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

9 giugno 2026 aggiornato da: Julissa A. Dulanto-Vargas, Universidad Científica del Sur

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).

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

102

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Altri nomi:
  • Lavender Aromatherapy
  • Lavender Essential Oil
Sperimentale: 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.
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.
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Dental Anxiety (MDAS Score)
Lasso di tempo: Immediately before surgery
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Heart Rate
Lasso di tempo: Before intervention and immediately after surgery
Heart rate measured in beats per minute (bpm).
Before intervention and immediately after surgery
Systolic Blood Pressure
Lasso di tempo: Before intervention and immediately after surgery
Systolic blood pressure measured in mmHg.
Before intervention and immediately after surgery
Diastolic Blood Pressure
Lasso di tempo: Before intervention and immediately after surgery
Diastolic blood pressure measured in mmHg.
Before intervention and immediately after surgery
Oxygen Saturation
Lasso di tempo: Before intervention and immediately after surgery
Peripheral oxygen saturation measured by pulse oximetry.
Before intervention and immediately after surgery
Postoperative Pain (VAS)
Lasso di tempo: Immediately after surgery
Pain assessed using a Visual Analog Scale (VAS) from 0 to 10.
Immediately after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 marzo 2026

Completamento primario (Effettivo)

2 giugno 2026

Completamento dello studio (Effettivo)

2 giugno 2026

Date di iscrizione allo studio

Primo inviato

9 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 giugno 2026

Primo Inserito (Effettivo)

15 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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