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| Name | Class |
|---|---|
| University of Salamanca | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control | No Intervention | In the control group, third molar extraction was performed without the application of any music. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and immediately after surgery |
| Heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Antonio B Rueda, PhD | University of Salamanca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca | Salamanca | Salamanca | 37007 | Spain |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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). |
| Baseline and immediately after surgery |
| 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). | Baseline and immediately after the surgery |
| 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 (%). | Baseline and immediately after the surgery |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |