- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07543042
Evaluation of the Sedative Effect of Contextualized Music Listening on Patient Pain and Anxiety in a Dental Care Setting
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:
- 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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mount Lebanon
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Baabda, Mount Lebanon, Lebanon
- Private Dental Clinic of Dr. Mhammad El Dimachki
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients aged 18 to 60 years.
- Visiting the dental clinic for treatment of dental caries.
- Able to provide written informed consent.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Listening During Dental Procedure (Within-Subject Design)
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.
|
Measurement of baseline physiological parameters (heart rate, systolic and diastolic blood pressure) prior to the dental procedure, without any auditory stimulation or dental drilling.
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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Participants' heart rate is continuously monitored using a pulse sensor throughout the procedure to evaluate autonomic nervous system responses.
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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.
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Systolic and diastolic blood pressure are measured as indicators of physiological stress during each phase of the dental procedure.
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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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Post-Treatment Perception of Music Effectiveness
Time Frame: Measured immediately after the dental procedure (post-treatment).
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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).
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Koelsch, S. (2014). Brain correlates of music-evoked emotions. Nat Rev Neurosci, 15(3), 170-180. https://doi.org/10.1038/nrn3666.
- Singh, D., Samadi, F., Jaiswal, J., & Tripathi, A. M. (2014). Stress Reduction through Audio Distraction in Anxious Pediatric Dental Patients: An Adjunctive Clinical Study. International Journal of Clinical Pediatric Dentistry, 7(3), 149-152. https://doi.org/10.5005/jp-journals-10005-1254
- Mejía-Rubalcava, C., Alanís-Tavira, J., Mendieta-Zerón, H., & Sánchez-Pérez, L. (2015). Changes induced by music therapy to physiologic parameters in patients with dental anxiety. Complementary Therapies in Clinical Practice, 21(4), 282-286. https://doi.org/10.1016/j.ctcp.2015.10.005
- Moola, S., Pearson, A., & Hagger, C. (2011). Effectiveness of music interventions on dental anxiety in paediatric and adult patients: A systematic review. JBI Library of Systematic Reviews, 9(18), 588 630. https://doi.org/10.11124/01938924-201109180-00001
- Lai, H.-L., Hwang, M.-J., Chen, C.-J., Chang, K.-F., Peng, T.-C., & Chang, F.-M. (2008). Randomised controlled trial of music on state anxiety and physiological indices in patients undergoing root canal treatment. Journal of Clinical Nursing, 17(19), 2654-2660. https://doi.org/10.1111/j.1365 2702.2008.02350.x
- Lahmann, C., Schoen, R., Henningsen, P., Ronel, J., Muehlbacher, M., Loew, T., Tritt, K., Nickel, M., & Doering, S. (2008). Brief relaxation versus music distraction in the treatment of dental anxiety: A randomized controlled clinical trial. Journal of the American Dental Association, 139(3), 317-324. https://doi.org/10.14219/jada.archive.2008.0161
- Gabai, M. (1969). Thérapie par les sons et sophrologie. Information Dentaire, 24, 443-445.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1606-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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