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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Medipol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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