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CTRI Number  CTRI/2024/04/065138 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of relaxing soundwaves on dental anxiety. 
Scientific Title of Study   Effect of Alpha soundwave auditory stimulation on anxiety levels in patients undergoing endodontic treatment: A Randomised Controlled 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  Saumya Johri 
Designation  SENIOR RESIDENT 
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of dentistry, ground floor, c block, AIIMS Raipur, Taatibandh

Raipur
CHHATTISGARH
492099
India 
Phone  08840854587  
Fax    
Email  saumya.johry@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Saumya Johri 
Designation  SENIOR RESIDENT 
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of dentistry, ground floor, c block, AIIMS Raipur, Taatibandh

Raipur
CHHATTISGARH
492099
India 
Phone  08840854587  
Fax    
Email  saumya.johry@gmail.com  
 
Details of Contact Person
Public Query  
Name  Saumya Johri 
Designation  SENIOR RESIDENT 
Affiliation  All India Institute Of Medical Sciences, Raipur 
Address  Department of dentistry, ground floor, c block, AIIMS Raipur, Taatibandh

Raipur
CHHATTISGARH
492099
India 
Phone  08840854587  
Fax    
Email  saumya.johry@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of medical research 
 
Primary Sponsor  
Name  Indian Council of medical research 
Address  V Ramalingaswami Bhawan, P.O Box No 4911.Ansari nagar,New Delhi 110029 
Type of Sponsor  Contract research organization 
 
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 Ramesh bharti  King georges medical university and hospital.  Faculty clinic, Department of conservative dentistry and endodontics, Old dental building, First floor,Shahmina Shah Road, Chowk.
Lucknow
UTTAR PRADESH 		 9935724723

rameshbharti@kgmcindia.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University UP Institutional Ethics Commitee Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Auditory alpha stimulation  auditory stimulation for alpha waves will be done via playlist available on a software application available on mobile phones.(Brainwaves, iMobile Inc.in) for 15 minutes in the experimental group. 
Comparator Agent  No auditory stimulation  In the control group, the patients will be asked to wear the headphones for 15 minutes and no auditory stimulation will be given. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1- Patients undergoing endodontic treatment(Symptomatic irreversible pulpitis) for the first time(no previous history of dental treatment).
2- Patients with a modified dental anxiety scale(MDAS) score of 11 or higher (classified as dentally anxious patient) indicated for a single sitting root canal treatment.
 
 
ExclusionCriteria 
Details  1- Patients taking anti-anxiety, anti-depression, anti-psychotic, or any other neurological medications/therapy.
2- Patients on treatment for cardiac, renal, respiratory, auto-immune and infectious diseases (like HIV, hepatitis).
3- Uncooperative, pregnant, lactating, and specially-abled patients.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1-Systolic and Diastolic blood pressure(mmHg)
2-Heart rate(beats/min) 		 15 mins after the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   14/04/2024 
Date of Study Completion (India) 20/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
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 - NO
Brief Summary
Modification(s)  		 The current study will be a single-center, triple-blinded, placebo-controlled, two-arm, parallel design (allocation ratio 1:1) randomized controlled trial. Those patients who have a score of ≥ 11 will be randomly divided into two groups, the Control group (No auditory stimulation) and the Experimental group (Auditory alpha stimulation).Pre-operative diastolic-systolic blood pressure and heart rate will be recorded for all patients by a third person, unrelated to the study by standardized apparatus(Omron HEM 7120, Omron Healthcare Manufacturing, Thu-dau-mot, Vietnam)  Patient will be blinded to the study. Based on the allocated group the subjects will be asked to wear noise cancellation headphones(Sony WH-CH510/BZ,Sony, Tokyo, Japan) by a nurse who isn’t part of the study where auditory stimulation for alpha waves will be done via playlist available on a software application available on mobile phones. (Brainwaves, iMobLife Information Technology CoLtd) for 15 minutes in the experimental group. In the control group, the patients will be asked to wear the headphones and no auditory stimulation will be given. Hemodynamic findings(blood pressure and heart rate) will be again recorded after auditory stimulation at this point. A single trained operator who is also blinded to the intervention given will be performing single sitting root canal treatment to standardize the bias associated with the skill of the operator, After the treatment is completed, hemodynamic findings will be recorded and assessed by a blinded outcome assessor. The parameters used to analyze anxiety are blood pressure, heart rate, and a modified dental anxiety scale. Kolmogorov-Smirnov test will be applied to check whether the data fits the normal distribution, Continuous variables conforming to a normal distribution will be expressed as mean ± standard deviation, and continuous variables not conforming to normal distribution will be expressed as median and inter-quartile range. Counting data will be expressed as numbers and percentages. The independent-sample t-test/Mann-Whitney test will be used for inter-group analysis of quantitative data while paired sample t-test/Wilcoxon signed rank test will be used for intragroup analysis. The chi-square ( χ2) test will used to compare the proportion data between the groups and the intubation accuracy of the two groups. Other appropriate statistical tests will be used. In all of the statistical analyses, P < 0.05 will be considered to be statistically significant..

 

 
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