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NCT Number: NCT07543042

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

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.

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Key information

Conditions

Dental Pain Agnosia Dental Anxiety Facial Pain Fractures, Bone Fractures, Stress Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Dental Clinic of Dr. Mhammad El Dimachki

Baabda, Mount Lebanon, Lebanon

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

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

  3. Post-Treatment Perception of Music Effectiveness

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

    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).

Sponsors and collaborators

Lead sponsor

Rawane El Dimachki

Other

Collaborators

  • Sorbonne University

Registry information

Official study title

Musical Grammatological and Neurocognitive Parameterization of Analgesic and Anxiolytic Effects of Culturally and Personally Contextualized Music Listening During Painful Dental Procedures

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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