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CTRI Number  CTRI/2019/04/018768 [Registered on: 24/04/2019] Trial Registered Prospectively
Last Modified On: 12/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of distraction method in comparison to routine method of guiding behavior of child patient while giving injection for numbing pain 
Scientific Title of Study   Effectiveness of an active and passive distraction technique on the anxiety, behavior and pain levels of children while administering local anesthesia: a randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shrehya Shekhar 
Designation  Post graduate 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Room No. 5, Department of Pedodontics and Preventive Dentistry,Manipal College of Dental Sciences, Light House Hill Road, Mangalore, Karnataka- 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9176392221  
Fax    
Email  shrehyashekhar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shrehya Shekhar 
Designation  Post graduate 
Affiliation  Manipal College of Dental Sciences, Mangalore 
Address  Room No. 5,Department of Pedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Light House Hill Road, Mangalore, Karnataka- 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9176392221  
Fax    
Email  shrehyashekhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Suprabha B S 
Designation  Head of Department  
Affiliation  MANIPAL COLLEGE OF DENTAL SCIENCES 
Address  Room No. 5,Department of Pedodontics and Preventive Dentistry,Manipal College of Dental Sciences, Light House Hill Road, Mangalore, Karnataka- 575001

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9480655538  
Fax    
Email  sprbhbhat@yahoo.co.in  
 
Source of Monetary or Material Support  
Self Funding, Shrehya Shekhar, Room no. 5, Department of Pedodontics and Preventive Dentistry, Manipal College of Dental Sciences, Light House Hill Road, Mangalore, Karnataka- 575001 
 
Primary Sponsor  
Name  Shrehya Shekhar 
Address  Room no. 5, Manipal college of dental sciences, Light house hill road, Mangalore- 575001 
Type of Sponsor  Other [Self funding] 
 
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 
Shrehya Shekhar  Manipal College of dental sciences  ROOM NUMBER 5,DEPARTMENT OF PEDODONTICS AND PREVENTIVE DENTISTRY,MANIPAL COLLEGE OF DENTAL SCIENCES, LIGHT HOUSE HILL ROAD, MANGALORE, KARNATAKA-575001
Dakshina Kannada
KARNATAKA 		 9176392221

shrehyashekhar@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  ● Children who require extraction/pulp therapy/restoration for deep carious lesion treatment in lower primary and first permanent molars under local anesthesia . 
Patients  (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  To evaluate and compare the effectiveness of stress ball(active) distraction technique and audiovisual distraction (passive) technique and conventional behavior guidance technique on the pain, behavior and anxiety levels during administration of inferior alveolar nerve block.  Children will be divided into 3 groups namely active distraction which is stress ball, passive distraction which is Virtual reality glasses, and conventional behavior guidance method which is positive reinforcement and euphemisms during the administration of inferior alveolar nerve block. 
Intervention  To evaluate and compare the effectiveness of stress ball(active) distraction technique and audiovisual distraction (passive) technique and conventional behavior guidance technique on the pain, behavior and anxiety levels during administration of inferior alveolar nerve block.  Group 1: active distraction using stress ball technique 
Intervention  To evaluate and compare the effectiveness of stress ball(active) distraction technique and audiovisual distraction (passive) technique and conventional behavior guidance technique on the pain, behavior and anxiety levels during administration of inferior alveolar nerve block.  Group 2: Passive distraction technique using Virtual reality glasses 
Intervention  To evaluate and compare the effectiveness of stress ball(active) distraction technique and audiovisual distraction (passive) technique and conventional behavior guidance technique on the pain, behavior and anxiety levels during administration of inferior alveolar nerve block.  Group 3 : Conventional technique using euphemisms and positive reinforcement 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children with a score of ≥12 on faces version of Modified Child Dental Anxiety Scale.
2. Children who could be categorized under positive (+) ratings of Wright’s modification of Frankl behavior rating scale (Wright and Stigers 2011).
3. Children who require extraction/pulp therapy/restoration for deep carious lesion treatment in lower primary and first permanent molars under local anesthesia (inferior alveolar nerve block).
 
 
ExclusionCriteria 
Details  1.Children suffering from any systemic and/or mental illness.
2.Children whose parents do not give written informed consent or children who do not give assent for the study
3.Children who have undergone any dental treatment under local anesthesia in the past 6-7 weeks.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Dental anxiety of the child to be measured before and after the administration of Inferior alveolar nerve block using Modified Child Dental anxiety scale faces version [MCDAS(f)].  Before and after the administration of Inferior alveolar nerve block using Modified Child Dental anxiety scale faces version [MCDAS(f)]. 
 
Secondary Outcome  
Outcome  TimePoints 
Behavior and pain of the child to be measured before and after the administration of Inferior alveolar nerve block using Venham Behaviour rating scale and Wong Baker and FLACC scale respectively.  Before and after the administration of Inferior alveolar nerve block. 
 
Target Sample Size   Total Sample Size="123"
Sample Size from India="123" 
Final Enrollment numbers achieved (Total)= "123"
Final Enrollment numbers achieved (India)="123" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   08/05/2019 
Date of Study Completion (India) 26/02/2021 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 Aim:
 To evaluate and compare the effectiveness of stress ball(active) distraction technique and audiovisual eyeglasses (passive) distraction technique on the pain, behavior and anxiety levels during administration of inferior alveolar nerve block.
Objective: 
1. To evaluate the change in the behavior, anxiety and pain levels in children after the use of the distraction techniques during the administration of inferior alveolar nerve block. 
2. To compare the behavior, anxiety and pain levels between the children after use of active and passive distraction techniques during the administration of inferior alveolar nerve block.
Methodology:
All procedures were done in the presence of parents/guardians. In order to acclimatize the child to the dental clinic, basic behaviour guidance techniques like communication, tell-show-do, and verbal reinforcement were for all the participants.  The
children were randomly assigned to one of the groups using block randomization method with 1:1:1 allocation ratio:
Group 1: Conventional method of Communication
Group 2: Virtual Reality glasses
Group 3: Stress ball
Prior to administration of the local anesthetic agent, dental anxiety of the child was measured using the MCDAS(f) scale. Behavior was assessed during the entire length of the procedure using the Venham behavior scale. Each child was asked to quantify the pain felt during the injection using the Wong-Baker faces pain rating scale. The pain reaction was also recorded by an observer using FLACC scale ( Faces Legs Activity Cry and Consolability scale). The variations in the pulse rate was recorded using pulse oximeter, at three time points: just before starting the administration of the local anesthetic, during the injection of the local anesthetic and soon after the removal of the needle from the tissue. Scoring for behavior and pain was  done using a video recording of the procedure by two examiners.  
A questionnaire consisting of questions on the history of earlier dental visit (first visit or not), past dental and medical experiences of the child, socioeconomic status, parental anxiety and temperament of the child was administered to the accompanying parent prior to the procedure.
Results and Conclusions: There was no significant difference between the groups for all the outcomes (dental anxiety, behaviour and pain levels). Significant decrease in anxiety was seen within all the groups after the behaviour guidance. The effect of passive distraction (AV eyeglasses) and active distraction (stress ball) on the anxiety, behaviour and pain levels during administration of the inferior alveolar nerve block are comparable to the conventional behaviour guidance methods.


 
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