Effectiveness of Inhalation Aromatherapy In Children With Burns: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- body temperature
研究概览
简要总结
The study was carried out in the Pediatric Burn Unit, aged between 2 months and 7 years, with no chronic pain, second degree superficial scald burns, hydrotherapy application, no burn surgery, no pathogen growth in the burn site, the burn had not undergone epithelialization. Children receiving routine analgesic therapy were included.
Lavender oil 15 minutes, Lavender oil 60 minutes and Jojoba oil 15 minutes (Placebo group) were studied with a total of 108 children in three groups.
The children included in the study were randomized. One of the researchers measured the pain and vital signs of children before the application. 0.5 cc of aromatherapy oil, which was dripped into the gauze 15 or 60 minutes before the start of hydrotherapy and dressing, was placed 20 cm away from the child's nose. The child who inhaled the smell was hydrotherapy and dressing and then taken to bed. The other investigator, who did not know how long the child inhaled in the morning, evaluated pain and vital signs 1 and 30 minutes after the child returned to bed.
详细描述
This randomized clinical trial research experimental design was performed with pediatric burn patients on May 2018-May 2019. Routine treatment of any child was not interfered with during the data collection phase of the study.
Sample
The minimum sample size in each intervention and control group was considered 36 using G power formula with a = 0.05, power of 80%, 95% confidence interval (Gpower 3.1.9.2., Germany). Allocation to the groups was performed using the Stratified Randomization. The absence of differences in age, vital signs and pain levels between groups prior to the intervention was achieved using Stratified Randomization method.
Intervention Protocols
In the clinic where the study was conducted, all children are routinely given hydrotherapy treatment for the examination of the burn area as of 10 am every morning and then dressings are applied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 2 months-7 years,
- •having a second degree of superficial burn,
- •willing to participate in the study,
- •receiving hydrotherapy application (wet dressing),
- •dressing the child with the same dressing material,
- •having no chronic pain,
- •having scalding burn,
- •having no surgery record to treat burns,
- •having no pathogen reproduction at the burn area,
- •having no stage of epitheliazation,
- •having analgesic therapy containing the same active substance.
排除标准
- 未提供
结局指标
主要结局
body temperature
时间窗: 1 day
The body temperature of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
FLACC Pain Scale Scores
时间窗: 1 day
The FLACC Pain Scale scores of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing. FLACC (The Face, Legs, Activity, Cry, Consolability Scale) Pain Scale used by Merkel et al in 1997 in children between 2 months-7 years of age. With this scale, five behavioral criteria such as facial expression, the position of legs, movements, crying and comforting are evaluated. Each episode is rated 0-2 with scores ranging from 0-10 in total, the lower the score, the less pain is said .0 points:" no pain "1-3 points:" there is little pain "4-6 points:" there is moderate pain " 7-10 points:" there is much pain".
mean arterial pressure
时间窗: 1 day
The mean arterial pressure of the child was evaluated and recorded before dressing, also 1 and 30 minutes after the dressing.
respiratory rate
时间窗: 1 day
The respiratory rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
heart rate
时间窗: 1 day
The heart rate of the child was evaluated and recorded before dressing, also 1 minute and 30 minutes after the dressing.
次要结局
未报告次要终点
研究者
ESRA ARDAHAN AKGUL
Research Assistant
Izmir Katip Celebi University