Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

15 juli 2026 uppdaterad av: 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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

102

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Beteende: 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.
Andra namn:
  • Lavender Aromatherapy
  • Lavender Essential Oil
Experimentell: 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).
Beteende: 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.
Inget ingripande: 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).

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Intraoperative Pain (VAS)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Universidad Científica del Sur

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 mars 2026

Primärt slutförande (Faktisk)

2 juni 2026

Avslutad studie (Faktisk)

2 juni 2026

Studieregistreringsdatum

Först inskickad

9 juni 2026

Först inskickad som uppfyllde QC-kriterierna

9 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

17 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1240-CIEI-CIENTÍFICA-2025

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera