Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy

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

Detailed Description
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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.

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

Conditions
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Laparoscopic Cholecystectomy, Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: Cold Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Application Group<br>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. | Other: Cold Application<br>* 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.<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from postoperative nausea degree in a 15 minutes | In this section, the degree of postoperative nausea will decrease or disappear. This status will evaluate with Numerical Evaluation Scale. | Within 15 minutes of first sense of postoperative nausea | 
| Change from postoperative vomiting in a 15 minutes | In this section, postoperative vomiting will not occur. This status will evaluate with yes/no question. | Within 15 minutes of first sense of postoperative nausea | 
| Evaluation of cold application effectiveness | 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. | Within 15 minutes of first sense of postoperative nausea | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic cholecystectomy, Postoperative Nausea and Vomiting, Cold application