Dental PainNCT07543042
Evaluation of the Sedative Effect of Contextualized Music Listening on Patient Pain and Anxiety in a Dental Care Setting
A study testing Baseline Assessment (T0) and Music Listening Condition (Intervention Phase) in people with Dental Pain and Dental Anxiety, run by Rawane El Dimachki at 1 site in Lebanon.
Trial summary
The goal of this clinical study is to determine whether listening to culturally and personally contextualized music can reduce pain and anxiety in adults undergoing dental procedures. It will also examine how this intervention affects physiological responses related to stress. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dental Pain, Dental Anxiety
- What is being tested?
- Baseline Assessment (T0) and Music Listening Condition (Intervention Phase)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Oct 2025to 23 Dec 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients aged 18 to 60 years.
- Visiting the dental clinic for treatment of dental caries.
- Able to provide written informed consent.
Who cannot join
- Patients who do not provide written informed consent.
- Children (under 18 years of age).
- Patients with known mental or physical disorders.
- Pregnant women.
- Patients currently taking analgesics, anxiolytics, or antidepressants.
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
Private Dental Clinic of Dr. Mhammad El Dimachki
Baabda, Mount Lebanon
About this study
Official title: Musical Grammatological and Neurocognitive Parameterization of Analgesic and Anxiolytic Effects of Culturally and Personally Contextualized Music Listening During Painful Dental Procedures
The goal of this clinical study is to determine whether listening to culturally and personally contextualized music can reduce pain and anxiety in adults undergoing dental procedures. It will also examine how this intervention affects physiological responses related to stress.
The main questions it aims to answer are:
Read more
- Does listening to a preselected, patient-chosen musical sequence reduce perceived pain during a dental procedure?
- Does the music modulate physiological stress responses, such as heart rate and blood pressure?
- Do the analgesic and anxiolytic effects vary depending on the patient's cultural musical preferences (e.g., Mashriq vs. Western music)? How do patients perceive the effectiveness of the music, and how does this relate to physiological and self-reported measures?
Researchers will compare periods with and without music during the same dental procedure to evaluate the effect of the musical intervention.
Participants will:
- Choose a musical sequence from a predefined selection based on relaxing musical characteristics
- Undergo a dental treatment involving drilling for caries
- Experience alternating phases with and without music during the procedure
- Have their heart rate, blood pressure, and pain levels measured at different stages
- Complete questionnaires assessing anxiety before the procedure and their experience after the treatment
The study includes 30 adult participants and is conducted in a private dental clinic.
- Conditions
- Dental Pain, Dental Anxiety
- Being tested
- Baseline Assessment (T0), Control Condition - Silence (Pre-Music Phase), Music Listening Condition (Intervention Phase), Control Condition - Silence (Post-Music Phase)
- Keywords
- Music therapy, Dental pain, Dental anxiety, analgesia, non-pharmacological intervention, heart rate, blood pressure, stress response
- Medical subject headings
- Toothache, Agnosia, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Assessment (T0)Behavioural
Measurement of baseline physiological parameters (heart rate, systolic and diastolic blood pressure) prior to the dental procedure, without any auditory stimulation or dental drilling.
Control Condition - Silence (Pre-Music Phase)Behavioural
Participants undergo dental drilling for 30 seconds without music. Physiological parameters (heart rate, blood pressure) and perceived pain intensity are recorded to establish control measures prior to the music intervention.
Music Listening Condition (Intervention Phase)Behavioural
Participants listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist starting 2 minutes before and continuing during a 30-second dental drilling period. Physiological parameters (heart rate and blood pressure) and perceived pain intensity are recorded to assess the effects of the music intervention on pain and stress responses.
