Dental AnxietyNCT06349200
Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients
A study testing 432 Hz music, Binaural beats and White noise in people with Dental Anxiety, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- 432 Hz music, Binaural beats and White noise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 2 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Dental Anxiety
- Being tested
- 432 Hz music, Binaural beats, White noise
- Keywords
- Preoperative Dental Anxiety, 432 Hz Music, Binaural Beats, White Noise, Audio Distraction, Root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
432 Hz musicBehavioural
Also called Natural frequency 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
Binaural beatsBehavioural
Also called Binaural tones
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
White noiseBehavioural
Also called White static
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: White noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes after the sound intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Oct 2023
- Primary completion30 Mar 2024
- Study completion2 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsa Zaki, Dow University of Health Sciences
- Investigators
- Dr. Hafsa Zaki, Principal investigator, DUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349200
- Sponsor's protocol ID
- 3197
- Status last verified
- May 2024
- First submitted
- 31 Mar 2024
- Last updated
- 14 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 36959385Menziletoglu 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.
PubMed 33247575Dabiri 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.
PubMed 35615269Di 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.
PubMed 27430941Calamassi 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.
PubMed 35545982Aravena 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.
PubMed 32401941Isik 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.
PubMed 28325532Zaki 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.
PubMed 40269359
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Binaural Beats and 432Hz Music for Reduction of Preoperative Anxiety in Root Canal Patients: an RCT Study
- ClinicalTrials.gov ID
- NCT06349200
- Acronym / sponsor ID
- 3197
- Conditions
- Dental Anxiety
- Keywords
- Preoperative Dental Anxiety, 432 Hz Music, Binaural Beats, White Noise, Audio Distraction, Root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 2 May 2024 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 432 Hz Music | Experimental | Behavioral: 432 Hz musicGroup A will listen to music tuned to 432 Hz (Summer by Stefano Crespan Shantam on Spotify) using wireless headphones for 10 minutes. |
| Binaural Beats | Experimental | Behavioral: Binaural beatsGroup 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. |
| Control | Active comparator | Behavioral: White noiseGroup C will be the active control group. The patients will listen to white noise for 10 minutes using wireless headphones. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 432 Hz musicAlso: Natural frequency musicMusic 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 | Behavioural | 432 Hz Music |
| Binaural beatsAlso: Binaural tonesBinaural 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 | Behavioural | Binaural Beats |
| White noiseAlso: White staticWhite 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. | Behavioural | Control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 36959385Karapicak 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.
- Background: PubMed 33247575Menziletoglu 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.
- Background: PubMed 35615269Dabiri 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.
- Background: PubMed 27430941Di 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.
- Background: PubMed 35545982Calamassi 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.
- Background: PubMed 32401941Aravena 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.
- Background: PubMed 28325532Isik 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.
- Derived from this study: PubMed 40269359Zaki 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Hafsa Zaki principal investigator
DUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 432 Hz music, Binaural beats and White noise in people with Dental Anxiety, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pre-operative Dental Anxiety score using Visual Analog Scale for Anxiety (time frame: 10 minutes after the sound intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06349200, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.