Effect of Aromatherapy on Preoperative Anxiety Level
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Anxiety level
研究概览
简要总结
The aim of the study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia.
This was a prospective double blinded randomized controlled trial. After patient's approval, the anxiety level was assessed preoperativetively with Visual Analogue scale-anxiety and APAIS scale. To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil. After randomisation and allocation, the investigators prooceeded with the intervention preoperatively. In the operating room, the acte under spinal anethesia was performed. Then we collect data postoperatively.
详细描述
Preoperative anxiety is a common occurrence that has the potential to be harmful, with prevalence rates in the literature ranging from 27% to 80%. Clinical manifestation ranges from malaise to acute stress disorder that meets the criteria of Diagnostic and Statistical Manual of Mental Disorders 5 (DSM5).It is associated with a rise of peri-operative morbidity and mortality. Anti-anxiety medications may be effective but it comes with a number of undesirable adverse effects. Aromatherapy is a non-pharmacological approach that is alluring, affordable, and inexpensive and has minimal side effects, but there aren't enough studies to support its efficacy.
The aim of our study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia.
This was a prospective double blinded randomized controlled trial The patients were seen the night before the surgery, a pre-anesthetic visit was performed.
To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil.
Surgery day, one hour before operation, vital signs were taken: Heart rate, respiratory rate, pulse oximetry, systolic arterial pressure and diastolic arterial pressure.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sequentially numbered and sealed opaque envelopes method was used to carry out the randomization and allocation.
These were done by a different doctor from the one caring for the patient in the peri-operative period.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgery under spinal anesthesia: continuous or single shot;
- •Conscious patient cooperative able to communicate;
- •No preoperative cognitive disorder;
- •Patient consent;
- •American society of anesthesiologists' (ASA) physical status of I-III
排除标准
- •Pregnant or breastfeeding women;
- •Chronic obstructive pulmonary disease;
- •Allergic to essentials oils;
- •History of chronic anxiety or depression;
- •Neuropsychiatric disorder;
- •Use of anti-anxiety medications or anti-depressants;
- •Drug addiction;
- •Emergency surgery required immediately or within 6 hours.
研究组 & 干预措施
Group C
patients receiving aromatherapy using cotton balls impregnated with 3 drops of lavender essential oil inhaled from a distance of 10 cm during 20 minutes and pure oxygen administered through a face mask.
干预措施: lavender essential oil inhaled using cotton balls (Drug)
Group M
- Group M: inhaled three drops of lavender oil through a facemask. These three drops were already diluted by five milliliters of distilled water and were sprayed in the area by a nebulizer. A cotton ball soaked with water was put 10 cm next to the patient.
干预措施: lavender essential oil inhaled using face mask (Drug)
Group P
Placebo group: inhaled five milliliters of distilled water in the same way as the patients in the experimental group and also cotton balls with 3 drops of water are placed near the patient.
干预措施: Distilled water (Drug)
结局指标
主要结局
Anxiety level
时间窗: before and 30 minutes after the intervention 2 hours befor surgery
Visual Analogue Scale (minimum value 0 means no anxiety and maximum value 10 means the highest anxiety level)
次要结局
- Pre-operative anxiety and information scale(before and 30 minutes after the intervention 2 hours befor surgery)
- Anti-anxiety medications requirement(Fifteen minutes before spinal anesthesia or during the act)
- Patient satisfaction(2 hours after the end of the surgery)
研究者
Mhamed Sami Mebazaa
Professor
Mongi Slim Hospital