Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period.

Thirst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03236623
• Other study ID #: 7289
• Status: Recruiting
• Phase: N/A
• First received: July 27, 2017
• Last updated: October 24, 2017
• Start date: May 10, 2017
• Est. completion date: November 26, 2017

Study information

• Verified date: October 2017
• Source: University of Sao Paulo
• Contact: Aroni
• Phone: +5543999761025
• Email: aronipatricia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 26, 2017
• Est. primary completion date: September 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perioperative Nursing
• Thirst

Intervention

Other:
• Menthol Popsicle
The menthol popsicle composed of 0.05% menthol, 0.05% saccharin, 30ml ultrafiltered water and 2% cereal alcohol. 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.

Locations

Country	Name	City	State
Brazil	Patricia Aroni	Londrina	Paraná

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of thirst	Measured from zero to ten, where zero is no thirst and ten worst thirst.	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.
Primary	Discomfort of thirst.	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.	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.