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| Name | Class |
|---|---|
| Sorbonne University | OTHER |
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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:
Researchers will compare periods with and without music during the same dental procedure to evaluate the effect of the musical intervention.
Participants will:
The study includes 30 adult participants and is conducted in a private dental clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baseline Assessment (T0) | Behavioral | Measurement of baseline physiological parameters (heart rate, systolic and diastolic blood pressure) prior to the dental procedure, without any auditory stimulation or dental drilling. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Participants' heart rate is continuously monitored using a pulse sensor throughout the procedure to evaluate autonomic nervous system responses. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Dental Clinic of Dr. Mhammad El Dimachki | Baabda | Mount Lebanon | Lebanon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24552785 | Background | Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666. | |
| 25709291 | Background | Singh 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2026 | |
| Reset | May 13, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2025 |
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| Control Condition - Silence (Pre-Music Phase) | Behavioral | 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. |
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| Music Listening Condition (Intervention Phase) | Behavioral | 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. |
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| Control Condition - Silence (Post-Music Phase) | Behavioral | 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. |
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| Blood Pressure (Systolic and Diastolic) | Systolic and diastolic blood pressure are measured as indicators of physiological stress during each phase of the dental procedure. | 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 immediately after the dental procedure (post-treatment). |
| 26573456 | Background | Mejia-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. |
| 27819961 | Background | Moola 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. |
| 18808630 | Background | Lai 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. |
| 18310736 | Background | Lahmann 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. |
| 5254211 | Background | Gabai M. [Sound therapy and sophrology]. Inf Dent. 1969 Jun 12;51(24):2443-55. No abstract available. French. |
| Mar 31, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 19, 2025 | Mar 31, 2026 | ICF_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2026 | May 13, 2026 |
| ID | Term |
|---|---|
| D014098 | Toothache |
| D000377 | Agnosia |
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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