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The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period

Primary Purpose

Local Application/Packing Too Cold, Patient Satisfaction, Postoperative Nausea and Vomiting

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cold application
Sponsored by
Zonguldak Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Local Application/Packing Too Cold focused on measuring Nausea and vomiting after surgery,cold application methods,nursing care after surgery,alternative and complementary methods,postoperative care,cholecystectomy, Patient satisfaction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Those who will undergo elective surgery Attempting laparoscopic cholecystectomy Those between the ages of 18-65 Those who will receive general anesthesia Not allergic to cold Body temperature ≥36°C ASA I and ASA II class Those with an Apfel risk score of 2 and above Postoperative nausea severity of 2 and above Without chronic disease Neurological problems No problem communicating,• No hearing and vision problems Being conscious, awake and oriented after surgery, Patients who volunteer to participate in the study will be included in the study Exclusion Criteria: Those who are allergic to cold Body temperature <36°C, Those who have a disability, incision and surgical procedure around the head and neck Having chronic illness Having neurological problems Having nasogastric tube Postoperatively conscious, awake and not oriented, Not eligible for inclusion criteria and Patients who do not volunteer to participate in the study will not be included in the study.

Sites / Locations

  • Zonguldak Bulent Ecevit UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cold application group

standard treatment

Arm Description

A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.

No application will be made and the presence of nausea, severity, vomiting and vital signs will be measured after 5 minutes.

Outcomes

Primary Outcome Measures

Determining the mean scores of the experimental and control groups from the nausea numerical scale
Nausea Numerical Scale There are numbers from 0 to 10 on the scale.The scale is explained to the patients and asked to choose the number between 0 and 10 that best reflects their nausea. Zero usually indicates 'no nausea' while 10 represents 'unbearable nausea'. Evaluation will be made in the recovery room after the surgery, then at the 2nd and 6th hours.
Determination of patient satisfaction of the experimental and control groups
The patient satisfaction scale is used to evaluate patient satisfaction.It consists of numbers between "0" and "10" to determine the satisfaction level of the patients after the A value of zero indicates "no satisfaction" with the practice, while a value of ten indicates "a lot of satisfaction". Satisfaction scale will be evaluated at the 6th hour after the surgery.
Antiemetic use status of the groups
The patients' use of antiemetics after surgery will be questioned.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2023
Last Updated
May 24, 2023
Sponsor
Zonguldak Bulent Ecevit University
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1. Study Identification

