NCT07543042

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

March 26, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

Music therapyDental painDental anxietyanalgesianon-pharmacological interventionheart rateblood pressurestress response

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (3)

  • Heart Rate

    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)

    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

    Measured immediately after the dental procedure (post-treatment).

Study Arms (1)

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.

Behavioral: Baseline Assessment (T0)Behavioral: Control Condition - Silence (Pre-Music Phase)Behavioral: Music Listening Condition (Intervention Phase)Behavioral: Control Condition - Silence (Post-Music Phase)

Interventions

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.

Music Listening During Dental Procedure (Within-Subject Design)

Measurement of baseline physiological parameters (heart rate, systolic and diastolic blood pressure) prior to the dental procedure, without any auditory stimulation or dental drilling.

Music Listening During Dental Procedure (Within-Subject Design)

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 During Dental Procedure (Within-Subject Design)

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.

Music Listening During Dental Procedure (Within-Subject Design)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged 18 to 60 years.
  • Visiting the dental clinic for treatment of dental caries.
  • Able to provide written informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Dental Clinic of Dr. Mhammad El Dimachki

Baabda, Mount Lebanon, Lebanon

Location

Related Publications (7)

  • Koelsch, S. (2014). Brain correlates of music-evoked emotions. Nat Rev Neurosci, 15(3), 170-180. https://doi.org/10.1038/nrn3666.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Gabai, M. (1969). Thérapie par les sons et sophrologie. Information Dentaire, 24, 443-445.

    BACKGROUND

MeSH Terms

Conditions

ToothacheAgnosiaFractures, Stress

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesFractures, BoneWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairperson of the department of music therapy

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 21, 2026

Study Start

October 1, 2025

Primary Completion

October 1, 2025

Study Completion

December 23, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations