Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy

August 22, 2023 updated by: Neslihan Ilkaz, Ankara Medipol University

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Neslihan Ilkaz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cold Application Group
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
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.
No Intervention: Control Group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from postoperative nausea degree in a 15 minutes
Time Frame: 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.
Within 15 minutes of first sense of postoperative nausea
Change from postoperative vomiting in a 15 minutes
Time Frame: 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.
Within 15 minutes of first sense of postoperative nausea
Evaluation of cold application effectiveness
Time Frame: 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.
Within 15 minutes of first sense of postoperative nausea

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Medipol University

Investigators

  • Principal Investigator: Neslihan Ilkaz, PhD, Ankara Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-81477236-604.01.01-1666

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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