The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery

Официальное название

The Effect of Menthol Spray and Cold Spray Applications on Postoperative Thirst Level and Comfort in Patients Undergoing Bariatric Surgery

Обзор

Bariatric surgery is a widely used surgical treatment method in obesity management that improves quality of life and provides long-term weight loss. Patients often experience thirst in the early postoperative period. Factors that increase thirst include cessation of oral intake, room temperature, intubation, dehydration, hypovolemia, and oxygen therapy in the preoperative period. Furthermore, failure to initiate oral intake early in the postoperative period increases thirst and negatively impacts patient comfort. The aim of this study is to evaluate the effects of menthol spray and cold spray applications on the thirst and comfort levels of patients in the postoperative period. The study aims to contribute to the improvement of nursing practices related to postoperative thirst and comfort management with the findings obtained from this study. This randomized controlled clinical trial is planned to be conducted with patients undergoing bariatric surgery at the General Surgery Clinic of Istanbul Atlas University Hospital. The study population will consist of patients hospitalized in the General Surgery Department of Atlas University Hospital who have undergone bariatric surgery. The sample was determined as 159 patients meeting the inclusion criteria in three groups, calculated using the GPower 3.1.9.7 program with an effect size of f=0.25, a significance level of α=0.05, and a test power of (1-β)=0.80. Considering data loss, the study is planned to be conducted with 180 patients. The "Patient Information Form," "Visual Analog Scale-Comfort (VAS-A)," "Dehydration Visual Analog Scale (VAS)," and "Surgical Dehydration Discomfort Scale (CDSBRÖ)" will be used to collect research data.

Вмешательства

• Другое Menthol Group
  Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed and recorded. To prevent bronchoaspiration, the patient's bed will be raised at a 30°-45° angle. The patient will then be instructed to open their mouth, lift their tongue, and direct the spray towards the sublingual area, the mucous membranes of both cheeks, and the
• Другое Cold Spray Group
  Cold Spray Group Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, thirst severity, and thirst-related discomfort scale. Initial assessments (irritation, nausea, vomiting, aspiration risk, swallowing difficulty) will be performed as soon as the patient arrives at the clinic after surgery. The patient's bed will be raised at a 30°-45° angle to prevent bronchoaspiration. Then, the patient will be
• Другое Placebo Group
  Patients who arrive at the clinic after surgery and participate in the study will have their comfort scores determined and recorded using the VAS scale, and their thirst severity and thirst-related discomfort scale will be assessed. Initial assessments (irritation, nausea, vomiting, aspiration risk, dysphagia) will be performed as soon as the patient arrives at the clinic post-surgery. The patient's bed will be raised to a 30°-45° angle to prevent bronchoaspiration. The patient will then be inst

Первичные конечные точки

• Postoperative thirst intensity [Срок оценки: Baseline (upon admission to the surgical ward before intervention), and at the 2nd, 4th, and 6th postoperative hours.]

Вторичные конечные точки (1)

• Postoperative comfort [Срок оценки: Baseline (before intervention), and at the 2nd, 4th, and 6th postoperative hours.]

Критерии участия

Критерии включения

• • Patients who are 18 years of age or older,

• who undergo bariatric surgery under general anesthesia,
• who do not have oral or nasal diseases, or vision, hearing, speech, or comprehension problems,
• who are classified as grade I or II according to the American Society of Anesthesiologists (ASA) Physical Status Classification System,
• who are not allergic to menthol,
• who do not have severe vomiting, and • whose preoperative fasting and thirst period is 8 hours.

Критерии исключения

• Patients with impaired oral and tongue mucosal integrity prior to surgery, Patients with any neurological, kidney, heart or lung disease with cognitive impairment and those using psychoactive drugs will be excluded.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Turkey (Türkiye) · 1 центр

• Atlas University — Istanbul

Публикации

• Lian R, Zhou S, Guo Y, Liang H, Lin J, Li D, Wu W, Rao Y, Shao D, Zheng P, Yang X. The effect of ice-cold water spray following the model for symptom management on postoperative thirst in patients admitted to intensive care unit: A randomized controlled study. Intensive Crit Care Nurs. 2024 Apr;81:103571. doi: 10.1016/j.iccn.2023.103571. Epub 2024 Jan 10. PMID 38211420

Идентификаторы

NCT: NCT07728500 · 04.05.2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