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CompletedNCT07543042Updated Apr 21, 2026

Evaluation of the Sedative Effect of Contextualized Music Listening on Patient Pain and Anxiety in a Dental Care Setting

An interventional study of Baseline Assessment (T0) and Control Condition - Silence (Pre-Music Phase) in Dental Pain and Dental Anxiety, sponsored by Rawane El Dimachki. Completed at 1 site in Lebanon. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Rawane El Dimachki · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2025, registered Mar 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Pain
  • Dental Anxiety

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Keywords

  • Music therapy
  • Dental pain
  • Dental anxiety
  • analgesia
  • non-pharmacological intervention
  • heart rate
  • blood pressure
  • stress response
03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's enrollment of 30 is below the median of 84 across 123 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Rawane El Dimachki is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients who do not provide written .
  • Children (under 18 years of age).
  • Patients with known mental or physical disorders.
  • Pregnant women.
  • Patients currently taking analgesics, anxiolytics, or antidepressants.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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.

    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

  • BehavioralBaseline 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.

  • BehavioralControl 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.

  • BehavioralMusic 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.

  • BehavioralControl 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.

06

What researchers measure

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).

    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.

Secondary outcomes

  1. Heart Rate

    Participants' heart rate is continuously monitored using a pulse sensor throughout the procedure to evaluate autonomic nervous system responses.

    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.

  2. Blood Pressure (Systolic and Diastolic)

    Systolic and diastolic blood pressure are measured as indicators of physiological stress during each phase of the dental procedure.

    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.

  3. 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).

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

07

Study locations

1 site
  • Private Dental Clinic of Dr. Mhammad El Dimachki
    Baabda, Mount Lebanon, Lebanon
08

References and documents

Publications

  • Koelsch S. Brain correlates of music-evoked emotions. Nat Rev Neurosci. 2014 Mar;15(3):170-80. doi: 10.1038/nrn3666. PubMed 24552785 ↗
  • 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. PubMed 25709291 ↗
  • 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. PubMed 26573456 ↗
  • 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. PubMed 27819961 ↗
  • 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. PubMed 18808630 ↗
  • 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. PubMed 18310736 ↗
  • Gabai M. [Sound therapy and sophrology]. Inf Dent. 1969 Jun 12;51(24):2443-55. No abstract available. French. PubMed 5254211 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07543042
Lead sponsor
Rawane El Dimachki
Collaborators
Sorbonne University
Responsible party
Rawane El Dimachki (Chairperson of the department of music therapy, Antonine University) — Sponsor-investigator
First posted
Apr 21, 2026
Start date
Oct 1, 2025
Primary completion
Oct 1, 2025
Completion
Dec 23, 2025
Last update
Apr 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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