冷蒸汽对恶心和呕吐的影响
冷蒸汽应用对腹腔镜腹部手术后恶心和呕吐的影响：随机对照试验
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.
研究概览
详细说明
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.
研究类型
阶段
- 不适用
联系人和位置
学习地点
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-
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Edirne、土耳其（türkiye）
- Trakya University Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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),
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Experimental group
Patients in the experimental group will receive inhaled cold vapour. |
After the surgery, the patients will be admitted to the ward and taken to the bed, and their care and treatment will be applied by the nurse. Afterwards, the researcher will apply cold vapour as an inhaler for 15 minutes. For this application, the stand to which the ultrasonic nebuliser device is connected will be positioned close to the patient's bed. 200 ml of distilled water will be placed in the liquid reservoir of the device. The patient will be given a comfortable position and the device will be adjusted so that the steam hose covers the patient's mouth and nose and the patient will be allowed to inhale the steam through the mouth and nose. After the electrical connection of the device is provided, the device will be started and cold steam application will begin. In the 1st hour, inhaler cold water vapour application will be performed for 15 minutes. |
|
无干预：Control group
Patients in the control group will not be intervened within the scope of the study. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
nausea rate
大体时间：6 months
|
Nausea rate (%) |
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Antiemetic requirement
大体时间：6 months
|
Antiemetic requirement (Yes/No) |
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.