NCT03236623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2017

Completed
Last Updated

October 25, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

July 27, 2017

Last Update Submit

October 24, 2017

Conditions

Keywords

Surgical PatientMentholClinical Study

Outcome Measures

Primary Outcomes (2)

  • 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.

  • 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.

Study Arms (2)

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.

Other: Menthol Popsicle

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.

Interventions

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.

Also known as: Menthol Ice
Menthol Popsicle

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patricia Aroni

Londrina, ParanĂ¡, 86047160, Brazil

RECRUITING

Study Officials

  • Patricia Aroni

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a study with an experimental research design, such as a randomizedclinical trial, parallel, prospective and monocentric.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 2, 2017

Study Start

May 10, 2017

Primary Completion

September 26, 2017

Study Completion

November 26, 2017

Last Updated

October 25, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations