Pain Perception and Emotional Changes On The Relationships Between Dental Anxiety And Olfaction: A Double-blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
Introduction: This prospective study aimed to assess the impact of olfaction on providing positive emotional responses and reducing dental anxiety and pain.
Material: A randomized double-blinded controlled study was enrolled on female patients. The olfaction was stimulated via lavender essential oils. Patients were divided into lavender and control groups. Patients in lavender group inhaled 2 % lavender vapors. In control group, patients inhaled distal water vapors. The variables included pain, anxiety, and vital signs. Anxiety was measured through Modified Dental Anxiety Scale (MDAS) and Speilberger State-Trait Anxiety Inventory (STAI) questionnaires. Pain was evaluated through visual analog scales (VAS). Vital signs included the systolic (SBP) and diastolic blood pressure (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). All variables were assessed before the intervention, 20 minutes after inhalation of vapors, and at the end of dental settings. The last evaluation was on the day after visits. P-values < 0.05 were considered significant.
详细描述
ABSTRACT:
Background: The purpose of the study was to determine to what extent olfactory aromatherapy reduces the intensity of dental pain and the level of dental anxiety. It also attempted to corelate between olfactory aromatherapy, stages of dental visits, and various dental procedures.
Methods: Female patients were enrolled in a randomized controlled study. Olfactory aromatherapy was performed using lavender oils. Patients were randomly assigned to one of two groups: the lavender group, in which patients inhaled 2% lavender vapors, and the control group, in which patients inhaled water vapors. Pain score, anxiety score, and changes in vital signs were among the predictable variables. Anxiety and pain were assessed using the Modified Dental Anxiety Scale (MDAS), Speilberger State-Trait Anxiety Inventory (STAI), and visual analog scales (VAS). The vital signs were systolic (SBP) and diastolic (DBP), heart rate (HR), respiratory rate (RR), and oxygen saturation (Spo2). Variables were evaluated before inhalations, 20 minutes after inhalations, at the end of settings, and on the following day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult females over 18 years,
- •Attending morning sessions of clinics (9 am),
- •Liable for administration of local anesthesia, tooth preparation either for:
- •Filling procedures or crown preparations
- •Endodontic treatment
- •Teeth extraction
- •Eubgingival scaling
排除标准
- •Females who had:
- •Bronchial asthma
- •Common cold
- •Pulmonary diseases
- •Females who taking:
- •Antidepressants
- •Anxiolytic drugs
- •Other medications that affect emotional responses
- •Pregnant females
研究组 & 干预措施
Lavender group
Patients who were included in this group were subjected to vapors of the lavender oil in waiting rooms, during dental therapy, and on day after dental procedures
干预措施: Lavender Oil (Drug)
Control group
Patients who were included in this group were subjected to vapors of distal water in waiting rooms and during dental therapy
干预措施: Distal Water (Drug)
结局指标
主要结局
Pain Score
时间窗: 20 minutes after exposure
Measured by a visual analog scale (VAS).These pain scales give people a simple way to rate their pain intensity using a verbal or visual descriptor of their pain. Some examples would be the words "mild," "discomforting," "distressing," "horrible," and "excruciating."
Anxiety score
时间窗: 20 minutes after exposure
Measured by Dental anxiety was measured by the Modified Dental Anxiety Scale (MDAS) questionnaire
次要结局
- Blood pressure(20 minutes after exposure)
研究者
Ghada Amin Khalifa, PhD
Professor of Maxillofacial Surgery and Diagnostic Science
Qassim University