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CTRI Number  CTRI/2025/02/080268 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Acupressure And Virtual Reality Distraction For Anxiety Reduction In Children Aged 8-12 Yrs  
Scientific Title of Study   Comparative Evaluation Of Acupressure And Virtual Reality Distraction For Anxiety Reduction In Children Aged 8-12 Yrs – 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 Kanchan M Tuppadmath 
Designation  Assistant professor 
Affiliation  AMEs dental college and hospital 
Address  Department of Pedodontics and Preventive Dentistry, Room NO. 04, A M Es Dental College and Hospital Near Government Polytechnic college Bijjanegera Road Raichur Raichur KARNATAKA 584103 India

Raichur
KARNATAKA
584103
India 
Phone  9686984929  
Fax    
Email  kanchantuppadmath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghavendra Havale 
Designation  Professor and Head 
Affiliation  AMEs dental college and hospital 
Address  Department of Pedodontics and Preventive Dentistry, Room NO. 04, A M Es Dental College and Hospital Near Government Polytechnic college Bijjanegera Road Raichur Raichur KARNATAKA 584103 India

Raichur
KARNATAKA
584103
India 
Phone  9448407300  
Fax    
Email  raghavendrahavale@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Kanchan M Tuppadmath 
Designation  Assistant professor 
Affiliation  AMEs dental college and hospital 
Address  Department of Pedodontics and Preventive Dentistry, Room NO. 04, A M Es Dental College and Hospital Near Government Polytechnic college Bijjanegera Road Raichur Raichur KARNATAKA 584103 India

Raichur
KARNATAKA
584103
India 
Phone  9686984929  
Fax    
Email  kanchantuppadmath@gmail.com  
 
Source of Monetary or Material Support  
AME dental college and Hospital, Bijjanagera road, near govt polytechnic college, Raichur, karnataka- India 584103 
 
Primary Sponsor  
Name  Dr Kanchan M Tuppadmath  
Address  A M Es Dental College and Hospital Bijanegera Road Near government polytechnic college Raichur , karnataka- India 584103 
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 Kanchan M Tuppadmath  AMEs Dental college and hospital, Raichur, Karnataka- India  Out Patient Department, Department of Pedodontics and Preventive Dentistry, Room no.6
Raichur
KARNATAKA 		 9686984929

kanchantuppadmath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe of A M Es Dental College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F418||Other specified anxiety disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  acupressure  Acupressure beads (natural vaccaria seeds with adhesive tape) are used .These will be applied anxiety reducing acupoints. These beads are used to check their ability on dental anxiety reduction in children 
Comparator Agent  virtual reality distraction googles  virtual reality distraction goggles are used where the child can view video playing in 3D format. This device blocks the view and sound which helps to reduces anxiety during dental treatment T 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children aged 8-12 years, requiring administration of local anesthesia irrespective of treatment with a Frankl’s rating 2 and 3 and good general health (American society of Anaesthesiology I)  
 
ExclusionCriteria 
Details  children with special health care needs, medically compromised and who have history of anxiety disorders and phobia  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
evaluate and compare effect of acupressure and virtual reality distraction on anxiety levels in children receiving local anesthesia in dental setting.   for acupressore- 45 minutes before local anesthetia, 5 minutes after local anesthesia and 15 minutes after treatment completed 
 
Secondary Outcome  
Outcome  TimePoints 
side effects following intervention with acupressure and virtual reality distraction  15 minutes after treatment procedure is complete 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2/ Phase 3 
Date of First Enrollment (India)   19/02/2025 
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="0"
Days="10" 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 27-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Background: Anxiety is an obstacle during dental treatment in children. Acupressure and Virtual reality distraction (VRD) are the newer behaviour modification techniques currently gaining popularity in clinical Pediatric Dentistry. The purpose of this study is to compare the effect of acupressure and VRD on anxiety in children.

Methods: A total of 60 children aged 8-12 years meeting inclusion criteria will be randomly and equally divide into acupressure (group I) and VRD group (group II). Acupressure group is further subdivided into three groups with 10 subjects in each subgroup based on the acupoints selected (EX-HN3, Shen Men, P6). Acupressure beads with adhesive strip will be employed over the selected acupoints for group I and VRD glasses playing cartoons will be put on for group II. Anxiety will be measured at four different time intervals i.e at baseline, forty minutes after application of acupressure in group I and five minutes after using virtual reality device in group II, five minutes after local anesthesia, lastly fifteen minutes after completion of treatment. Modified child dental anxiety scale faces version (MCDAS [F]) was used for subjective assessment, Venham’s clinical anxiety rating scale (VCRS) for objective assessment and pulse rate (PR) as physiologic assessment. 
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