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CTRI Number  CTRI/2025/08/092213 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Use of light and eye massager in children during dental treatment 
Scientific Title of Study   Comparative evaluation of tech-enhanced comfort in pediatric dentistry:the impact of photobiomodulation and sensory stimulation on pain and anxiety 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanisha S 
Designation  Post graduate student 
Affiliation  AMES Dental college and hospital 
Address  Department of Pedodontics AMES dental college and hospital,raichur

Raichur
KARNATAKA
584103
India 
Phone  8105431324  
Fax    
Email  tanishasnayaka@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Raghavendra Havale 
Designation  Vice principal head and professor  
Affiliation  AMES Dental college and hospital 
Address  Department of Pedodontics AMES dental college and hospital,Raichur

Raichur
KARNATAKA
584103
India 
Phone  9448407300  
Fax    
Email  raghavendrahavale@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Tanisha S 
Designation  Post graduate student 
Affiliation  AMES Dental college and hospital 
Address  Department of Pedodontics AMES dental college and hospital,raichur

Raichur
KARNATAKA
584103
India 
Phone  8105431324  
Fax    
Email  tanishasnayaka@gmail.com  
 
Source of Monetary or Material Support  
AMES Dental college and Hospital Raichur Karnataka INDIA 584103 
 
Primary Sponsor  
Name  SELF  
Address  Dr Tanisha S Department of pedodontics and preventive dentistry AMES Dental college and hospital raichur karnataka 584103 
Type of Sponsor  Other [] 
 
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 Tanisha S  Department of Pedodontics and Preventive Dentistry  AMES Dental collge and Hospital,Raichur 584103
Raichur
KARNATAKA 
8105431324

tanishasnayaka@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  reducing anxiety and pain during dental procedure 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children aged 6 to 10 years old.
Children with first dental visit..
Children who need Local anaesthesia injection for their dental procedure.
Children with no prior exposure to dental anesthesia.
Children who do not have any neurological, psychological, or hearing impairments.
Children whose parents or guardians have provided informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  Children who refuse to wear the device.
Children experiencing severe or acute dental pain.
Children with a past history of systemic or psychiatric disorders.
Children with definitely negative rating on the Frankl Behavioral .
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in anxiety and pain in children during dental treatment using PBM and eye massager  BASELINE 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 4 
Date of First Enrollment (India)   01/08/2025 
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="0"
Months="6"
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  

This study will include 30 children aged 6–10 years attending their first dental visit at the Department of Pediatric and Preventive Dentistry. After enrollment, each child will be introduced to the operator and assessed for cooperative behavior using the Frankl Behavior Rating Scale to determine eligibility. Baseline measurements will be recorded, including subjective anxiety (RMS-PS) objective anxiety (Facial Image Scale) oxygen saturation and pulse rate.

Participants will be randomly divided into two groups (n  15). Group I will receive Periorbital Eye Massager (PEM) therapy with natural sounds, while Group II will undergo Intranasal Photobiomodulation (IPBM). A crossover design will be implemented, where each group receives the alternate intervention during the second visit.

Pain experienced during local anesthesia will be assessed using the Faces Pain Scale – Revised (FPS-R). Additionally, cooperative behavior, pulse rate, and oxygen saturation will be monitored before and after each procedure. Children’s anxiety will also be assessed pre- and post-operatively using a validated, language-appropriate questionnaire to ensure accurate and culturally sensitive reporting. All the obtained data will be statistically analysed using paired t test.

 
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