Effect of Aromatherapy and Music Therapy on Physiological Response and Pain During Mandibular Third Molar Extraction (AROMUSIC-M3)
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).
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Lima Province
-
Lima、Lima Province、ペルー、Lima 15082
- Hospital Nacional Arzobispo Loayza - HNAL
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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).
|
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.
他の名前：
|
|
実験的：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).
|
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.
|
|
介入なし：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart Rate
時間枠：Before intervention and immediately after surgery
|
Heart rate measured in beats per minute (bpm).
|
Before intervention and immediately after surgery
|
|
Systolic Blood Pressure
時間枠：Before intervention and immediately after surgery
|
Systolic blood pressure measured in mmHg.
|
Before intervention and immediately after surgery
|
|
Diastolic Blood Pressure
時間枠：Before intervention and immediately after surgery
|
Diastolic blood pressure measured in mmHg.
|
Before intervention and immediately after surgery
|
|
Oxygen Saturation
時間枠：Before intervention and immediately after surgery
|
Peripheral oxygen saturation measured by pulse oximetry.
|
Before intervention and immediately after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intraoperative Pain (VAS)
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1240-CIEI-CIENTÍFICA-2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。