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

Zonguldak Bulent Ecevit University

Status: Enrolling

Conditions: Local Application/Packing Too Cold; Patient Satisfaction; Postoperative Nausea and Vomiting

Treatments: Other: Cold application

Study type: Interventional

Funder types: Other

Identifiers

NCT05888818

2022/16-08

Details and patient eligibility

About

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.

Full 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.

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

cold application group

Experimental group

Description:

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

Treatment:

Other: Cold application

standard treatment

No Intervention group

Description:

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