Control Condition - Silence (Post-Music Phase)Behavioural
Participants undergo a second 30-second dental drilling period without music following the intervention phase. Physiological parameters and perceived pain intensity are recorded to evaluate post-intervention effects and return to baseline conditions.
| Study group | Role | What they receive |
|---|---|---|
| Music Listening During Dental Procedure (Within-Subject Design) | Experimental | All participants are exposed to both control (no music) and intervention (music listening) conditions within the same dental procedure. After baseline measurements, participants undergo a standardized dental drilling sequence divided into phases: a control phase without music, an intervention phase during which they listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist, and a post-intervention control phase without music. Receives: Behavioral: Baseline Assessment (T0); Behavioral: Control Condition - Silence (Pre-Music Phase); Behavioral: Music Listening Condition (Intervention Phase); Behavioral: Control Condition - Silence (Post-Music Phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Pain Intensity
Participants report their pain level during each phase of the dental drilling procedure using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: At T0 (before the procedure), at T1 (30seconds after initiation of drilling, pre-music), at T2 (150seconds after initiation of the procedure,during music), at T3 (330seconds after initiation of the procedure,post-music) within a single treatment session.
Secondary outcomes (3)
Heart Rate
Participants' heart rate is continuously monitored using a pulse sensor throughout the procedure to evaluate autonomic nervous system responses.
Measured: Baseline (before the procedure), T1 (30 seconds after initiation of drilling, pre-music), T2 (150 seconds after initiation of the procedure, during music), T3 (330 seconds after initiation of the procedure, after music) within a single treatment session.
Blood Pressure (Systolic and Diastolic)
Systolic and diastolic blood pressure are measured as indicators of physiological stress during each phase of the dental procedure.
Measured: Baseline (before the procedure), T1 (30 seconds after initiation of drilling, pre-music), T2 (150 seconds after initiation of the procedure, during music), T3 (330 seconds after initiation of the procedure, after music) within a single treatment session.
Post-Treatment Perception of Music Effectiveness
After the procedure, participants complete a short questionnaire, a 6-item scale used to evaluate the subjective perception of music's effectiveness in reducing pain and anxiety, as well as overall satisfaction. Each item is scored on a Likert scale ranging from 1 (Not at all) to 7 (Completely).
The total score is calculated by summing the responses to all 6 items. The minimum possible total score is 6 and the maximum possible total score is 42. Higher scores indicate a better outcome (greater perceived effectiveness of the music, higher distraction, and higher patient satisfaction).
Measured: Measured immediately after the dental procedure (post-treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dental PainStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawane El Dimachki
- Sponsor type
- University, hospital or other
- Collaborators
- Sorbonne University
- Responsible party
- Sponsor-investigator, Rawane El Dimachki, Antonine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543042
- Sponsor's protocol ID
- 1606-2025
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666.
PubMed 24552785Singh D, Samadi F, Jaiswal J, Tripathi AM. Stress Reduction through Audio Distraction in Anxious Pediatric Dental Patients: An Adjunctive Clinical Study. Int J Clin Pediatr Dent. 2014 Sep-Dec;7(3):149-52. doi: 10.5005/jp-journals-10005-1254. Epub 2015 Feb 9.
PubMed 25709291Mejia-Rubalcava C, Alanis-Tavira J, Mendieta-Zeron H, Sanchez-Perez L. Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complement Ther Clin Pract. 2015 Nov;21(4):282-6. doi: 10.1016/j.ctcp.2015.10.005. Epub 2015 Oct 27.
PubMed 26573456Moola S, Pearson A, Hagger C. Effectiveness of music interventions on dental anxiety in paediatric and adult patients: a systematic review. JBI Libr Syst Rev. 2011;9(18):588-630. doi: 10.11124/01938924-201109180-00001.
PubMed 27819961Lai HL, Hwang MJ, Chen CJ, Chang KF, Peng TC, Chang FM. Randomised controlled trial of music on state anxiety and physiological indices in patients undergoing root canal treatment. J Clin Nurs. 2008 Oct;17(19):2654-60. doi: 10.1111/j.1365-2702.2008.02350.x.
PubMed 18808630Lahmann C, Schoen R, Henningsen P, Ronel J, Muehlbacher M, Loew T, Tritt K, Nickel M, Doering S. Brief relaxation versus music distraction in the treatment of dental anxiety: a randomized controlled clinical trial. J Am Dent Assoc. 2008 Mar;139(3):317-24. doi: 10.14219/jada.archive.2008.0161.
