The Effect of Cold Application on Nausea and Vomiting in the Early Postoperative Period
NCT ID: NCT05888818
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-10-01
2024-10-30
Brief Summary
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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.
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Detailed Description
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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.
1. 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.
2. 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.
3. 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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cold application group
A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.
Cold application
A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.
standard treatment
No application will be made and the presence of nausea, severity, vomiting and vital signs will be measured after 5 minutes.
No interventions assigned to this group
Interventions
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Cold application
A cold application (with a cold gel pack) will be applied to the upper part of the neck for 5 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients who do not volunteer to participate in the study will not be included in the study.
Exclusion Criteria
* 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,
18 Years
65 Years
ALL
Yes
Sponsors
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Zonguldak Bulent Ecevit University
OTHER
Responsible Party
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Nigar Ak Turkis
Doctoral Candidate in Surgical Nursing Science
Principal Investigators
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Nigar AK TURKİS, PhD student
Role: PRINCIPAL_INVESTIGATOR
Zonguldak Bulent Ecevit University,PhD student
Locations
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Zonguldak Bulent Ecevit University
Zonguldak, Kozlu, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022/16-08
Identifier Type: -
Identifier Source: org_study_id
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