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临床试验/NCT03200197
NCT03200197已完成不适用

Effectiveness of Menthol Chewing Gum in the Management of Preoperative Thirst: Randomized Clinical Trial

Universidade Estadual de Londrina0 个研究点目标入组 102 人开始时间: 2016年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
102
主要终点
intensity of thirst

研究概览

简要总结

The objective of this study was to compare the effectiveness of menthol chewing gum compared to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst during the preoperative period. The hypothesis of the study was that the use of menthol chewing gum in surgical patients in the preoperative period would be more effective than the maintenance of fasting with regard to the decrease in thirst and its discomforts.

详细描述

There is evidence that chewing gum is effective in relieving thirst in the surgical patient in the preoperative period as it stimulates the salivary glands by means of mechano and chemoreceptors, increasing the salivary pH and flow, lubricating the oral cavity, acting in this way on peripheral thirst, which is triggered by dehydration of the oral mucosa. Furthermore, menthol gum stimulates the cold receptors, known as TRPM8, which are responsible for deactivating centers of thirst. Thus, the risk of bronchoaspiration due to gastric fullness is avoided and the discomfort of a dry mouth is reduced.Preliminary evidence indicates that the chewing gum strategy assists in the relief of a dry mouth and thirst in patients undergoing dialysis and head and neck radiotherapy. However, there is no scientific evidence of controlled studies with results that can be generalized regarding the use of chewing gum to reduce thirst and its discomforts in surgical patients in the preoperative period when they remain in a fasted state.

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
12 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective Surgeries;
  • •Aged between 12 and 65 years;
  • •Did not receive preanesthetic medication;
  • •Oriented in time and space;
  • •Present dentition (natural or artificial);
  • •Fasting for a minimum of three hours;
  • •Available for collection at least 3 hours prior to the scheduled surgical procedure;
  • •Verbalize thirst spontaneously or when questioned with an intensity greater than or equal to three on the Verbal Numerical Scale (VNS);

排除标准

  • •Allergy to menthol;
  • •Chewing restriction;
  • •Swallowing restriction;
  • •Patients who presented nausea, vomiting, or pain;
  • •Patients with chronic xerostomia;
  • •Chronic renal patients;

研究组 & 干预措施

menthol chewing gum

Experimental

Allocation concealment was performed through the use of individual opaque envelopes numbered externally in sequence, containing the randomly defined group information.This step was performed by a researcher who did not participate in the data collection. The intensity of the initial thirst was measured by means of the Verbal Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After using the intervention (menthol chewing gum) for 10 minutes, chewing at a natural rhythm and swallowing the saliva produced, the intensity and final discomfort were measured using the same scales.

干预措施: Menthol chewing gum (Other)

Usual care (maintenance of fasting)

Active Comparator

Allocation concealment was performed through the use of individual opaque envelopes numbered externally in sequence, containing the randomly defined group information.This step was performed by a researcher who did not participate in the data collection.The intensity of the initial thirst was measured by means of the Verbal Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After maintaining the usual care, that is, reaffirming the need for fasting for 10 minutes, the intensity and final discomfort were measured using the same scales.

干预措施: Usual care (fasting) (Other)

结局指标

主要结局

intensity of thirst

时间窗: 10 minutes

Alteration in the evaluation of the final intensity of thirst in relation to the evaluation of the initial intensity of thirst \[10 minutes\]. For evaluation of the intensity of thirst, a Verbal Numeral Scale (VNS) was used, with a range from 0 (no thirst) to 10 (very intense thirst), as reported by the patients when questioned.

次要结局

  • discomfort of thirst(10 minutes)

研究者

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

Aline Korki Arrabal Garcia

Master of Science Degree in Nursing

Universidade Estadual de Londrina

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