PubMed 18310736Gabai M. [Sound therapy and sophrology]. Inf Dent. 1969 Jun 12;51(24):2443-55. No abstract available. French.
PubMed 5254211
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Grammatological and Neurocognitive Parameterization of Analgesic and Anxiolytic Effects of Culturally and Personally Contextualized Music Listening During Painful Dental Procedures
- ClinicalTrials.gov ID
- NCT07543042
- Acronym / sponsor ID
- 1606-2025
- Conditions
- Dental Pain, Dental Anxiety
- Keywords
- Music therapy, Dental pain, Dental anxiety, analgesia, non-pharmacological intervention, heart rate, blood pressure, stress response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rawane El DimachkiUniversity, hospital or other
- Collaborators
- Sorbonne University
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 21 Apr 2026 (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.
The goal of this clinical study is to determine whether listening to culturally and personally contextualized music can reduce pain and anxiety in adults undergoing dental procedures. It will also examine how this intervention affects physiological responses related to stress.
The main questions it aims to answer are:
- Does listening to a preselected, patient-chosen musical sequence reduce perceived pain during a dental procedure?
- Does the music modulate physiological stress responses, such as heart rate and blood pressure?
- Do the analgesic and anxiolytic effects vary depending on the patient's cultural musical preferences (e.g., Mashriq vs. Western music)? How do patients perceive the effectiveness of the music, and how does this relate to physiological and self-reported measures?
Researchers will compare periods with and without music during the same dental procedure to evaluate the effect of the musical intervention.
Participants will:
- Choose a musical sequence from a predefined selection based on relaxing musical characteristics
- Undergo a dental treatment involving drilling for caries
- Experience alternating phases with and without music during the procedure
- Have their heart rate, blood pressure, and pain levels measured at different stages
- Complete questionnaires assessing anxiety before the procedure and their experience after the treatment
The study includes 30 adult participants and is conducted in a private dental clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music Listening During Dental Procedure (Within-Subject Design) | Experimental | Behavioral: Baseline Assessment (T0), Behavioral: Control Condition - Silence (Pre-Music Phase), Behavioral: Music Listening Condition (Intervention Phase), Behavioral: Control Condition - Silence (Post-Music Phase)All participants are exposed to both control (no music) and intervention (music listening) conditions within the same dental procedure. After baseline measurements, participants undergo a standardized dental drilling sequence divided into phases: a control phase without music, an intervention phase during which they listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist, and a post-intervention control phase without music. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 to 60 years.
- Visiting the dental clinic for treatment of dental caries.
- Able to provide written informed consent.
Key exclusion criteria (5 listed)
- Patients who do not provide written informed consent.
- Children (under 18 years of age).
- Patients with known mental or physical disorders.
- Pregnant women.
- Patients currently taking analgesics, anxiolytics, or antidepressants.
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 |
|---|---|---|
| Baseline Assessment (T0)Measurement of baseline physiological parameters (heart rate, systolic and diastolic blood pressure) prior to the dental procedure, without any auditory stimulation or dental drilling. | Behavioural | Music Listening During Dental Procedure (Within-Subject Design) |
| Control Condition - Silence (Pre-Music Phase)Participants undergo dental drilling for 30 seconds without music. Physiological parameters (heart rate, blood pressure) and perceived pain intensity are recorded to establish control measures prior to the music intervention. | Behavioural | Music Listening During Dental Procedure (Within-Subject Design) |
| Music Listening Condition (Intervention Phase)Participants listen to a self-selected musical sequence from a predefined, culturally and personally contextualized playlist starting 2 minutes before and continuing during a 30-second dental drilling period. Physiological parameters (heart rate and blood pressure) and perceived pain intensity are recorded to assess the effects of the music intervention on pain and stress responses. | Behavioural | Music Listening During Dental Procedure (Within-Subject Design) |
| Control Condition - Silence (Post-Music Phase)Participants undergo a second 30-second dental drilling period without music following the intervention phase. Physiological parameters and perceived pain intensity are recorded to evaluate post-intervention effects and return to baseline conditions. | Behavioural | Music Listening During Dental Procedure (Within-Subject Design) |
Primary outcome
Perceived Pain Intensity
Time frame: At T0 (before the procedure), at T1 (30seconds after initiation of drilling, pre-music), at T2 (150seconds after initiation of the procedure,during music), at T3 (330seconds after initiation of the procedure,post-music) within a single treatment session.
