Aromatherapy and Peri Operative Anxiety : Assessment in Ambulatory Elective Upper Limb Surgery Under Loco-regional Anesthesia, a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 289
- 试验地点
- 2
- 主要终点
- Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation
研究概览
简要总结
AROMA study is a randomised controlled parallel-group single-site study. Patients randomized in the experimental group benefit from the aromatherapy at their arrival in the operating theatre in the recovery room. 2 drops of essential oils are applied on a compress placed next to the head of the patient. This compress is kept until the patient is leaving the operating theatre. Patients randomized in the control group don't benefit from the aromatherapy. The anxiety evolution is measured in both groups with the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The hypothesis is that aromatherapy alleviate peri operative anxiety during an ambulatory elective upper limb surgery under loco-regional anesthesia.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient admitted in Hospital Centre for an ambulatory elective upper limb " fast track " surgery
- •Patient with loco-regional anesthesia
- •Patient categorized 3 or less according to the American Society of Anesthesiologists (ASA) score
- •The patient must have given his written consent to participate in the study
- •Patient - insured under the French social security system
- •Patient prepared to comply with all the terms of the study and its length
排除标准
- •Epileptic patients
- •Asthmatic patients
- •Patients with cognitive disorders ( Mini Mental Status below 15)
- •Psychiatric disorders : current depression or bipolar disease or anxiety disorders or psychotic disorders according to DSM-V classification
- •American Society of Anesthesiologists score strictly superior to 3
- •Preoperative chronic pain : neuropathic pain, fibromyalgia, polyarthritis
- •Pregnant or breastfeeding woman
- •Patient unable to receive an informed consent and to comply with all the terms of the study
- •Patient without any social insurance
- •Refusal to sign the consent
- •Patient under legal protection
- •Patient in emergency (unstable clinical state)
- •Patient unable to read or write french
- •Patient enrolled in an other clinical trial
研究组 & 干预措施
aromatherapy group
The patient has to choose an essential oil among the 3 proposed :
- sweet orange (Citrus sinensis L. Persoon)
- fine lavender (Lavandula angustifolia P. Miller)
- little seed from the mandarin tree (Citrus reticulata blanco)
干预措施: Olfactory aromatherapy (Other)
without aromatherapy
干预措施: without aromatherapy (Other)
结局指标
主要结局
Amsterdam Preoperative Anxiety and Information Scale (APAIS) score variation
时间窗: Between time T0 (arrival in the operating room in the recovery room) and time T1 (10 minutes after T0, before loco-regional anesthesia), an average 10 minutes
次要结局
- Anxiety Visual Analogic Scale change after the arrival in the operating room(at baseline and an average at 10 minutes,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room)
- Satisfaction Visual analogic Scale change after the arrival in the operating theater.(at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room)
- Percentage of patients needing a perioperative drug-induced sedation.(at baseline and an average ,at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room)
- Comfort Visual analogic Scale variation change after the arrival in the operating theater.(at baseline and an average at 35 minutes, at 70 minutes and at 3 hours after arriving in operating room)