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Not Yet RecruitingNCT06760871

The Effect of Cold Steam Application on Nausea and Vomiting

The Effect of Cold Steam Application on Nausea and Vomiting After Laparoscopic Abdominal Surgery: Randomized Controlled Trial

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
88 (estimated)
Sponsor
Trakya University · Academic / Other
Sex
All
Age
18 Years – 110 Years
Healthy volunteers
Not accepted

Summary

The aim of this study was to determine the effect of cold vapour applied to patients undergoing laparoscopic abdominal surgery primarily on nausea and vomiting and secondarily on antiemetic requirement, patient satisfaction and thirst. H1: Cold steam application after surgical intervention has a decreasing effect on postoperative nausea. H2: Cold steam application after surgical intervention has a decreasing effect on postoperative vomiting. H3: Cold steam application after surgical intervention reduces the need for antiemetic drugs. H4: Cold steam application after surgical intervention has a satisfactory effect on reducing nausea and vomiting.

Detailed description

The research will be conducted with the participation of surgical patients who underwent laporoscopic abdominal surgery between December 2024 and March 2025 in the General Surgery Department of Trakya University Hospital. Effect size of 0.2 was predicted, the smallest possible significant correlation coefficient between repeated measurements was accepted as 0.3, and the minimum number of people to be included in the sample was calculated as 80, consisting of 40 patients from each group with a 95% confidence level, 5% margin of error and 80% power value. In case of possible data loss, drop out rate was accepted as 10% and 44 patients were included in each group.

Conditions

Interventions

TypeNameDescription
OTHERnebulised distilled waterAfter the surgery, the patients will be admitted to the ward and taken to the bed, and their care and treatment will be applied by the nurse. Afterwards, the researcher will apply cold vapour as an inhaler for 15 minutes. For this application, the stand to which the ultrasonic nebuliser device is connected will be positioned close to the patient's bed. 200 ml of distilled water will be placed in the liquid reservoir of the device. The patient will be given a comfortable position and the device will be adjusted so that the steam hose covers the patient's mouth and nose and the patient will be allowed to inhale the steam through the mouth and nose. After the electrical connection of the device is provided, the device will be started and cold steam application will begin. In the 1st hour, inhaler cold water vapour application will be performed for 15 minutes.

Timeline

Start date
2025-01-15
Primary completion
2025-04-15
Completion
2025-12-30
First posted
2025-01-07
Last updated
2025-01-07

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06760871. Inclusion in this directory is not an endorsement.