The Effect of Aromatherapy on Anxiety and Pain for First Dental Visit Patients: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS)
研究概览
简要总结
First dental visit experience is strongly correlated with dental anxiety, the aim of this protocol is to explore the efficacy of olfactory aromatherapy for the reduce of dental anxiety and pain in first-visit patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who never visited dental clinics before;
- •Patients who need dental treatment, such as resin filling, root canal treatment, periodontal initial treatment, tooth extraction, etc;
- •Patients and their guardians who are able to understand the purpose of the study and volunteer to take part in the study;
- •Patients who are intellectually sufficient to complete the anxiety scale;
- •Be able to complete all assessments and follow-up during the study.
排除标准
- •Patients who are allergic to the ingredients of the essential oils used in the experiment or to the materials used in the dental treatment;
- •Patients who underwent only an oral examination;
- •Patients with severe heart disease, hypertension, respiratory disease, or other systemic conditions that were not eligible for trial participation;
- •Pregnant or lactating women;
- •People with depressive symptoms, anxiety disorders or other mental illnesses that affect their mood state;
- •People who are using sedative or analgesic drugs;
- •Recent or current users of essential oils;
- •Any circumstances considered by the investigator to be inappropriate for participation in this study.
结局指标
主要结局
Anxiety scale 1 - Modified Dental Anxiety Scale (MDAS)
时间窗: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.
The Modified Dental Anxiety Scale (MDAS) consists of 4 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious', hence, the total score varies from 4 to 20, with higher obtained scores describing more elevated levels of dental anxiety. MDAS is recorded before, during and after operation.
Pain scale - Visual Analog Scale (VAS)
时间窗: 5 minutes before operation/during operation (immediately after the most painful procedure)/immediately after operation.
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." VAS is recorded before, during and after operation.
次要结局
- Anxiety scale 2 - State-Trait Anxiety Inventory for State Anxiety (STAI-S)(5 minutes before operation/ immediately after operation.)
- Vital sign 1 - systolic blood pressure (SBP)(5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.)
- Vital sign 2 - diastolic blood pressure (DBP)(5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.)
- Vital sign 3 - heart rate (HR）(5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.)
- Vital sign 4 - oxygen saturation (SpO2）(5 minutes before operation/during operation (immediately after the most painful procedure, and every 10min after)/immediately after operation.)
研究者
He Cai
Post Doctor
Sichuan University