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CTRI Number  CTRI/2026/03/105848 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 01/08/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of relaxing instrumental music with nature sounds on dental anxiety in patients undergoing root canal treatment 
Scientific Title of Study   Effect of Music as a Non-Pharmacological Intervention on Dental Anxiety and Physiological Parameters During Root Canal Treatment: A Prospective Randomised Controlled Clinical 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  Vivek Taduri 
Designation  Associate Professor 
Affiliation  Mamata Institute of Dental Sciences 
Address  Department of Conservative Dentistry and Endodontics Room No. 6 Mamata Institute of Dental Sciences Bollaram Industrial Area

Hyderabad
TELANGANA
500118
India 
Phone  8688090903  
Fax    
Email  vivektaduri@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  G Deepthi Sarvani 
Designation  Professor and Head of the Department 
Affiliation  Mamata Institute of Dental Sciences 
Address  Department of Conservative Dentistry and Endodontics Room No. 6 Mamata Institute of Dental Sciences

Hyderabad
TELANGANA
500118
India 
Phone  9000545364  
Fax    
Email  deepthi.grandhala@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sachin Muthyala 
Designation  Undergraduate Student 
Affiliation  Mamata Institute of Dental Sciences 
Address  Department of Conservative Dentistry and Endodontics Room No. 6 Mamata Institute of Dental Sciences

Hyderabad
TELANGANA
500118
India 
Phone  8008947608  
Fax    
Email  muthyalasachin1@gmail.com  
 
Source of Monetary or Material Support  
Mamata Institute of Dental Sciences, Bollaram Industrial Area, Hyderabad, Telangana 500118 
 
Primary Sponsor  
Name  Department of Conservative Dentistry and Endodontics 
Address  Mamata Institute of Dental Sciences, Bollaram Industrial Area, Hyderabad, Telangana 500118 
Type of Sponsor  Private medical college 
 
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 Vivek Taduri  Mamata Institute of Dental Sciences  Room no-6, Second Floor, Department of Conservative Dentistry and Endodontics.
Hyderabad
TELANGANA 		 8688090903

vivektaduri@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Mamata Academy Of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F402||Specific (isolated) phobias, (2) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Participants allocated to the control group will undergo standard root canal treatment under local anesthesia without exposure to any music or relaxing sounds. All clinical procedures, treatment protocols, operator, and clinical environment will be maintained identical to those in the intervention group, except for the absence of the audio intervention. The root canal treatment procedure will be carried out for approximately 45–60 minutes, which represents the usual duration of a single-visit endodontic treatment. 
Intervention  Music Group   Participants randomized to the intervention group will be exposed to standardized relaxing instrumental music combined with natural ambient sounds delivered through wireless earphones during the root canal treatment procedure. The audio track will consist of slow-tempo instrumental music integrated with calming nature sounds (such as flowing water, rainfall, and forest sounds) designed to promote relaxation. The audio will be initiated 5 minutes prior to the commencement of the root canal treatment and will continue throughout the entire procedure for approximately 45–60 minutes in total. The sound volume will be maintained at a comfortable and standardized listening level for all participants. All participants in this group will receive standard endodontic treatment under local anesthesia, and the relaxing sound intervention will be used as a non-pharmacological adjunctive method to reduce dental anxiety. 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Adult patients aged 35–50 years requiring single-visit root canal treatment in permanent teeth.
2. Patients classified as American Society of Anesthesiologists (ASA) Physical Status I or II.
3. Patients able to understand the study protocol and provide written informed consent.
4. Patients willing to comply with the study procedures. 
 
ExclusionCriteria 
Details  1. Patients with hearing impairment or use of hearing aids that may interfere with the audio intervention.
2. Patients currently taking anxiolytic, sedative, antidepressant, or beta-blocker medications that may influence anxiety levels or physiological parameters.
3. Patients with diagnosed psychiatric disorders or cognitive impairment affecting anxiety assessment.
4. Patients with uncontrolled systemic diseases (e.g., uncontrolled hypertension or unstable cardiovascular disease).
5. Patients requiring retreatment, multi-visit endodontic treatment, or surgical endodontic procedures.
6. Patients unwilling to participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of the study is change in pulse rate (beats per minute) measured using a pulse oximeter. To compare pulse rate during root canal treatment between patients exposed to relaxing instrumental music with nature-based ambient sounds and those receiving standard root canal treatment without music.  T0 (Baseline): Pulse rate recorded prior to administration of local anesthesia and initiation of the root canal procedure.

T1 (Intra-operative): Pulse rate recorded 5 minutes after initiation of canal instrumentation during the root canal procedure.

T2 (Post-operative): Pulse rate recorded immediately after completion of the root canal treatment procedure.

These measurements will be used to compare changes in pulse rate between the music group and the control group. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess baseline dental anxiety levels of participants using the Modified Dental Anxiety Scale (MDAS) prior to the procedure.  T0 (Baseline): Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS) prior to administration of local anesthesia & initiation of the root canal procedure. 
To compare oxygen saturation (SpO2) levels between the music group & the control group during root canal treatment.  T0 (Baseline): Prior to initiation of the root canal procedure & before administration of local anesthesia.
T1 (Intra-operative): Five minutes after initiation of canal instrumentation during the root canal procedure.
T2 (Post-operative): Immediately after completion of the root canal treatment procedure. 
To evaluate the overall treatment experience & perceived comfort of patients using a five-point Likert scale following completion of the root canal treatment.  T2 (Post-operative): Patient postoperative experience assessed immediately after completion of the endodontic treatment using a 5-point Likert scale questionnaire. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2026 
Date of Study Completion (India) 05/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   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   This prospective, randomized, controlled clinical trial aims to evaluate the effect of music on dental anxiety and physiological parameters during root canal treatment. The study hypothesizes that music significantly reduces pulse rates and anxiety scores and improves comfort during the procedure. A total of 100 adults aged 35 to 50 years requiring single-visit root canal treatment, with ASA I or II and willingness to provide written informed consent. Exclusion criteria include hearing impairment, known psychiatric illness, unstable cardiovascular disease, and current use of sedatives and anxiolytics. Participants will be randomly assigned to either a music group, which will listen to relaxing instrumental music with ambient nature sounds through wireless earphones initiated 5 minutes prior to the treatment and continuing throughout, along with standard root canal treatment, or to a control group, which will receive the standard root canal treatment without music exposure. Pulse rate and oxygen saturation will be recorded at three time points: before treatment, during instrumentation, and after treatment. Anxiety scores will be measured before the treatment using a Modified Dental Anxiety Scale (MDAS), and postoperative experience questionnaire will be measured after the treatment using a five-point Likert scale. The primary outcome is the change in pulse rate, and secondary outcomes include anxiety scores, oxygen saturation, and postoperative experience levels. The study expects music to reduce dental anxiety and physiological parameters and improve patient comfort during root canal treatment. 
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