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

NCT06349200 | Completed

• 1 other identifier: 3197
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Anxiety

Keywords

Preoperative Dental Anxiety; 432 Hz Music; Binaural Beats; White Noise; Audio Distraction; Root canal treatment

Outcome Measures

Primary Outcomes (1)

• Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety

  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

Study Arms (3)

432 Hz Music

EXPERIMENTAL

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

Binaural Beats

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

Group C will be the active control group. The patients will listen to white noise for 10 minutes using wireless headphones.

Behavioral: White noise

Interventions

432 Hz music BEHAVIORAL

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

Also known as: Natural frequency music

432 Hz Music

Binaural beats BEHAVIORAL

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

Also known as: Binaural tones

Binaural Beats

White noise BEHAVIORAL

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.

Also known as: White static

Control

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

Location

Related Publications (8)

• Karapicak E, Dulger K, Sahin E, Alver A. Investigation of the effect of music listened to by patients with moderate dental anxiety during restoration of posterior occlusal dental caries. Clin Oral Investig. 2023 Jul;27(7):3521-3530. doi: 10.1007/s00784-023-04966-8. Epub 2023 Mar 24.

  PMID: 36959385 BACKGROUND

• Menziletoglu D, Guler AY, Cayir T, Isik BK. Binaural beats or 432 Hz music? which method is more effective for reducing preoperative dental anxiety? Med Oral Patol Oral Cir Bucal. 2021 Jan 1;26(1):e97-e101. doi: 10.4317/medoral.24051.

  PMID: 33247575 BACKGROUND

• Dabiri R, Monazzam Esmaielpour MR, Salmani Nodoushan M, Khaneshenas F, Zakerian SA. The effect of auditory stimulation using delta binaural beat for a better sleep and post-sleep mood: A pilot study. Digit Health. 2022 May 20;8:20552076221102243. doi: 10.1177/20552076221102243. eCollection 2022 Jan-Dec.

  PMID: 35615269 BACKGROUND

• Di Nasso L, Nizzardo A, Pace R, Pierleoni F, Pagavino G, Giuliani V. Influences of 432 Hz Music on the Perception of Anxiety during Endodontic Treatment: A Randomized Controlled Clinical Trial. J Endod. 2016 Sep;42(9):1338-43. doi: 10.1016/j.joen.2016.05.015. Epub 2016 Jul 16.

  PMID: 27430941 BACKGROUND

• Calamassi D, Li Vigni ML, Fumagalli C, Gheri F, Pomponi GP, Bambi S. The Listening to music tuned to 440 Hz versus 432 Hz to reduce anxiety and stress in emergency nurses during the COVID-19 pandemic: a double-blind, randomized controlled pilot study. Acta Biomed. 2022 May 12;93(S2):e2022149. doi: 10.23750/abm.v93iS2.12915.

  PMID: 35545982 BACKGROUND

• Aravena PC, Almonacid C, Mancilla MI. Effect of music at 432 Hz and 440 Hz on dental anxiety and salivary cortisol levels in patients undergoing tooth extraction: a randomized clinical trial. J Appl Oral Sci. 2020;28:e20190601. doi: 10.1590/1678-7757-2019-0601. Epub 2020 May 11.

  PMID: 32401941 BACKGROUND

• Isik BK, Esen A, Buyukerkmen B, Kilinc A, Menziletoglu D. Effectiveness of binaural beats in reducing preoperative dental anxiety. Br J Oral Maxillofac Surg. 2017 Jul;55(6):571-574. doi: 10.1016/j.bjoms.2017.02.014. Epub 2017 Mar 18.

  PMID: 28325532 BACKGROUND

• Zaki H, Ahmed S, Rehman Qazi FU, Fatima N, Ali YS. Comparing binaural beats and 432 Hz music for reduction of preoperative anxiety in root canal patients: a randomized controlled trial. J Pak Med Assoc. 2025 Apr;75(4):540-544. doi: 10.47391/JPMA.21023.

  PMID: 40269359 DERIVED

Study Officials

• Dr. Hafsa Zaki

  DUHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 5, 2024
• Study Start: October 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: May 2, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)