ThirstNCT03621800
Menthol Popsicle to Manage the Elderly Patient's Thirst in the Immediate Postoperative Period
A study testing Menthol popsicle in people with Thirst, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Thirst is defined as the desire for water seeking and consumption, and is a prevalent symptom in the immediate postoperative period in all age groups. The elderly surgical patient, despite presenting reduced physiological responses to thirst and satiety, in clinical practice, it is observed that they have high thirst… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Thirst
- 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
- 7 Jun 2018to 1 Aug 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Surgeries;
- Aged 60 years and over;
- Being fasting;
- Verbalize thirst;
- Have been approved in the assesment of Safety Protocol of Thirst Management (SPTM)
Who cannot join
- Patients with ingestion and swallowing restrictions;
- Patients with self-reported allergy to mint;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of the Menthol Popsicle to Manage the Elderly Patient's Thirst in the Immediate Postoperative Period: a Randomized Clinical Trial
Thirst is defined as the desire for water seeking and consumption, and is a prevalent symptom in the immediate postoperative period in all age groups. The elderly surgical patient, despite presenting reduced physiological responses to thirst and satiety, in clinical practice, it is observed that they have high thirst intensity. There is evidence that strategies using cold temperatures are effective in quenching thirst of the surgical patient, for this reason, the present study is justified, in order to find strategies that help to reduce thirst in this specific population that is the elderly surgical patient.
Read the detailed description
The present study aims to: compare the intensity and discomfort of thirst in the use of the menthol popsicle and usual care in elderly patients in the immediate postoperative 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). Thirst intensity (primary outcome) will be measured by means of the Visual Numerical Scale and the discomfort of thirst (secondary outcome) through the Perioperative Thirst Discomfort Scale, in two moments: at the end of the first assesment of the patient and 20 minutes after the intervention. With the results of this study the intend is to offer to the scientific society subsidies on thirst presented by the elderly patients, generating evidence for the improvement of clinical practice. In addition to contributing to the preparation of health professionals in the assertive care of the elderly population, it is estimated to deepen the knowledge about appropriate and innovative interventions to manage the postoperative thirst of the elderly, considered to be this, a representative and growing part of the world population.
- Conditions
- Thirst
- Being tested
- Menthol popsicle
- Keywords
- Thirst, Elderly, Postoperative Period, Surgical Patient, Menthol, Ice, Randomized Controlled Trial
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, 20ml ultrafiltered water and 2% cereal alcohol. The menthol popsicle was supported by a stick, allowing patients to taste more comfortably, with autonomy and safety
| Study group | Role | What they receive |
|---|---|---|
| Menthol popsicle | Experimental | Allocation concealment was performed through the use of individual opaque envelopes numbered externally in sequence, containing the randomly defined group information.This was performed by a researcher who did not participate in the data collection. The intensity of the initial thirst was measured by Visual Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After 20 minutes of the intervention (menthol popsicle), the final intensity and discomfort were measured using the same scales. Receives: Other: Menthol popsicle |
| Usual care (maintenance of fasting) | No intervention | When allocated in the control group, the intensity of the initial thirst was measured by Visual Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After maintaining the usual care, that is, reaffirming the need for absolute fasting of food and drinks for 20 minutes, the final intensity and discomfort were measured using the same scales. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thirst intensity
For assesment of thirst intensity , a Visual Numeral Scale (VNS) was used, with a range from 0 (no thirst) to 10 (very intense thirst), as reported by the patients when questioned.
Measured: Measured at the beginning of the survey. For the experimental group, this measurement was made again 20 minutes after tasting the menthol popsicle. For the control group, this measure was made 20 minutes after the randomization
Secondary outcomes (1)
Thirst discomfort
The Perioperative Thirst Discomfort Scale (PTDS) was used to assess thirst discomfort. This scale is composed of 7 attributes that evaluate the signs of discomfort of perioperative thirst, as follows: dry mouth, dry lips, thick tongue, thick saliva, bad taste in the mouth, and desire to drink water. Each attribute varies between 0 (not uncomfortable), 1 (a little uncomfortable), and 2 (very uncomfortable). The final sum of the PTDS can range from 0 to 14 points, and 14 corresponds to the most intense thirst discomfort reported by the patient.
