Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period.
The Use of the Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period: a Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2017
CompletedOctober 25, 2017
October 1, 2017
5 months
July 27, 2017
October 24, 2017
Conditions
Keywords
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
EXPERIMENTALThe 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.
Usual care
NO INTERVENTIONThe 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.
Eligibility Criteria
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
- University of Sao Paulolead
- Universidade Estadual de Londrinacollaborator
Study Sites (1)
Patricia Aroni
Londrina, ParanĂ¡, 86047160, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia Aroni
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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