be performed. Group B (experimental group 1) : Tell play do with smart phone digital dentist game will be used. In this technique, children will play a dentist game on a smartphone (Baby Panda Dental Care game) to learn about dental tools in a fun way for 5-10 minutes before starting the procedure. I will explain to the child everything that is shown in the game and participate in the activity by playing the game with the child to educate them about the dental treatment procedures, such as restorations, that will be performed on them. After that, the procedure will be started. This game’s ability to combine education with entertainment, along with its proven popularity and positive feedback from parents, makes it the most suitable choice for my study. Its rating is also better compared to other dentist games on the Play Store. Group C (experimental group 2): Stress ball will be used.In this technique we will have 3 sizes (small,medium,large) of squeeze ball which will be shown to the children so they can choose one according to their comfort and before conducting the procedure children will be instructed to squeeze the ball for 5-10 minutes and after that procedure will be started. Samples in each group will be treated in a single appointment after using either of the behaviour modification techniques.Class I cavities will be prepared on carious primary molar and will be restored using Glass ionomer cement. This study is designed as a single blind (participants), randomized controlled trial with two parallel groups. Samples will be randomly allocated to the study groups by simple randomization by lottery method for equal distribution of sample size in study group. In this study Anxiety of the subject will be assesed before,during (immediately after cavity preparation) and after the treatment objectively by pulse rate with the help of pulse oximeter (by DR VAKU) and subjectively by chotta bheem chutki scale in all the three groups. CBC scale is a newly designed scale. This scale comprises two separate cards; one for boys and the other for girls.For boys, the Chotta Bheem cartoon character will be chosen to depict various emotions, and for girls, the Chutki cartoon character will be chosen to depict various emotions. Each card will consist of a series of six figures, ranging from happy to unhappy, with the cartoon character displaying different emotions. Children will be asked to choose the face they identify with at that moment. To record on the scale, a score of one will be assigned to the happy face, and six will be assigned to running. |