Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients

May 12, 2024 updated by: Hafsa Zaki, Dow University of Health Sciences

Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients: an RCT Study

Many patients suffer from dental anxiety and don't go to dentists for regular checkups. This can lead to the initiation and progression of dental caries, which, if not controlled at the right time, can lead to the loss of the tooth itself. Many forms of distraction have been used to overcome this; music is also one of them. The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing root canal treatment in a dental teaching hospital. The null hypothesis is that both binaural beats and 432 Hz-frequency music are not effective in reducing preoperative dental anxiety among patients undergoing routine endodontic therapy in a dental teaching hospital. A total of three groups will be a part of this study, with a total sample size of 99 participants (33 participants in each group). Group A will listen to 432 Hz music for 10 minutes before the procedure, Group B will listen to binaural beats for 10 minutes before the procedure; and Group C (active control group) will listen to white noise for 10 minutes before the procedure. The Visual Analog Scale for Anxiety will be used to assess the anxiety levels before local anesthesia administration, after local anesthesia administration, and 10 minutes after listening to sounds. Then root canal treatment will be completed as a routine procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

i. Background Patients undergoing routine endodontic treatment often encounter severe preoperative and intraoperative anxiety that can increase the perception of pain intensity and decrease patient's cooperation with the dentist. Many audio distraction techniques have been used as a non-pharmacological means of anxiety reduction in dentistry for the past few years, and they have shown great results.

ii. Objective The main objective of this study is to compare the effectiveness of binaural beats and 432 Hz music in reducing preoperative dental unease and anxiety among adult patients undergoing routine, nonsurgical endodontic treatment in dental teaching hospital.

iii. Methodology In this randomized controlled clinical trial, a total of 99 adult patients will be recruited and will be randomly divided into three groups based on the anxiety reduction method. The first group (n = 33) will listen to music tuned to 432 Hz using wireless headphones. The second group (n = 33) will listen to binaural beats using wireless headphones, and the third group (n = 33), the control group, will listen to white noise using wireless headphones. All the patients will be informed about the procedure, and anxiety will be measured using the Visual Analogue Scale before the administration of local anesthesia. After the administration of local anesthesia, a second measurement of anxiety level will be recorded. After that, the group A will be asked to listen to 432 Hz audios using wireless headphones, group B will be requested to listen to binaural sounds using wireless headphones, and the group C (active control group) will listen to white noise using wireless headphones. After 10 minutes, anxiety will be measured again using the Visual Analog Scale. The root canal treatment will be completed in the usual way.

vi: Sequence Generation: Participants will be randomized using a lottery method to either one of the interventional groups or the control group. This method will ensure that each participant has an equal chance of being assigned to either group. 99 small pieces of paper will be made; 33 of them will have the letter 'A' written on them, 33 of them will have the letter 'B' written on them, and the remaining 33 will have the letter 'C' written on them, denoting their respective groups. All of these chits will be folded four times and placed in a hat. The participants will be asked to draw one piece of paper from the hat to be assigned to one group.

vii: Blinding: The participants and outcome assessors will be blinded in this research (double blinded). The participants will not know about their group assignment or the intervention they will receive and the outcome assessors will not know about what intervention has been given to the patients.

viii: Allocation Concealment: The lottery draw will be conducted by an independent person not involved in the study to ensure allocation concealment.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Both male and female patients.
  • Patients between the age group of 18-45 years.
  • Patients who are appointed for endodontic treatment.
  • Maxillary or mandibular teeth with a history of pulp necrosis or no history of preoperative pain.

Exclusion Criteria:

  • Patients who will require emergency dental treatment.
  • Patients who will be taking antidepressants or medications for any kind of disease.
  • Patients who will have any kind of hearing impairment.
  • Patients who will be suffering from any kind of chronic, systemic, endocrine, or mental disease.
  • Pregnant or lactating women and pediatric patients.
  • Smokers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 432 Hz Music
Group A will listen to music tuned to 432 Hz (Summer by Stefano Crespan Shantam on Spotify) using wireless headphones for 10 minutes.
Behavioral: 432 Hz music
Music tuned to the 432 Hz frequency, as compared with other frequencies, has the advantage of providing utter calm, pleasure, and peace to its listeners. It has proven to be effective for reducing stress and improving sleep quality
Other Names:
  • Natural frequency music
Experimental: Binaural Beats
Group B will listen to binaural beats (220 Hz for the right ear and 210 Hz for the left ear) using wireless headphones for 10 minutes. The frequencies will be generated by the mobile application BrainWaves Binaural Beats, MynioTech Apps, Chanpeco, Santa Catarina, Brazil.
Behavioral: Binaural beats
Binaural beats are defined as the sound that is born when two sounds of constant intensity but different frequencies are presented to both ears separately. The resultant sound perceived in the brain has a single tone and a frequency equivalent to the difference between the frequencies of the carrier sounds
Other Names:
  • Binaural tones
Active Comparator: Control
Group C will be the active control group. The patients will listen to white noise for 10 minutes using wireless headphones.
Behavioral: White noise
White noise is a type of random sound characterized by equal intensity across all frequencies within the audible range, resulting in a steady, uniform sound similar to the static from a television or radio tuned to an unused frequency.
Other Names:
  • White static

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety
Time Frame: 10 minutes after the sound intervention
The visual analog scale for anxiety is a 100-mm horizontal line portrayed on paper, with the left side of the line depicting "no anxiety" and the right side of the line depicting "worst anxiety imaginable," with written instructions of marking a point on the line matching the anxiety level of the patients. The closer the mark will be from the left point of no pain, the more successful the intervention will be.
10 minutes after the sound intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Dr. Hafsa Zaki, DUHS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

March 30, 2024

Study Completion (Actual)

May 2, 2024

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 5, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 12, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is some information that can be sensitive to some patients. Sharing this data can compromise their confidentiality and cause a breach of their privacy. Anonymous data can be shared upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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