Effect of Aromatherapy and Music Therapy on Physiological Response and Pain During Mandibular Third Molar Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Dental Anxiety (MDAS Score)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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).
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).
干预措施: Aromatherapy (Behavioral)
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).
干预措施: Music Therapy (Behavioral)
结局指标
主要结局
Dental Anxiety (MDAS Score)
时间窗: 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 (worse outcome).
Heart Rate
时间窗: Before intervention and immediately after surgery
Heart rate measured in beats per minute (bpm).
Oxygen Saturation
时间窗: Before intervention and immediately after surgery
Peripheral oxygen saturation measured by pulse oximetry.
Diastolic Blood Pressure
时间窗: Before intervention and immediately after surgery
Diastolic blood pressure measured in mmHg.
Systolic Blood Pressure
时间窗: Before intervention and immediately after surgery
Systolic blood pressure measured in mmHg.
次要结局
- Heart Rate(Before intervention and immediately after surgery)
- Systolic Blood Pressure(Before intervention and immediately after surgery)
- Diastolic Blood Pressure(Before intervention and immediately after surgery)
- Oxygen Saturation(Before intervention and immediately after surgery)
- Postoperative Pain (VAS)(Immediately after surgery)
- Intraoperative Pain (VAS)(Immediately after surgery)
研究者
Julissa A. Dulanto-Vargas
Research Professor
Universidad Científica del Sur