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

NCT06998979 | Completed DMC

• 1 other identifier: USUCMUSIC2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth Extraction; Molar, Third

Keywords

Third molar extraction; Music therapy; Anxiety

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline and immediately after surgery

• 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.

  Baseline and immediately after surgery

• 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.

  Baseline and immediately after surgery

• 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.

  Immediately after surgery

Secondary Outcomes (4)

• Body temperature

  Baseline and immediately after surgery

• Heart rate

  Baseline and immediately after surgery

• Blood pressure

  Baseline and immediately after the surgery

• Oxygen saturation

  Baseline and immediately after the surgery

Study Arms (2)

Music therapy

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

Music therapy BEHAVIORAL

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.

Music therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Coimbra: lead
• University of Salamanca: collaborator

Study Sites (1)

Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jose Antonio B Rueda, PhD

  University of Salamanca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 31, 2025
• Study Start: December 4, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Locations

ES (1)