| CTRI Number |
CTRI/2025/11/097916 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
The effect of various types of music on blood pressure and heart rate as evaluated during root canal therapy |
|
Scientific Title of Study
|
EVALUATION OF BINAURAL BEATS, ISOCHRONIC TONES AND WHITE NOISE IN REDUCTION OF DENTAL ANXIETY AND PHYSIOLOGICAL INDICES IN PATIENT REQUIRING ROOT CANAL THERAPY. A RANDOMIZED 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 |
Dr Ramchandra Kabir |
| Designation |
Professor and Head of the Department |
| Affiliation |
MIDSR DENTAL COLLEGE LATUR |
| Address |
Room no. 9 First floor Department of Conservative Dentistry and Endodontics MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH LATUR 413512 LATUR MAHARASHTRA
Latur
MAHARASHTRA
413512
India |
| Phone |
9920297557 |
| Fax |
|
| Email |
drramchandrakabir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shradha Ram Kombade |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
MIDSR DENTAL COLLEGE LATUR |
| Address |
Room no. 9 First floor Department of Conservative Dentistry and Endodontics MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH LATUR 413512 LATUR MAHARASHTRA
Latur
MAHARASHTRA
413512
India |
| Phone |
09011033338 |
| Fax |
|
| Email |
shradhakombade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramchandra Kabir |
| Designation |
Professor and Head of the Department |
| Affiliation |
MIDSR DENTAL COLLEGE LATUR |
| Address |
Room no. 9 First floor Department of Conservative Dentistry and Endodontics MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH LATUR 413512 LATUR MAHARASHTRA
Latur
MAHARASHTRA
413512
India |
| Phone |
9920297557 |
| Fax |
|
| Email |
drramchandrakabir@gmail.com |
|
|
Source of Monetary or Material Support
|
| MIDSR DENTAL COLLEGE LATUR 413512 India |
|
|
Primary Sponsor
|
| Name |
DrShradha Ram Kombade |
| Address |
Room no.9 First Floor Department of Conservative Dentistry and Endodontics |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramchandra Kabir |
MAHARASHTRA INSTITUTE OF DENTAL SCIENCESAND RESEARCH DENTAL COLLEGE LATUR |
Room no. 9 First floor Department of Conservative Dentistry and Endodontics MAHARASHTRA INSTITUTE OF DENTAL SCIENCES AND RESEARCH LATUR 413512 LATUR MAHARASHTRA
Latur
MAHARASHTRA |
09920297557
drramchandrakabir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMITTEE MIDSRDC LATUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Binaural music |
The subject undergoing root canal therapy will receive the music therapy for 10 min in the form of regular rhythmic 344 right ear and340 Hz to left year beats |
| Intervention |
Isochronic music for 10 min |
The subject undergoing root canal therapy will receive the music therapy for 10 min in the form of regular rhythmic 8 Hz beats |
| Comparator Agent |
No music |
patient will not receive any music but the patient will be wearing active noise cancellation head phone |
| Intervention |
White noise music |
The subject undergoing root canal therapy will receive the music therapy for 10 min in the form of regular rhythmic 432 Hz music |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy Patients (ASA I or ASA II).
Subjects diagnosed with irreversible pulpitis requiring root canal therapy.
Subjects requiring root canal therapy with any tooth apart from third molars will be considered.
Irreversible pulpitis or necrosis of pulp secondary to dental caries.
Subjects giving written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Children below the age of 18 years above 60 yr.
2.Pt on antihistamines, antidepressants, anticholinergics.
3.Medically compromised patient ex. Epileptic , Diabetic, Hpertensive .
4.Patients who have not signed the consent form.
5.Patient not willing to participant in study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in systolic blood pressure |
Systolic blood pressure measured before starting the root canal treatment and music therapy, and after starting both at 5 min and 10 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in diastolic blood pressure |
Diastolic blood pressure measured before starting the root canal treatment and music therapy, and after starting both at 5 min and 10 min
|
| Change in Heart Rate |
Heart Ratemeasured before starting the root canal treatment and music therapy, and after starting both at 5 min and 10 min
|
| Change in Anxiety level |
Anxiety level measured before starting the root canal treatment and music therapy, and after starting both at 5 min and 10 min using corahs dental anxiety scale
|
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
05/01/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drramchandrakabir@gmail.com].
- For how long will this data be available start date provided 01-02-2026 and end date provided 29-02-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Title Evaluation Of Binaural
Beats, Isochronic Tones, White Noise Music In Reduction Of Dental Anxiety and
physiological indices in patients requiring root canal therapy: A Randomized Controlled
Trial. Among various dental procedures, endodontic treatment is often
regarded as one of the most painful and anxiety-provoking experiences by
patients. Studies have shown that a significant portion of the population
reports high levels of fear and anxiety related to root canal therapy
Dental procedures are generally associated with
discomfort and pain, and many individuals experience apprehension both before
and after treatment. Dental anxiety remains one of the major challenges in
dental practice, often interfering with effective treatment delivery.
Epidemiological studies suggest that approximately 20–30 percentage of individuals
experience fear or anxiety prior to dental care.
Severe anxiety can heighten the perception of pain during and after
dental procedures, increase the risk of psychological distress or syncope,
reduce the frequency of dental visits, and negatively affect the patient’s
overall quality of life.
One of the effective non-pharmacological
methods for alleviating dental anxiety is music-induced relaxation. Music
therapy serves as a supportive approach that can help manage various physical,
emotional, and psychological conditions such as pain, anxiety, depression, and
communication difficulties.
Given the limited number of studies exploring binaural beat technology
in dental settings and its promising clinical potential, the present research aims to evaluate the
effect of binaural beats on patients’ anxiety levels during and after dental
procedures.
Binaural beats are auditory illusions perceived
when two tones of slightly different frequencies are presented separately to
each ear. The brain interprets these as a single sound with a fluctuating
amplitude at a frequency equal to the difference between the two tones.
In contrast, isochronic tones are composed of
single, regularly repeating beats of a specific tone. The perceived frequency
corresponds to the number of amplitude peaks per second, creating rhythmic
auditory stimulation.
Another form of relaxation-based intervention
is music therapy using 432 Hz frequency, which is considered by many musicians
to be more in harmony with natural human resonance. Music with slow tempo and
soothing melody induces emotional calmness and physical relaxation in
listeners. This “neutral” type of music minimizes emotional triggers that may
otherwise provoke physiological stress responses. According to Steelman, music
therapy can lower blood pressure, stabilize heart rhythm irregularities, and promote
relaxation during procedures performed under local anesthesia. This single-center, parallel-group, double
blind, randomized control trial
was conducted on 96 adult patients requiring root canal therapy.
Corah Dental Anxiety Scale was used to assess the baseline anxiety
levels of patients along with baseline Systolic (SBP) & Diastolic (DBP)
blood pressure along with heart rate (HR). Patients were then divided into 4
groups depending on the sound they will experience, Group 1: Binaural Beats,
Group 2: Isochronic tones, Group 3: White noise and Group 4: No Sound. Anxiety levels and SBP, DBP and HR were again
measured at two different intervals, after exposure to the sounds.
Statistical
analysis was carried out using One way Anova and Kruskal Wallis test.
|