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Effect of Aromatherapy and Music Therapy on Physiological Response and Pain During Mandibular Third Molar Extraction (AROMUSIC-M3)

15 juli 2026 bijgewerkt door: Julissa A. Dulanto-Vargas, Universidad Científica del Sur

The goal of this clinical trial is to compare the effects of aromatherapy and music therapy on physiological responses and intraoperative pain 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 physiological responses during mandibular third molar extraction?
  • Are there differences between aromatherapy and music therapy in their effects on physiological parameters and intraoperative pain 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 physiological responses and reduce intraoperative pain.

Participants will:

  • Complete the Modified Dental Anxiety Scale (MDAS) before surgery to determine eligibility.
  • 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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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 that may improve physiological responses and reduce pain during dental procedures 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. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. 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. 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 physiological responses and intraoperative pain during mandibular third molar extraction and to provide evidence regarding the usefulness of these non-pharmacological interventions in clinical practice.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

102

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. Intraoperative pain was assessed using a Visual Analog Scale (VAS).
Gedragsmatig: 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.
Andere namen:
  • Lavender Aromatherapy
  • Lavender Essential Oil
Experimenteel: 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. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. Intraoperative pain was assessed using a Visual Analog Scale (VAS).
Gedragsmatig: 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.
Geen tussenkomst: Control
Participants with moderate to severe dental anxiety undergoing mandibular third molar extraction received standard preoperative care without aromatherapy or music therapy. Eligibility was determined using the Modified Dental Anxiety Scale (MDAS), which was administered before surgery. Physiological parameters, including systolic blood pressure, diastolic blood pressure, heart rate, and oxygen saturation, were measured before and after surgery. Intraoperative pain was assessed using a Visual Analog Scale (VAS).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart Rate
Tijdsspanne: Before intervention and immediately after surgery
Heart rate measured in beats per minute (bpm).
Before intervention and immediately after surgery
Systolic Blood Pressure
Tijdsspanne: Before intervention and immediately after surgery
Systolic blood pressure measured in mmHg.
Before intervention and immediately after surgery
Diastolic Blood Pressure
Tijdsspanne: Before intervention and immediately after surgery
Diastolic blood pressure measured in mmHg.
Before intervention and immediately after surgery
Oxygen Saturation
Tijdsspanne: Before intervention and immediately after surgery
Peripheral oxygen saturation measured by pulse oximetry.
Before intervention and immediately after surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Intraoperative Pain (VAS)
Tijdsspanne: Immediately after surgery
Pain experienced during mandibular third molar extraction, assessed immediately after surgery using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity (worse outcome).
Immediately after surgery

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidad Científica del Sur

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 maart 2026

Primaire voltooiing (Werkelijk)

2 juni 2026

Studie voltooiing (Werkelijk)

2 juni 2026

Studieregistratiedata

Eerst ingediend

9 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juni 2026

Eerst geplaatst (Werkelijk)

15 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

15 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1240-CIEI-CIENTÍFICA-2025

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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