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CTRI Number  CTRI/2022/09/045796 [Registered on: 23/09/2022] Trial Registered Prospectively
Last Modified On: 20/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of a Muscle Relaxation Technique and Relaxing sounds to conventional behvaviour management techniques to reduce anxiety in children undergoing invasive dental procedures 
Scientific Title of Study   Comparison of Progressive Muscle Relaxation and Autonomous Sensory Meridian Response to conventional behaviour management techniques in anxious children undergoing invasive dental procedures  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dhvani Abhijit Tanna 
Designation  Post graduate student  
Affiliation  AB Shetty Memorial Institute of Dental Sciences 
Address  Door number 15, 4th floor, Deaprtment of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Derlakatte, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  07738250181  
Fax    
Email  dhvanitanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srikala Bhandary 
Designation  Additional Professor 
Affiliation  AB Shetty Memorial Instittute of Dental Sciences 
Address  Door number 15, 4th floor, Deaprtment of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Derlakatte, Mangalore
Medical Sciences Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9535620371  
Fax    
Email  drsrikalabhandary@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Srikala Bhandary 
Designation  Additional Professor 
Affiliation  AB Shetty Memorial Instittute of Dental Sciences 
Address  Door number 15, 4th floor, Deaprtment of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Derlakatte, Mangalore
Medical Sciences Complex, Deralakatte, Mangaluru

KARNATAKA
575018
India 
Phone  9535620371  
Fax    
Email  drsrikalabhandary@nitte.edu.in  
 
Source of Monetary or Material Support  
self sponsored 
 
Primary Sponsor  
Name  Dr Dhvani Abhijit Tanna  
Address  Door number 15, 4th floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru 
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 Dhvani Tanna   AB Shetty Memorial Institute of Dental Sciences, Mangalore   Door number 15, 4th floor, Department of Pediatric and Preventive Dentistry, AB Shetty Memorial Institute of Dental Sciences, Medical Sciences Complex, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA 		 7738250181

dhvanitanna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, AB Shetty Memorial Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Children aged 7-11 years requiring invasive dental treatment  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Behaviour management techniques  Comparing 3 behaviour management techniques during and after administration of local anesthetic block  
Intervention  Progressive Muscle Relaxation, Autonomous Sensory Meridian Response, Conventional Behaviour management techniques like tell show do and communication   Comparing newer behaviour management techniques to conventional techniques frequency: one time before administration of local anesthesia for 15 minutes  
 
Inclusion Criteria  
Age From  7.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1. Children between the ages 7-11 years with a score of 26 and above who fall in the category of being anxious on the Faces version of Modified Child Dental Anxiety Scale (MCDASf).
2. Children who require invasive dental procedures under local anaesthetic block.
3. Children with parental consent.
 
 
ExclusionCriteria 
Details  1. Children with known allergy to local anaesthesia.
2. Children with specific medical illnesses.
3. Children with special health care needs.
4. Children/ parents unwilling to participate.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Dates of Birth or day of the Week 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in objective and subjective parameters of anxiety in children   during and after administration of local anesthetic block  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   23/09/2022 
Date of Study Completion (India) 31/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/12/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
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)  

‘Dental Fear and Anxiety’ is described as strong negative feelings associated with dental treatment among children and adolescents which can cause a delay in treatment or render it impossible. Children with high levels of dental anxiety have shown increased numbers of decayed, missing and filled tooth surfaces. Extraction and pulp therapy patients show the least cooperation, as both these procedures are invasive and involve administration of local anesthesia, loss of blood and child may experience pain or be forced to stay cooperative during treatment. Dental anxiety, if left unaddressed, can intensify in adulthood

Behavior management strategies are techniques employed by the dentist to alleviate fear and anxiety in the child and are flexible and individualized. They require a thorough understanding of cognitive, emotional and social development of the child to establish effective communication between child, dentist and the parent. Conventional behavior management techniques like establishing good communication, use of Tell-Show-Do and positive reinforcement have been effectively used in anxious patients.

Progressive Muscle Relaxation (PMR) is a relaxation technique in which a person first tenses and releases major muscle of the body in a systematic order, usually beginning at the distal body parts and progressing proximally. The main rationale for this is when the body is aware of the presence of the tension, it will respond by triggering the muscles to relax, where the rest of the other components of the relaxation response will naturally follow which tends to cause parasympathetic dominance.

Autonomous Sensory Meridian Response (ASMR) is a perceptual phenomenon characterized by pleasurable tingling sensations in the head and neck, as well as feelings of relaxation, that reliably arise while attending to a specific triggering stimulus (e.g., auditory, visual, tactile). These sensations are accompanied by a sense of calm and a positive effect.

Various conventional techniques have been used with great efficiency; nevertheless, the non-acceptance of some of them by the parents, certain ethical and legal conditions as well as changes in the current education and the advance in new technologies, emphasize the need for newer modalities. To the best of our knowledge, no studies have been conducted using PMR and ASMR behavior management techniques on dental anxiety in pediatric patients requiring invasive dental procedures under local anaesthetic block and their efficacy on alleviating dental anxiety. Hence, the need for this study.

 Aim:

To compare the effectiveness of Progressive Muscle Relaxation technique (PMR), Autonomous Sensory Meridian Response (ASMR) to conventional behaviour management techniques (Communication, Tell-Show-Do and Positive Reinforcement) on alleviating dental anxiety in children who require invasive dental procedures under local anaesthetic block.

Methodology:

A total of 78 children between the age group 7-11 years requiring local anesthesia for dental treatment, reporting to the OPD of the Department of Pediatric and Preventive Dentistry at AB Shetty Memorial Institute of Dental Sciences, Mangalore will be included in this study. They will be randomly divided into three groups:

·        STUDY GROUP I – 26 children who require invasive dental procedures under local anaesthetic block using Progressive Muscle Relaxation technique.

·        STUDY GROUP II- 26 children who require invasive dental procedures under local anaesthetic block using Autonomous Sensory Meridian Response.

       Â·        CONTROL GROUP- 26 children who require invasive dental procedures under local anaesthetic block using conventional behaviour management techniques (Communication, Tell-Show-Do and Positive Reinforcement). 



Dental anxiety levels in children will be pre-operatively measured using the faces version of Modified Child Dental Anxiety Scale. 7-11 year old children with a score of 26 and above will be included in the study. 

























Anxiety levels in children before and after the behaviour management technique will be measured by:

  • Physiological Parameters: Oxygen Saturation and Pulse Rate by the means of a pulse oximeter and Blood Pressure by an automated blood pressure machine.

  • Subjective Parameters: Visual Facial Anxiety Scale
  • These parameters will be compared before and after the behaviour management technique and during the administration of local anaesthetic block.

 
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