- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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).
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Lima Province
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Lima, Lima Province, Peru, Lima 15082
- Hospital Nacional Arzobispo Loayza - HNAL
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
|
Experimentální: 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.
|
|
Žádný zásah: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Dental Anxiety (MDAS Score)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Heart Rate
Časové okno: Before intervention and immediately after surgery
|
Heart rate measured in beats per minute (bpm).
|
Before intervention and immediately after surgery
|
|
Systolic Blood Pressure
Časové okno: Before intervention and immediately after surgery
|
Systolic blood pressure measured in mmHg.
|
Before intervention and immediately after surgery
|
|
Diastolic Blood Pressure
Časové okno: Before intervention and immediately after surgery
|
Diastolic blood pressure measured in mmHg.
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Before intervention and immediately after surgery
|
|
Oxygen Saturation
Časové okno: Before intervention and immediately after surgery
|
Peripheral oxygen saturation measured by pulse oximetry.
|
Before intervention and immediately after surgery
|
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Postoperative Pain (VAS)
Časové okno: Immediately after surgery
|
Pain assessed using a Visual Analog Scale (VAS) from 0 to 10.
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Immediately after surgery
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 1240-CIEI-CIENTÍFICA-2025
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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