Participants report their pain level during each phase of the dental drilling procedure using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable).
3 secondary outcomes
Heart Rate
Time frame: Baseline (before the procedure), T1 (30 seconds after initiation of drilling, pre-music), T2 (150 seconds after initiation of the procedure, during music), T3 (330 seconds after initiation of the procedure, after music) within a single treatment session.
Blood Pressure (Systolic and Diastolic)
Time frame: Baseline (before the procedure), T1 (30 seconds after initiation of drilling, pre-music), T2 (150 seconds after initiation of the procedure, during music), T3 (330 seconds after initiation of the procedure, after music) within a single treatment session.
Post-Treatment Perception of Music Effectiveness
Time frame: Measured immediately after the dental procedure (post-treatment).
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 21 Apr 2026.
- Background: PubMed 24552785Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666.
- Background: PubMed 25709291Singh D, Samadi F, Jaiswal J, Tripathi AM. Stress Reduction through Audio Distraction in Anxious Pediatric Dental Patients: An Adjunctive Clinical Study. Int J Clin Pediatr Dent. 2014 Sep-Dec;7(3):149-52. doi: 10.5005/jp-journals-10005-1254. Epub 2015 Feb 9.
- Background: PubMed 26573456Mejia-Rubalcava C, Alanis-Tavira J, Mendieta-Zeron H, Sanchez-Perez L. Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complement Ther Clin Pract. 2015 Nov;21(4):282-6. doi: 10.1016/j.ctcp.2015.10.005. Epub 2015 Oct 27.
- Background: PubMed 27819961Moola S, Pearson A, Hagger C. Effectiveness of music interventions on dental anxiety in paediatric and adult patients: a systematic review. JBI Libr Syst Rev. 2011;9(18):588-630. doi: 10.11124/01938924-201109180-00001.
- Background: PubMed 18808630Lai HL, Hwang MJ, Chen CJ, Chang KF, Peng TC, Chang FM. Randomised controlled trial of music on state anxiety and physiological indices in patients undergoing root canal treatment. J Clin Nurs. 2008 Oct;17(19):2654-60. doi: 10.1111/j.1365-2702.2008.02350.x.
- Background: PubMed 18310736Lahmann C, Schoen R, Henningsen P, Ronel J, Muehlbacher M, Loew T, Tritt K, Nickel M, Doering S. Brief relaxation versus music distraction in the treatment of dental anxiety: a randomized controlled clinical trial. J Am Dent Assoc. 2008 Mar;139(3):317-24. doi: 10.14219/jada.archive.2008.0161.
- Background: PubMed 5254211Gabai M. [Sound therapy and sophrology]. Inf Dent. 1969 Jun 12;51(24):2443-55. No abstract available. French.
- Individual participant dataSharing planned: No
Related trials for Dental Pain
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Pain Perception With Cordless Electronic Local Anesthetic Delivery System
Decayed Primary Molars
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Assessment (T0) and Music Listening Condition (Intervention Phase) in people with Dental Pain and Dental Anxiety, run by Rawane El Dimachki at 1 site in Lebanon.
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 3 inclusion and 5 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 21 Apr 2026. 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 Lebanon. 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?
Perceived Pain Intensity (time frame: At T0 (before the procedure), at T1 (30seconds after initiation of drilling, pre-music), at T2 (150seconds after initiation of the procedure,during music), at T3 (330seconds after initiation of the procedure,post-music) within a single treatment session.). 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 NCT07543042, which also lists 7 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 21 Apr 2026.