Clinical trial NCT06760871: The Effect of Cold Steam Application on Nausea and Vomiting
Official title: The Effect of Cold Steam Application on Nausea and Vomiting After Laparoscopic Abdominal Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nausea and Vomiting, Postoperative
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients in the experimental group will receive inhaled cold vapour. Patients in the control group will not be intervened within the scope of the study.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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),

Primary outcomes:
measure: nausea rate
timeFrame: 6 months
Secondary outcomes:
measure: Antiemetic requirement
timeFrame: 6 months
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Hospital
Study officials:
References: