Cold Application Effects on Nausea and Vomiting After Laparoscopic Cholecystectomy

Sponsor
Ankara Medipol University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06008262
Collaborator
(none)
54
1
2
5.9
9.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Cold Application
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
The Effect of Cold Application on Nausea and Vomiting After Laparoscopic Cholecystectomy
Actual Study Start Date :
Jul 3, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change from postoperative nausea degree in a 15 minutes [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.

  2. Change from postoperative vomiting in a 15 minutes [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.

  3. Evaluation of cold application effectiveness [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neslihan Ilkaz Ankara Turkey

Sponsors and Collaborators

  • Ankara Medipol University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Neslihan Ilkaz, Assistant Professor, Ankara Medipol University
ClinicalTrials.gov Identifier:
NCT06008262
Other Study ID Numbers:
  • E-81477236-604.01.01-1666
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Neslihan Ilkaz, Assistant Professor, Ankara Medipol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2023