Effect of Peppermint Aroma on Physiological Parameters of Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
Three drops of peppermint oil will be dropped on a cotton ball that will be fixed in the patient's collar. In the placebo group, peppermint oil will be replaced with water.
详细描述
Mechanical ventilathetion increases the anxiety of critically ill patients. The physiological parameters of those patients are affected by stress. Peppermint inhalation reduces stress and improves physiological parameters in many studies, but none of these studies used peppermint inhalation on mechanically ventilated patients.
Patients who are conscious on mechanical ventilation via endotracheal via tube will be randomly assigned to two groups. Patients will be kept intubated and mechanically ventilated. Nothing will be changed in patients' mechanical ventilation data. The intervention group will receive peppermint inhalation intervention, and the placebo group received water inhalation intervention. Patients in both groups will be assessed for their smell ability by Sniffin Sticks-test before starting the interventions.
Three drops of undiluted peppermint oil will be dropped on a cotton ball. Then it will be placed about 20 cm from the patient's nose. It will be fixed on the patient's collar. In the placebo group, the cotton ball will be soaked in water. Then, patients will be monitored for one hour.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with
- •(1) endotracheal tube (ETT)
- •(2) mechanical ventilation with spontaneous breathing modes which are CPAP, PIPAP and PSV
- •(3) FOUR score equal to or more than 13,
- •(4) RASS score from -1 to +4.
排除标准
- •Patients with
- •(1) respiratory asthma
- •(2) chronic obstructive pulmonary disease
- •(3) acute respiratory distress syndrome,
- •Sniffin' Sticks-test score of smell less than 17
研究组 & 干预措施
Peppermint group
This group will receive peppermint oil aroma
干预措施: Aromatherapy (Other)
Water group
This group will receive water as an aroma oil
干预措施: Placebo (Other)
结局指标
主要结局
Heart rate
时间窗: Change from baseline heart rate at one hour.
The number of heart beats in one minute. It will be reported in beat per minute.
Respiratory rate
时间窗: Change from baseline respiratory rate at one hour.
The number of breaths in one minute. It will be reported in breath per minute.
Mean blood pressure
时间窗: Change from baseline mean blood pressure at one hour.
Mean blood pressure equal diastolic blood pressure + 1/3 \[systolic blood pressure - diastolic blood pressure\]. It will be reported in millimeters of mercury (mmHg).
Pain score
时间窗: Change from baseline pain score at one hour.
It will be measured using non verbal pain assessment scale. It consists of five categories; face, movement, guarding, physiology, and respiratory items. It will be reported in score. The maximum score of the scale is 10 which means extremely sever pain, and the minimum score is zero which means no pain.
次要结局
未报告次要终点