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临床试验/NCT06008262
NCT06008262Enrolling By Invitation不适用

The Effect of Cold Application on Nausea and Vomiting After Laparoscopic Cholecystectomy

Ankara Medipol University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
54
试验地点
1
主要终点
Evaluation of cold application effectiveness

研究概览

简要总结

This clinical trial aims to test the effect of cold application on postoperative nausea and vomiting.

详细描述

Nausea and vomiting seen within the first 24 hours after surgery are defined as "Post-Operative Nausea and Vomiting (POBK). Postoperative nausea and vomiting are one of the most common complications of anesthesia. It has been reported that the risk of nausea and vomiting is particularly high after laparoscopic cholecystectomy. It is stated that vagal stimulation and pneumoperitoneum process may trigger this situation in laparoscopic surgeries. Nausea and vomiting after surgery is a very uncomfortable situation for the patient. There are several pharmacological methods to prevent and treat POBK. However, it is stated that the non-pharmacological approach should also be brought to the fore. It is stated that cold reduces molecular activity and causes vasoconstriction. It is stated that cold can slow down the blood flow to the vomiting center in the medulla oblongata and the progression of nausea and vomiting can be slowed down. In this way, it is thought that it will contribute to increasing patient satisfaction and providing cost-effective care.

The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the patients before and after the surgery, the study will conduct with various data collection forms.

These forms are; the patient data collection form, numerical evaluation scale, preoperative Apfel risk score evaluation form, postoperative nausea severity evaluation form, and perceived effectiveness of the ice pack forms will use. Laparoscopic cholecystectomy will perform and all cases meeting the inclusion criteria will evaluate. Patients will randomize. The ice pack will apply in group-I (n=27), and group II (n=27) will be the control group. An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, at an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.

In the control group, the severity of nausea and pain will be determined by using a numerical evaluation scale in patients with postoperative nausea. Vital signs will be recorded at this stage. Standard procedures will be applied to these patients within the scope of nursing practices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion in ASA (American Society of Anesthesiologists) I-II-III class
  • •Being over 18 years old
  • •Having received general anesthesia
  • •Preoperative pain value of 6 or less

排除标准

  • •Severe nausea in the preoperative period
  • •Being hypothermic in the postoperative period
  • •Having had head and neck surgery
  • •Taking prophylactic antiemetics
  • •Postoperative pain value of 7 and above

研究组 & 干预措施

Cold Application Group

Experimental

An ice pack will be applied to the posterior upper neck regions of patients with nausea in Group-I, with an interval of 5 minutes. The vital signs of the patients will be recorded. The severity of nausea and pain of the patients will be evaluated with a numerical rating scale. The effectiveness of its application as perceived by the patient will be evaluated.

干预措施: Cold Application (Other)

Control Group

No Intervention

In the control group, the severity of nausea and pain will be determined by using a numerical evaluation scale in patients with postoperative nausea. Vital signs will be recorded at this stage. Normal procedures will be applied to these patients within the scope of nursing practices.

结局指标

主要结局

Evaluation of cold application effectiveness

时间窗: Within 15 minutes of first sense of postoperative nausea

In this section, the effectiveness of cold application with a Ice Pack Perceived Effectiveness Form. In this form, there are three different expressions as the application reduced nausea, did not affect nausea, increased nausea.

Change from postoperative vomiting in a 15 minutes

时间窗: Within 15 minutes of first sense of postoperative nausea

In this section, postoperative vomiting will not occur. This status will evaluate with yes/no question.

Change from postoperative nausea degree in a 15 minutes

时间窗: Within 15 minutes of first sense of postoperative nausea

In this section, the degree of postoperative nausea will decrease or disappear. This status will evaluate with Numerical Evaluation Scale.

次要结局

未报告次要终点

研究者

发起方
Ankara Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Neslihan Ilkaz

Assistant Professor

Ankara Medipol University

研究点 (1)

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