The Effect of Cold Steam Application on Nausea and Vomiting After Laparoscopic Abdominal Surgery: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- nausea rate
研究概览
简要总结
The aim of this study was to determine the effect of cold vapour applied to patients undergoing laparoscopic abdominal surgery primarily on nausea and vomiting and secondarily on antiemetic requirement, patient satisfaction and thirst.
H1: Cold steam application after surgical intervention has a decreasing effect on postoperative nausea.
H2: Cold steam application after surgical intervention has a decreasing effect on postoperative vomiting.
H3: Cold steam application after surgical intervention reduces the need for antiemetic drugs.
H4: Cold steam application after surgical intervention has a satisfactory effect on reducing nausea and vomiting.
详细描述
The research will be conducted with the participation of surgical patients who underwent laporoscopic abdominal surgery between December 2024 and March 2025 in the General Surgery Department of Trakya University Hospital.
Effect size of 0.2 was predicted, the smallest possible significant correlation coefficient between repeated measurements was accepted as 0.3, and the minimum number of people to be included in the sample was calculated as 80, consisting of 40 patients from each group with a 95% confidence level, 5% margin of error and 80% power value. In case of possible data loss, drop out rate was accepted as 10% and 44 patients were included in each group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing abdominal surgery under general anaesthesia,
- •Admitted to the general surgery ward after surgery,
- •Who volunteered to participate in the research,
- •No mental disability,
- •18 years of age,
- •Literate,
- •Accepting random selection,
- •without Turkish communication problems,
- •No preoperative oncological treatment,
- •undergoing elective surgery,
- •Postoperatively without a nasogastric catheter,
- •with an operation time <4 hours,
- •Laparoscopic surgery performed,
- •No postoperative nausea and vomiting or mild/moderate nausea,
- •Patients with ASA score 1, 2 or 3 were determined as inclusion criteria.
排除标准
- •Severe nausea or active vomiting prior to administration,
- •Migraine, vertigo, etc. who may experience nausea and vomiting due to vestibular disease, pregnancy,
- •COPD, asthma, etc. with respiratory problems,
- •Not accepting the application of cold steam,
- •Not accepting random selection,
- •Those with a history of chemotherapy or radiotherapy before surgery,
- •Patients who underwent sudden movement changes (bed change, patient transfer, etc.) during the data collection period (0 to 2nd hour),
研究组 & 干预措施
Experimental group
Patients in the experimental group will receive inhaled cold vapour.
干预措施: nebulised distilled water (Other)
Control group
Patients in the control group will not be intervened within the scope of the study.
结局指标
主要结局
nausea rate
时间窗: 6 months
Nausea rate (%)
次要结局
- Antiemetic requirement(6 months)
研究者
Zeynep Kızılcık Ozkan
associate professor
Trakya University