Does Massage With or Without Aromatherapy Reduce Infant's Distress After Craniofacial Surgery? A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- level of COMFORT with videotaped COMFORT behavior scale
研究概览
简要总结
This study aims to determine the effect of massage with or without aromatherapy on infant´s level of distress
详细描述
Despite extensive use of pharmacological treatments such as sedatives, distress and anxiety remain a huge problem in patients admitted to the PICU, especially in the 65% under the age of 3. Parents are anxious about the outcome and feel powerless because they have to transfer care to doctors and nurses. Those in favor of complementary care, realize at the same time that there is lack of evidence to support its use in daily practice. On the other hand, many sedatives used in infants are unlicensed and animal studies even suggest increased risk of neuroapoptosis using midazolam at an early age.
In a first study we will evaluate the effects of aromatherapy massage or massage compared to standard care in infants after craniofacial surgery.
The first group receives: aromatherapy massage using a concentration of mandarin essence in the massage oil, the second group: massage (without essential oils) and the third (control) group receives standard postoperative care. Massage will be performed in a standardized way using the ' m' technique® developed by dr. Buckle. Primary outcome is the percentage of patients with COMFORT behavior score below 17, assessed from videomaterial by a rater blinded for condition.The intervention will be carried out three hours after return from surgery.Secondary outcomes are bedside COMFORT behavior scores assessed by the caregiving nurse and the amount of midazolam used in the first 24 hours postoperative as well as the use of additional analgesics such as paracetamol and morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 3 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 6 to 36 months admitted to the Intensive Care-Sophia after craniofacial surgery
排除标准
- •Neurological impairment
- •Eczema or other skin disorders
- •Nut allergy
结局指标
主要结局
level of COMFORT with videotaped COMFORT behavior scale
时间窗: first 24 hours postoperative
次要结局
- COMFORT behavior bedside and Visual Analogue Scale distress, change in Heart Rate, change in Mean Arterial Pressure, amount of required sedatives/opioids(first 24 hours postoperative)
