Evaluation of the Efficacy of an Aromatherapy Treatment With Lavender Essential Oil to Reduce Post-Operative Nausea and Vomiting (PONV): Two-arm, Non-pharmacological, Single-centre, Non-profit, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To evaluate the effectiveness of administering Lavender Angustifolia essential oil by inhalation in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of aromatherapy through the use of inhaled Lavender oil in reducing patients' nausea during the post-operative period.
详细描述
To evaluate the effectiveness of inhaling Lavender Angustifolia essential oil in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period.
Secondary objective
- To detect the number of antiemetic administrations in the experimental arm compared to the control arm
- To measure the patient satisfaction of patients in the experimental group with the Lavender essential oil aromatherapy intervention at hospital discharge Primary endpoint Reduction of nausea by at least 10% compared to treatment with standard care, as assessed by the NRS (Numerical Rating Scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Patients who sign an informed consent
- •Patients who have undergone anesthesiological examination
- •Patients undergoing general anaesthesia
- •Clinically stable patients
- •Patients with nausea scores detected with NRS>0
- •Patients admitted undergoing surgery in the Complex and/or Simple Structures listed below:
- •SC of Neurosurgery, undergoing spinal surgery
- •SC of General Surgery, undergoing surgery on one of the organs of the abdominal cavity
- •SC of Vascular Surgery, undergoing traditional surgical repair or endovascular procedure of abdominal aortic aneurysm. Sclerotherapy (to heal varicose veins) venous stripping (removal of a vein segment in the treatment of varicose veins) laser treatment
- •SS of Gynaecological Surgery, undergoing operations on the organs of the female genital apparatus.
排除标准
- •Patients with ongoing relevant cognitive impairment (Six Item Screener score <4)
- •Patients with allergies or sensitivities to lavender essential oils
- •Patients with asthma, COPD, Chronic Bronchitis, Obstructive Sleep Apnea
- •Patients with changes in sense of smell
研究组 & 干预措施
Lavender Yes
The lavender essential oil may only be used at the first episode of nausea occurring within 24 hours post-surgery; during the same period, if nausea occurs again, it will be treated as per standard care
干预措施: Lavanda Angustifolia essential oil (Other)
Usual Care
Standard procedure, which consists of administering antiemetics if provided in therapy or reporting to the physician with a subsequent treatment decision
干预措施: Usual Care (Other)
结局指标
主要结局
To evaluate the effectiveness of administering Lavender Angustifolia essential oil by inhalation in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period
时间窗: during the 24-hour post-operative period
To reduce nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period. Endpoint Reduction of nausea by at least 10% compared to treatment with standard care, as assessed by the NRS (Numerical Rating Scale).
次要结局
- To evaluate the effectiveness of administering Lavender Angustifolia essential oil by inhalation in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period(during the 24-hour postoperative period)
- o evaluate the effectiveness of administering Lavender Angustifolia essential oil by inhalation in reducing nausea after abdominal, vascular, neurosurgical and gynaecological surgery under general anaesthesia during the 24-hour postoperative period(during the 24-hour postoperative period)