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CompletedNCT06998979Updated May 31, 2025

Efficacy of Artificial Intelligence-Generated Music Therapy in Reducing Dental Anxiety Among Adults Undergoing Impacted Third Molar Extraction

An interventional study of Music therapy in Tooth Extraction and Molar, Third, sponsored by University of Coimbra. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-31.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by University of Coimbra · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2024, registered May 2025).

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Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Music therapy is widely used in dentistry as it helps patients remain distracted during procedures, particularly during implant placement or third molar extraction. This therapy refers to the evidence-based clinical use of music to achieve therapeutic goals, administered by a licensed practitioner. Due to the high prevalence of complications associated with the eruption and development of wisdom teeth, there has been an increase in the rate of surgical extractions, which in turn elevates patients' dental anxiety. Music therapy may aid in the management of anxiety and thereby contribute to a reduction in pain perception. It is a favorable technique due to its low cost and minimal associated risks. In this context, and considering the widespread use of music as a therapeutic tool alongside the emergence of novel technologies-particularly Artificial Intelligence (AI)-this study aims to evaluate the efficacy of AI-generated music therapy in reducing dental anxiety during impacted third molar extraction procedures.

02

Conditions studied

  • Tooth Extraction
  • Molar, Third

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Keywords

  • Third molar extraction
  • Music therapy
  • Anxiety
03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

University of Coimbra is the lead sponsor of 89 studies on the registry; 26 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
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

  • Patients over 18 years of age who provided
  • Patients without severe or uncontrolled systemic diseases
  • Patients capable of completing the dental anxiety questionnaires

Exclusion criteria

Exclusion Criteria:

  • Patients under 18 years of age
  • Patients with severe or uncontrolled systemic diseases
  • Patients using anxiolytic medications
  • Patients unable to complete the dental anxiety questionnaires
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
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Music therapy

    Patients in the experimental group listened to the music via ambient diffusion from a computer located in the surgical room throughout the entire procedure.

    Behavioral: Music therapy

  • No intervention
    Control

    In the control group, third molar extraction was performed without the application of any music.

Interventions

  • BehavioralMusic therapy

    The music was generated using a beta version of the RIFFUSION program, which is still in its development phase and being refined based on user input. This software operates using neural networks similar to Generative Adversarial Networks (GANs), known as diffusion models. These models begin with random noise and gradually transform it into a musical composition through a process that involves two phases: a diffusion phase-where an existing musical sample is "disordered" by adding random noise-and a reverse phase, in which the noise is removed to reconstruct a new and distinct musical piece. The prompt entered into the program was: "Relaxing slow music for people with great stress and extreme anxiety and panic caused by dental surgery with effects of wind and waterfall." A total of 20 songs were generated and merged to achieve a combined duration of 49.20 minutes.

06

What researchers measure

Primary outcomes

  1. Corah's Dental Anxiety Scale

    The Corah's Dental Anxiety Scale (CDAS) is a reliable instrument for assessing dental anxiety in adults. It consists of four questions addressing different dental situations. Each question is scored on a scale from 1 (not anxious) to 5 (extremely anxious), resulting in a total score ranging from 4 to 20. A score of 15 or higher indicates severe dental anxiety.

    Time frame: Baseline and immediately after surgery

  2. Modified Dental Anxiety Scale

    The Modified Dental Anxiety Scale (MDAS) is a concise, self-administered questionnaire designed to assess levels of dental anxiety. It comprises five items, each rated on a five-point Likert scale ranging from "not anxious" to "extremely anxious." The total score is obtained by summing the individual item scores, yielding a range from 5 to 25.

    Time frame: Baseline and immediately after surgery

  3. Spielberger State-Trait Anxiety Inventory

    The Spielberger State-Trait Anxiety Inventory is a widely recognized psychological instrument for assessing anxiety. It comprises 40 items divided into two subscales: state anxiety, which captures how an individual feels at a particular moment, and trait anxiety, which reflects general, long-term tendencies toward anxiety. Each item is rated on a four-point scale, with higher scores indicating greater levels of anxiety.

    Time frame: Baseline and immediately after surgery

  4. Pain Intensity

    To assess perceived pain during the procedure, the Visual Analog Scale (VAS) was used. This scale provides a subjective measure of pain intensity, ranging from 0 to 10, with higher values indicating greater pain.

    Time frame: Immediately after surgery

Secondary outcomes

  1. Body temperature

    Body temperature reflects the body's ability to regulate heat and maintain homeostasis. It will be measured using a digital thermometer placed axillary (underarm), The body temperature will be measurement in degrees Celsius (°C).

    Time frame: Baseline and immediately after surgery

  2. Heart rate

    Heart rate refers to the number of heartbeats per minute and serves as an indicator of cardiovascular function. It will be measured using a heart rate monitor. The unit of measurement is beats per minute (bpm).

    Time frame: Baseline and immediately after surgery

  3. Blood pressure

    Blood pressure indicates the force exerted by circulating blood on the walls of the arteries. It will be measured using a digital sphygmomanometer placed around the upper arm. The unit of measurement is millimeters of mercury (mmHg), and it will be recorded as systolic over diastolic pressure (e.g., 120/80 mmHg).

    Time frame: Baseline and immediately after the surgery

  4. Oxygen saturation

    Oxygen saturation refers to the percentage of oxygen-saturated hemoglobin in the blood. It will be measured non-invasively using a pulse oximeter placed on the fingertip. The unit of measurement is percentage (%).

    Time frame: Baseline and immediately after the surgery

07

Study locations

1 site
  • Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca
    Salamanca, Salamanca 37007, Spain
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2024 to primary completion in Feb 2025, 2 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 2 months is below that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2025
First posted
May 31, 2025
StartActual
Dec 4, 2024
Primary completionActual
Feb 20, 2025
CompletionActual
Feb 20, 2025
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06998979
Lead sponsor
University of Coimbra
Responsible party
Bruno Macedo de Sousa (Professor, University of Coimbra) — Principal investigator
First posted
May 31, 2025
Start date
Dec 4, 2024
Primary completion
Feb 20, 2025
Completion
Feb 20, 2025
Last update
May 31, 2025

Study contacts

Jose Antonio B Rueda, PhD
principal investigator · University of Salamanca

Oversight

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

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