Clinical trial NCT06349200: Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients
Official title: Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients: an RCT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: Preoperative Dental Anxiety
432 Hz Music
Binaural Beats
White Noise
Audio Distraction
Root canal treatment
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety
timeFrame: 10 minutes after the sound intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
affiliation: DUHS
name: Dr. Hafsa Zaki
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.