ThirstNCT03236623
Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period.
A study testing Menthol Popsicle in people with Thirst and Perioperative Nursing, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thirst, Perioperative Nursing
- What is being tested?
- Menthol Popsicle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 10 May 2017to 26 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Patricia Aroni
Londrina, Paraná, 86047160
Patricia Aroni
About this study
Official title: The Use of the Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period: a Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Thirst, Perioperative Nursing
- Being tested
- Menthol Popsicle
- Keywords
- Surgical Patient, Menthol, Clinical Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol PopsicleOther
Also called Menthol Ice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of thirst
Measured from zero to ten, where zero is no thirst and ten worst thirst.
Measured: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start10 May 2017
- Primary completion26 Sep 2017
- Study completion26 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThirstStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a study with an experimental research design, such as a randomizedclinical trial, parallel, prospective and monocentric.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Responsible party
- Principal investigator, Patricia Aroni, University of Sao Paulo
- Investigators
- Patricia Aroni, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03236623
- Sponsor's protocol ID
- 7289
- Status last verified
- Oct 2017
- First submitted
- 27 Jul 2017
- Last updated
- 25 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Menthol Popsicle to Manage the Patient's Seat in the Preoperative Period: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03236623
- Acronym / sponsor ID
- 7289
- Conditions
- Thirst, Perioperative Nursing
- Keywords
- Surgical Patient, Menthol, Clinical Study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Study start
- 10 May 2017 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 26 Nov 2017 (estimated)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a study with an experimental research design, such as a randomizedclinical trial, parallel, prospective and monocentric.
| Arm | Type | Receives |
|---|---|---|
| Menthol Popsicle | Experimental | Other: Menthol PopsicleThe 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 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- Presenting a contraindication of ingestion or swallowing;
- Present mandibular trauma;
- Being nauseated or vomiting;
- Refer to allergy to mentha;
- In dialysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menthol PopsicleAlso: Menthol IceThe 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. | Other | Menthol Popsicle |
Primary outcome
Intensity of thirst
Time frame: 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.
Measured from zero to ten, where zero is no thirst and ten worst thirst.
Discomfort of thirst.
Time frame: 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Thirst
Enrolling by invitation
Effect of Cold Water Spray on Swallowing Difficulty, Pain, and Thirst After Thyroid Surgery
Swallowing Difficulties, Thirst
Not yet recruiting
The Effects of Menthol and Cold Spray Applications on Thirst and Comfort in Bariatric Surgery
Thirst in Bariatric Surgery Patients
Recruiting
Administration of a 'Thirst Relieve Kit' Versus Placebo in Patients After Hospital-based Bowel Preparation for Colonoscopy and Assessment of Thirst Intensity
Thirst, Bowel Preparation for Colonoscopy
Recruiting
Thirst for Knowledge
Geriatric Population
Recruiting
Restrictive Versus Liberal Fluid Intake in Acute Decompensated Heart Failure
Acute Heart Failure (AHF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Aroni principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol Popsicle in people with Thirst and Perioperative Nursing, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aroni (+5543999761025, aronipatricia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of thirst (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2017.