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CTRI Number  CTRI/2024/09/074369 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 29/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How stress balls fidget spinners and videos help reduce gag reflex and anxiety in children aged 5 to 12 years. 
Scientific Title of Study   Effectiveness Of Stress Ball, Spin Fidget And Audio Visual Aid In Gag Reflex Suppression And Anxiety Management In 5-12 Years Children - A Randomized Control 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 Harshmeet Kour Melody 
Designation  Post Graduate 
Affiliation  Mahirishi Markandeshwar College of Dental Science and Research 
Address  Department of Pediatric and Preventive Dentistry,Mahirishi Markandeshwar College of Dental Science and Research , Mullana , Ambala

Ambala
HARYANA
133207
India 
Phone  9541568420  
Fax    
Email  hkmelody4444@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mansi Jain 
Designation  Professor 
Affiliation  Mahirishi Markandeshwar College of Dental Science and Research 
Address  Department of Pediatric and Preventive Dentistry ,Mahirishi Markandeshwar College of Dental Science and Research , Mullana , Ambala

Ambala
HARYANA
133207
India 
Phone  9882600156  
Fax    
Email  mansi.jain@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr HARSHMEET KOUR MELODY 
Designation  Post Graduate 
Affiliation  Mahirishi Markandeshwar College of Dental Science and Research 
Address  Department of Pediatric and Preventive Dentistry,Mahirishi Markandeshwar College of Dental Science and Research , Mullana , Ambala

Ambala
HARYANA
133207
India 
Phone  06380971425  
Fax    
Email  hkmelody4444@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana , India - 133207 
 
Primary Sponsor  
Name  Dr Harshmeet Kour Melody 
Address  Department of Pediatric and Preventive Dentistry, Maharishi Markandeshwar College of Dental Sciences and Research, Mullana, Ambala, Haryana. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshmeet Kour Melody  Maharishi Markandeshwar College of Dental Sciences And Research   Room Number 4, Department of Pediatric and Preventive Dentistry
Ambala
HARYANA 		 9541568420

hkmelody4444@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences and Research, Mullana, Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R458||Other symptoms and signs involvingemotional state,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Interaction  Interactive distraction session is done for 10 minutes  
Intervention  Stress ball, Spin fidget and audio visual aid  Stress ball, Spin fidget and audio visual aid is used as distraction method for 10 minutes 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Children between 5-12 years of age 2.Children without systemic health conditions.3. Patient with no previous dental experience.
4. Children requiring alginate impression for any dental procedure.5.Co-operative patient with Gagging Severity grading 1, 2 and 3. 
 
ExclusionCriteria 
Details  1.Children with severe cognitive impairments.2.Children with physical limitations. 3.Children with respiratory problems. 
 
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 
Reduction of gag reflex and anxiety  15 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
management of behavior  15 minutes 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/10/2024 
Date of Study Completion (India) 23/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [hkmelody4444@gmail.com].

  6. For how long will this data be available start date provided 20-09-2024 and end date provided 20-09-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  
This study is a randomized controlled trial , single blinded trial comparing the EFFECTIVENESS OF STRESS BALL, SPIN FIDGET AND AUDIO VISUAL AID IN GAG REFLEX SUPPRESSION AND ANXIETY MANAGEMENT IN 5-12 YEARS CHILDREN . Patients that was conducted in Department of Pediatric and Preventive Dentistry , MMCDSR , Mullana , Haryana with the sample size of 76. 

In the present study, Spin Fidget and Stress Ball emerged as the most effective modalities, demonstrating comparable performance and yielding the most favorable clinical outcomes evidenced by lower GSI scores, GPI scores indicating greater reduction in anxiety levels. The Audio-Visual Aid group demonstrated moderate effectiveness across these parameters, whereas Interactive Distraction exhibited the least desirable outcomes, indicating comparatively limited efficacy in gag reflex suppression and anxiety control.


 
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