Aromatherapy and Music Therapy for Anxiety Management During Mandibular Third Molar Extraction (AROMUSIC-M3)

Effectiveness of Aromatherapy and Music Therapy for Anxiety Management in Patients Undergoing Mandibular Third Molar Extraction

The goal of this clinical trial is to compare the effects of aromatherapy and music therapy on dental anxiety and physiological responses in patients with moderate to severe dental anxiety undergoing mandibular third molar extraction. The main questions it aims to answer are:

• Do aromatherapy and music therapy improve anxiety-related outcomes in patients with moderate to severe dental anxiety?
• Are there differences between aromatherapy and music therapy in their effects on physiological parameters during mandibular third molar extraction? Researchers will compare an aromatherapy group and a music therapy group with a control group to determine whether these interventions improve anxiety-related outcomes and physiological responses.

Participants will:

• Complete the Modified Dental Anxiety Scale (MDAS) before and after surgery.
• Receive aromatherapy, music therapy, or standard care for five minutes before the surgical procedure.
• Undergo measurement of blood pressure, heart rate, and oxygen saturation before and after surgery.
• Report intraoperative pain using a visual analog scale (VAS).

Study Overview

• Status: Completed
• Conditions: Dental Anxiety; Third Molar Extraction Surgery
• Intervention / Treatment: Behavioral: Aromatherapy; Behavioral: Music Therapy

Detailed Description

Dental anxiety is common among patients undergoing oral surgical procedures and may be associated with physiological responses that can negatively affect the patient's treatment experience. Mandibular third molar extraction is one of the most frequently performed oral surgical procedures and is often associated with moderate to severe levels of dental anxiety.

Aromatherapy and music therapy have been proposed as non-pharmacological interventions to reduce anxiety in dental settings because of their low cost, ease of implementation, and minimal risk. However, evidence comparing the effectiveness of these interventions during mandibular third molar extraction remains limited.

This clinical trial was conducted in a public hospital and included adult patients with moderate to severe dental anxiety who underwent mandibular third molar extraction. Participants were allocated to an aromatherapy group, a music therapy group, or a control group using a non-randomized allocation method. Group distribution was balanced according to sex. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were recorded before and after surgery. Intraoperative pain was also evaluated using a Visual Analog Scale (VAS).

Clinical characteristics considered in the study included age, sex, abdominal obesity, surgical duration, and mandibular third molar position according to Winter's classification (vertical, mesioangular, and horizontal).

The objective of this study was to compare the effects of aromatherapy and music therapy on dental anxiety and anxiety-related physiological responses and to provide evidence regarding the usefulness of these non-pharmacological interventions in patients undergoing mandibular third molar extraction.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima Province
    • Lima, Lima Province, Peru, Lima 15082
      • Hospital Nacional Arzobispo Loayza - HNAL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18-38 years.
• Scheduled for mandibular third molar extraction.
• ASA I or ASA II patients.
• Moderate to severe dental anxiety according to MDAS.

Exclusion Criteria:

• Diagnosis of anxiety, depression, or psychiatric disorders.
• Use of antidepressants, antipsychotics, anticonvulsants, beta-blockers, sedatives, or anxiolytics.
• Pregnancy.
• Cognitive, visual, hearing, or language impairment interfering with questionnaire completion.
• Use of sedatives or anxiolytics within 12 hours before surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aromatherapy; Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction inhaled 1 mL of lavender essential oil through a gauze pad placed approximately 2 cm from the nose, avoiding direct contact, for 5 minutes before surgery. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery.	Behavioral: Aromatherapy; Participants inhaled 1 mL of lavender essential oil through a gauze pad positioned approximately 2 cm from the nose, avoiding direct contact, for 5 minutes before mandibular third molar extraction.; Other Names: Lavender Aromatherapy; Lavender Essential Oil
Experimental: Music Therapy; Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction listened to Rachmaninoff's Symphony No. 2, Op. 27, III. Adagio through wireless headphones for 5 minutes before surgery. The listening volume was selected by each participant according to personal preference. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery.	Behavioral: Music Therapy; Participants listened to Rachmaninoff - Symphony No. 2, Op. 27, III. Adagio through wireless headphones for 5 minutes before mandibular third molar extraction. The listening volume was selected by the participant.
No Intervention: Control; Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction received standard preoperative care without aromatherapy or music therapy. Dental anxiety was assessed before and after surgery using the Modified Dental Anxiety Scale (MDAS). Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental Anxiety (MDAS Score)	Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS). The total score ranges from 5 to 25, with higher scores indicating greater anxiety.	Immediately before surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate measured in beats per minute (bpm).	Before intervention and immediately after surgery
Systolic Blood Pressure	Systolic blood pressure measured in mmHg.	Before intervention and immediately after surgery
Diastolic Blood Pressure	Diastolic blood pressure measured in mmHg.	Before intervention and immediately after surgery
Oxygen Saturation	Peripheral oxygen saturation measured by pulse oximetry.	Before intervention and immediately after surgery
Postoperative Pain (VAS)	Pain assessed using a Visual Analog Scale (VAS) from 0 to 10.	Immediately after surgery

Collaborators and Investigators

• Sponsor: Universidad Científica del Sur

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Actual): June 2, 2026
• Study Completion (Actual): June 2, 2026

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Music Therapy; Aromatherapy; Dental Anxiety; Non-Pharmacological Intervention; Third molar extraction surgery
• Additional Relevant MeSH Terms: Therapeutics; Mind-Body Therapies; Complementary Therapies; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Rehabilitation; Aftercare; Continuity of Patient Care; Sensory Art Therapies; Phytotherapy; Music Therapy; Aromatherapy; lavender oil
• Other Study ID Numbers: 1240-CIEI-CIENTÍFICA-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the informed consent obtained from participants did not include authorization for public data sharing. Participant confidentiality and privacy will be protected in accordance with institutional and ethical requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No