Clinical trial NCT03236623: Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period.
Official title: The Use of the Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thirst
Perioperative Nursing
Keywords: Surgical Patient
Menthol
Clinical Study
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Universidade Estadual de Londrina
First posted: 2017-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a study with an experimental research design, such as a randomizedclinical trial, parallel, prospective and monocentric.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intensity of thirst
timeFrame: 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.
measure: Discomfort of thirst.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: Patricia Aroni
state: Paraná
Study officials:
affiliation: University of Sao Paulo
name: Patricia Aroni
role: PRINCIPAL_INVESTIGATOR
References: