The Effect of Cold Steam Application on Nausea and Vomiting

Not Applicable

Not yet recruiting

• Conditions: Nausea and Vomiting, Postoperative

• Registration Number: NCT06760871
• Lead Sponsor: Trakya University

Brief 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.

Study Timeline

• Study First Submitted: 2024-12-17
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-01-15
• Primary Completion: 2025-04-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Undergoing abdominal surgery under general anaesthesia,
• Admitted to the general surgery ward after surgery,
• Who volunteered to participate in the research,
• No mental disability,
• 18 years of age,
• Literate,
• Accepting random selection,
• without Turkish communication problems,
• No preoperative oncological treatment,
• undergoing elective surgery,
• Postoperatively without a nasogastric catheter,
• with an operation time <4 hours,
• Laparoscopic surgery performed,
• No postoperative nausea and vomiting or mild/moderate nausea,
• Patients with ASA score 1, 2 or 3 were determined as inclusion criteria.

Exclusion Criteria

• Severe nausea or active vomiting prior to administration,
• Migraine, vertigo, etc. who may experience nausea and vomiting due to vestibular disease, pregnancy,
• COPD, asthma, etc. with respiratory problems,
• Not accepting the application of cold steam,
• Not accepting random selection,
• Those with a history of chemotherapy or radiotherapy before surgery,
• Patients who underwent sudden movement changes (bed change, patient transfer, etc.) during the data collection period (0 to 2nd hour),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
nausea rate	6 months	Nausea rate (%)

Secondary Outcome Measures

Name	Time	Method
Antiemetic requirement	6 months	Antiemetic requirement (Yes/No)

Trial Locations

Locations (1)

Trakya University Hospital; 🇹🇷 Edirne, Turkey