跳至主要内容
临床试验/NCT03236623
NCT03236623Unknown不适用

The Use of the Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period: a Randomized Clinical Trial

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Intensity of thirst

研究概览

简要总结

Thirst is defined as the desire to drink water. The perception and satiation of thirst constitute an interconnected network of neuronal, physiological and hormonal mechanisms that act simultaneously. In the oropharyngeal cavity are ionic channels called Transient Receptor Potential Melastatin 8 stimulated by cold temperatures and menthol, which aid in the control and decrease of the thirst intensity for providing refreshment and satiety without, however, the necessity of fluid intake In high amounts.

详细描述

Thus, the present study aims to: compare the intensity and discomfort of thirst in the use of the menthol popsicle and usual care in patients in the preoperative period. This is a randomized clinical trial, to be performed in a public tertiary hospital. The sample size calculation will be performed after the pilot test is conducted. Two groups will be formed through randomization. The tested intervention consists of the menthol popsicle (experimental group). The thirst intensity (primary outcome) will be measured by means of the Numerical Scale and the discomfort of thirst (secondary outcome) through the Perioperative Seat Discomfort Scale, in two moments: at the end of the first approach of the patient and 20 minutes after the intervention. The results of this research may support the decision-making of health professionals in the implementation of effective and safe actions to manage the seat of the surgical patient in the preoperative period. Another relevant aspect is the production of knowledge about the problem, which is scarce both in the national and international scenario.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 60 years;
  • Without the use of pre-anesthetic medication, until the moment of data collection;
  • Conscious and alert, who recognizes himself and responds to the stimuli of the environment;
  • Oriented in relation to time and space;
  • Fasting for more than two hours at the time of data collection;
  • Minimum time of three hours prior to the scheduled time for surgery, to approach and collect data;
  • Report thirst.

排除标准

  • Presenting a contraindication of ingestion or swallowing;
  • Present mandibular trauma;
  • Being nauseated or vomiting;
  • Refer to allergy to mentha;
  • In dialysis;
  • Report sjogren's syndrome.

研究组 & 干预措施

Menthol Popsicle

Experimental

The patient will be questioned when the intensity and discomfort of thirst. After randomization, the patient assigned to the experimental group will experience a menthol popsicle. After 20 minutes of the end of the popsicle, will again be questioned as to the intensity and discomfort of thirst. The popsicle will have a support that will assist the patient in the administration of the intervention, giving him autonomy and safety in the application of the intervention.

干预措施: Menthol Popsicle (Other)

Usual care

No Intervention

The patient will be questioned when the intensity and discomfort of thirst. After randomization, the patient assigned to the control group should receive the usual care consisting of absolute fasting the food and drinks.

结局指标

主要结局

Intensity of thirst

时间窗: Measured at the beginning of the survey. For the experimental group, this measurement was measured again 20 minutes after tasting the menthol popsicle. For the control group, this measure was re-measured 20 minutes after the randomization.

Measured from zero to ten, where zero is no thirst and ten worst thirst.

Discomfort of thirst.

时间窗: Measured at the beginning of the survey. For the experimental group, this measurement was measured again 20 minutes after tasting the menthol popsicle. For the control group, this measure was re-measured 20 minutes after the randomization.

Measured according to the Perioperative Headquarters Discomfort Scale (EDESP). The final EDESP score ranges from zero to 14 points, 14 of which correspond to the most intense discomfort related to the perioperative seat.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Aroni

researcher

University of Sao Paulo

研究点 (2)

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