Unique Protocol Identification Number
NCT05888818
Brief Title
The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period
Official Title
The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period - Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zonguldak Bulent Ecevit University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
As a result of the literature review, it has been seen that it has not yet been clarified whether cold application methods are effective on postoperative nausea and vomiting, and academic studies on this subject are needed. The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period. The research hypotheses are as follows: H1:Cold application method reduces nausea and vomiting in the early postoperative period. H1:The cold application method reduces the need for antiemetic drugs in the early postoperative period. H1:Cold application method in the early postoperative period increases patient satisfaction. Condition or disease: Postoperative nausea and vomiting,Postoperative antiemetic use status,Patient satisfaction,Effects of cold application method Intervention/treatment: There is an intervention group in which the cold application method is applied.
Detailed Description
The aim of the planned study was to conduct a randomized controlled experimental study to evaluate the effect of the cold application method on nausea and vomiting and the need for antiemetic drugs in the early postoperative period. The population of the study will consist of patients who are planned to undergo laparoscopic cholecystectomy under general anesthesia in the Department of General Surgery, Zonguldak Bülent Ecevit University Health Practice and Research Center between October 2022 and October 2024.Çalışmanın örneklemini laparoskopik kolesistektomi planlanan, dahil edilme kriterlerini karşılayan ve çalışmaya katılmaya gönüllü olan hastalar oluşturacaktır. As a result of the GPower power analysis, it was calculated that at least 60 people (at least 30 people for each group) who met the inclusion criteria of the research should be taken in order to obtain 80% power at the 95% confidence interval for the d=0.8 effect size. Data collecting: The collection of research data will be carried out in three stages. stage:Patients scheduled for laparoscopic cholecystectomy who have undergone hospitalization will be evaluated in terms of their eligibility for inclusion criteria, and eligible patients will be invited to participate in the study.The purpose of the research will be explained to the patients, the informed consent form will be read, written and verbal consent will be obtained and a copy of the form will be given to the patients.Then, the patient information data collection form and Apfel risk score will be filled with face-to-face interview technique, and the answers given by the patients will be recorded. stage: The surgery will be held in the recovery room.While the patients in the intervention group are in the recovery room after the surgery, their routine applications will be made and the state of consciousness and alertness will be checked.After the application, the presence of nausea, severity, vomiting status, vital signs (blood pressure, pulse, respiratory rate, body temperature) will be measured.Then, a cold application (with a cold gel pack) will be applied to the nape area for 5 minutes.Presence of nausea, severity, vomiting status, vital signs will be re-measured immediately after the application.Antiemetic drug use and opioid drug use will be questioned. stage:Presence, severity and presence of nausea will be re-evaluated at the 2nd and 6th hours of the experimental and control group patients.Antiemetic drug use and opioid drug use will be questioned.Patient satisfaction will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Local Application/Packing Too Cold, Patient Satisfaction, Postoperative Nausea and Vomiting
Keywords
Nausea and vomiting after surgery,cold application methods,nursing care after surgery,alternative and complementary methods,postoperative care,cholecystectomy, Patient satisfaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There is an experimental and a control group.The distribution of the patients to the groups was made according to the random numbers table obtained by using the index formulas and randomly in the excel program in the web environment.
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cold application group
Arm Type
Experimental
Arm Description
A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.
Arm Title
standard treatment
Arm Type
No Intervention
Arm Description
No application will be made and the presence of nausea, severity, vomiting and vital signs will be measured after 5 minutes.
Intervention Type
Other
Intervention Name(s)
Cold application
Intervention Description
A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.
Primary Outcome Measure Information:
Title
Determining the mean scores of the experimental and control groups from the nausea numerical scale
Description
Nausea Numerical Scale There are numbers from 0 to 10 on the scale.The scale is explained to the patients and asked to choose the number between 0 and 10 that best reflects their nausea. Zero usually indicates 'no nausea' while 10 represents 'unbearable nausea'. Evaluation will be made in the recovery room after the surgery, then at the 2nd and 6th hours.
Time Frame
two year
Title
Determination of patient satisfaction of the experimental and control groups
Description
The patient satisfaction scale is used to evaluate patient satisfaction.It consists of numbers between "0" and "10" to determine the satisfaction level of the patients after the A value of zero indicates "no satisfaction" with the practice, while a value of ten indicates "a lot of satisfaction". Satisfaction scale will be evaluated at the 6th hour after the surgery.
Time Frame
two year
Title
Antiemetic use status of the groups
Description
The patients' use of antiemetics after surgery will be questioned.
Time Frame
two year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Those who will undergo elective surgery Attempting laparoscopic cholecystectomy Those between the ages of 18-65 Those who will receive general anesthesia Not allergic to cold Body temperature ≥36°C ASA I and ASA II class Those with an Apfel risk score of 2 and above Postoperative nausea severity of 2 and above Without chronic disease Neurological problems No problem communicating,• No hearing and vision problems Being conscious, awake and oriented after surgery, Patients who volunteer to participate in the study will be included in the study Exclusion Criteria: Those who are allergic to cold Body temperature <36°C, Those who have a disability, incision and surgical procedure around the head and neck Having chronic illness Having neurological problems Having nasogastric tube Postoperatively conscious, awake and not oriented, Not eligible for inclusion criteria and Patients who do not volunteer to participate in the study will not be included in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nigar AK TURKİS, PhD student
Phone
+905066926811
Email
niiggaar_78@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nurten TASDEMİR, associate professor
Phone
+905072344018
Email
ntasdemir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigar AK TURKİS, PhD student
Organizational Affiliation
Zonguldak Bulent Ecevit University,PhD student
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zonguldak Bulent Ecevit University
City
Zonguldak
State/Province
Kozlu
ZIP/Postal Code
67100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nigar AK TURKİS, PhD student
Phone
+905066926811
Email
niiggaar_78@hotmail.com
First Name & Middle Initial & Last Name & Degree
Nurten TASDEMİR, associate professor
Phone
+905072344018
Email
ntasdemir@gmail.com
First Name & Middle Initial & Last Name & Degree
Nigar AK TURKİS, PhD student

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period

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