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临床试验/NCT07728500
NCT07728500尚未招募不适用

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

Atlas University1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
Postoperative thirst intensity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • 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.

排除标准

  • 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.

结局指标

主要结局

Postoperative thirst intensity

时间窗: Baseline (upon admission to the surgical ward before intervention), and at the 2nd, 4th, and 6th postoperative hours.

Postoperative thirst intensity will be assessed using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no thirst) to 10 (worst possible thirst).

次要结局

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

研究者

发起方
Atlas University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cagla Toprak

Dr.

Atlas University

研究点 (1)

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