- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07647419
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).
Panoramica dello studio
Stato
Intervento / Trattamento
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
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Lima Province
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Lima, Lima Province, Perù, Lima 15082
- Hospital Nacional Arzobispo Loayza - HNAL
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
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
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 |
|---|---|
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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.
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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:
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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.
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dental Anxiety (MDAS Score)
Lasso di tempo: Immediately before surgery
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Dental anxiety assessed using the Modified Dental Anxiety Scale (MDAS).
The total score ranges from 5 to 25, with higher scores indicating greater anxiety.
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Immediately before surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Heart Rate
Lasso di tempo: Before intervention and immediately after surgery
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Heart rate measured in beats per minute (bpm).
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Before intervention and immediately after surgery
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Systolic Blood Pressure
Lasso di tempo: Before intervention and immediately after surgery
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Systolic blood pressure measured in mmHg.
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Before intervention and immediately after surgery
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Diastolic Blood Pressure
Lasso di tempo: Before intervention and immediately after surgery
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Diastolic blood pressure measured in mmHg.
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Before intervention and immediately after surgery
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Oxygen Saturation
Lasso di tempo: Before intervention and immediately after surgery
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Peripheral oxygen saturation measured by pulse oximetry.
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Before intervention and immediately after surgery
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Postoperative Pain (VAS)
Lasso di tempo: Immediately after surgery
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Pain assessed using a Visual Analog Scale (VAS) from 0 to 10.
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Immediately after surgery
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Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1240-CIEI-CIENTÍFICA-2025
Piano per i dati dei singoli partecipanti (IPD)
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