The Effect of Cold Steam Application on Nausea and Vomiting

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое nebulised distilled water
  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 w

Первичные конечные точки

• nausea rate [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Antiemetic requirement [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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),

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Trakya University Hospital — Edirne

Идентификаторы

NCT: NCT06760871 · 358/2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