| CTRI Number |
CTRI/2025/03/083750 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
A Three-Way Comparison of strategies to reduced anxiety among kids : Play-Based on Learning, Virtual game and Snoezelen Therapy |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of Tell-Play-Do and Virtual game and Snoezelen environment to evaluate behavior and anxiety in 4-7 years old children
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Dnyaneshwar Hagwane |
| Designation |
Post graduate student |
| Affiliation |
Pacific dental college and hospital Debari Udaipur |
| Address |
Pacific dental college and hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
07447473539 |
| Fax |
|
| Email |
aditihagwane98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh Rao |
| Designation |
HOD PG guide |
| Affiliation |
Pacific dental college and hospital Debari Udaipur |
| Address |
Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh Rao |
| Designation |
HOD PG guide |
| Affiliation |
Pacific dental college and hospital Debari Udaipur |
| Address |
Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Dental College And Hospital, Debari, udaipur, 313024 |
|
|
Primary Sponsor
|
| Name |
Aditi Hagwane |
| Address |
Girls hostel no 1,Pacific dental college and hospital, Debari ,Udaipur 313024 |
| 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 |
| Dr Aditi Hagwane |
Pacific Dental College And Hospital Debari Udaipur 313024 |
Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024
Udaipur
RAJASTHAN |
07447473539
aditihagwane98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional research review board (Pacific dental college and hospital debari udaipur 313024 rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Snoezelen environment |
it will be use for 2 months for first appointment
The child along with
parents were made to enter the room which is converted into
Snoezelen effect that is combination of a partially lit room
with special lighting effects, relaxing music, and aromas.
This environment provides sensory stimulation to children
during the treatment. |
| Comparator Agent |
tell-play-do |
uses a "learning by doing" approach to reduce dental anxiety in children by first explaining the procedure, then allowing them to practice with toy instruments, and finally performing the actual treatment. |
| Comparator Agent |
Virtual Game |
A smart phone is given to
subjects which contain dental related mobile game in the
presence of parents. The game consist of variety of dental
stimulated treatments which the child could play during the
treatment. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Children of age four to seven years
Children who are coming for their first dental visit
Children who fall under negative Frankl’s behavior
rating scale
Children who fall under sad and very sad facial image
scale |
|
| ExclusionCriteria |
| Details |
Children who are physically, mentally and medically compromised
Patient requiring emergency treatment
Parents who are willing to allow their child to
participate
Children who are not willing to enter the Snoezelen
environment (for example: autistic children) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
virtual games and Snoezelen
environment is effective in reducing the dental anxiety in
children aged 4 - 6 years during their first dental visit |
it will be assesed in first appointment before and after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
virtual games & Snoezelen
environment is effective in reducing the dental anxiety even tell play do also effective to reduce there anxitey in
children aged 4 - 7 years during their first dental visit |
it will be assesed in first appointment before & after procedure |
|
|
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)
|
06/04/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dental anxiety (DA) is a feeling of fear that something frightful will occur during dental treatment. It is associated with a sense of losing control. Anxiety is a complex construct with physical, cognitive, and emotional components. The prevalence of dental anxiety is 5 - 20 % in most of the populations which are seen more in children, and this tends to decrease as age advances [54, 55]. Our study aimed to assess and compare the effectiveness of virtual games and the Snoezelen environment on dental anxiety levels with conventional Tell - Show - Do in children aged 4 - 7 years. Among the different nonpharmacological treatments, sensory adapted dental environment (SADE) is a unique therapy approach that has become increasingly popular. The "Snoezelen chamber," which is a well - lit room with slow - moving light, soothing sound, and precise tactile feeling, is typically where this multisensory - stimulating environment is presented. Different functions were fulfilled by these multisensory stimuli. The first step was to partially dim the room to resist any unpleasant visual sensations. To distract the kids from the usual loud sounds of the dental equipment, pleasant music was played in the background to mask the second sensory stimulus, which is the "noise" (e. g., airotor and suction). An aroma diffuser was utilised to mask the "smell, " which is the third sensory stimulus, by removing the characteristic hospital odour. |