Efficacy of Lavender Essential Oil Chest Wraps in Improving Cough and Respiratory Distress in Infants With Bronchiolitis: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Cough frequency
研究概览
简要总结
The goal of this clinical trial is to learn if lavender essential oil chest wraps relieve cough in infants with bronchiolitis compared to standard care. Furthermore, the researchers will evaluate if breathing difficulties, nighttime awakening and impact on parents will be improved by the lavender oil chest wraps. Infants will be randomized to receive standard care with the addition of lavender oil chest wraps or to receive standard care alone. The study will take place in two locations in Switzerland, at the Geneva University Hospital and the Fribourg Cantonal Hospital.
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
- — 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lavender oil
Lavender chest wrap:
Before the first application pour 10-15 ml of lavender essential oil 10% evenly on the cotton cloth. Put the soaked cotton in the plastic bag, close it and put it to heat in two heating pads (2-5 minutes) so that the oil is distributed on all the fabric. Place the cotton cloth around the patient's chest. Cover the cotton cloth with a woolen fabric that is 2 cm larger than the cotton cloth.
干预措施: Lavender essential oil 10%, diluted in 90% olive oil (Drug)
Control
Standard care: supportive measures according to national standards.
干预措施: Control (Other)
结局指标
主要结局
Cough frequency
时间窗: Up to 2 days
Number of coughs per hour measured with Hyfe CoughMonitor (Hyfe Inc)
次要结局
- Oxygen supplementation duration(Immediately at discharge from hospital)
- Crying episodes(Up to 2 days)
- Hospital length of stay(Immediately at discharge from hospital)
- Oxygen supplementation requirement(Immediately at discharge from hospital)
- Parental satisfaction assessed with patient satisfaction questionnaire(Immediately at discharge from hospital)
- Respiratory rate(Baseline, 1 hour, 4 hours)
- Maximum oxygen supplementation(Immediately at discharge from hospital)
- Impact on parents assessed by the "Impact of Bronchiolitis Hospitalization Questionnaire" (IBHQ)(Immediately at discharge from hospital)
研究者
Fabiola Stollar
Attending Physician
University Hospital, Geneva