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NCT Number: NCT06760871

The Effect of Cold Steam Application on Nausea and Vomiting

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.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

nebulised distilled water

Other

After 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.

Primary outcomes

  1. nausea rate

    Time frame: 6 months

    Nausea rate (%)

Secondary outcomes

  1. Antiemetic requirement

    Time frame: 6 months

    Antiemetic requirement (Yes/No)

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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