Measured: Measured at the beginning of the survey. For the experimental group, this measurement was made again 20 minutes after tasting the menthol popsicle. For the control group, this measure was made 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 posted8 Aug 2018
- Study start7 Jun 2018
- Primary completion20 Jul 2018
- Study completion1 Aug 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a study with an experimental research design. Randomized clinical trial, parallel, prospective and monocentric.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Responsible party
- Principal investigator, Marilia Ferrari Conchon, University of Sao Paulo
- Investigators
- Cristina M Galvão, Study director, University of Sao PauloLigia F Fonseca, Study director, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621800
- Sponsor's protocol ID
- 87689318.4.0000.5393
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 8 Aug 2018
- 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 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Menthol Popsicle to Manage the Elderly Patient's Thirst in the Immediate Postoperative Period: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03621800
- Acronym / sponsor ID
- 87689318.4.0000.5393
- Conditions
- Thirst
- Keywords
- Thirst, Elderly, Postoperative Period, Surgical Patient, Menthol, Ice, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Universidade Estadual de Londrina
- Study start
- 7 Jun 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 8 Aug 2018 (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 for water seeking and consumption, and is a prevalent symptom in the immediate postoperative period in all age groups. The elderly surgical patient, despite presenting reduced physiological responses to thirst and satiety, in clinical practice, it is observed that they have high thirst intensity. There is evidence that strategies using cold temperatures are effective in quenching thirst of the surgical patient, for this reason, the present study is justified, in order to find strategies that help to reduce thirst in this specific population that is the elderly surgical patient.
Detailed description
The present study aims to: compare the intensity and discomfort of thirst in the use of the menthol popsicle and usual care in elderly patients in the immediate postoperative 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). Thirst intensity (primary outcome) will be measured by means of the Visual Numerical Scale and the discomfort of thirst (secondary outcome) through the Perioperative Thirst Discomfort Scale, in two moments: at the end of the first assesment of the patient and 20 minutes after the intervention. With the results of this study the intend is to offer to the scientific society subsidies on thirst presented by the elderly patients, generating evidence for the improvement of clinical practice. In addition to contributing to the preparation of health professionals in the assertive care of the elderly population, it is estimated to deepen the knowledge about appropriate and innovative interventions to manage the postoperative thirst of the elderly, considered to be this, a representative and growing part of the world population.
Study design
- Primary purpose
- Other
- 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. Randomized clinical trial, parallel, prospective and monocentric.
| Arm | Type | Receives |
|---|---|---|
| Menthol popsicle | Experimental | Other: Menthol popsicleAllocation concealment was performed through the use of individual opaque envelopes numbered externally in sequence, containing the randomly defined group information.This was performed by a researcher who did not participate in the data collection. The intensity of the initial thirst was measured by Visual Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After 20 minutes of the intervention (menthol popsicle), the final intensity and discomfort were measured using the same scales. |
| Usual care (maintenance of fasting) | No intervention | –When allocated in the control group, the intensity of the initial thirst was measured by Visual Numerical Scale (VNS), which ranged from 0 (no thirst) to 10 (very intense thirst) and the discomfort of the initial thirst was measured through the Perioperative Thirst Discomfort Scale (PTDS), which is composed of 7 attributes and ranges from 0 to 14. After maintaining the usual care, that is, reaffirming the need for absolute fasting of food and drinks for 20 minutes, the final intensity and discomfort were measured using the same scales. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elective Surgeries;
- Aged 60 years and over;
- Being fasting;
- Verbalize thirst;
- Have been approved in the assesment of Safety Protocol of Thirst Management (SPTM)
Key exclusion criteria (2 listed)
- Patients with ingestion and swallowing restrictions;
- Patients with self-reported allergy to mint;
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, 20ml ultrafiltered water and 2% cereal alcohol. The menthol popsicle was supported by a stick, allowing patients to taste more comfortably, with autonomy and safety | Other | Menthol popsicle |
Primary outcome
Thirst intensity
Time frame: Measured at the beginning of the survey. For the experimental group, this measurement was made again 20 minutes after tasting the menthol popsicle. For the control group, this measure was made 20 minutes after the randomization
For assesment of thirst intensity , a Visual Numeral Scale (VNS) was used, with a range from 0 (no thirst) to 10 (very intense thirst), as reported by the patients when questioned.
1 secondary outcome
Thirst discomfort
Time frame: Measured at the beginning of the survey. For the experimental group, this measurement was made again 20 minutes after tasting the menthol popsicle. For the control group, this measure was made 20 minutes after the randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- 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.
Cristina M Galvão study director
University of Sao Paulo
Ligia F Fonseca study director
Universidade Estadual de Londrina
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, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 8 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thirst intensity (time frame: Measured at the beginning of the survey. For the experimental group, this measurement was made again 20 minutes after tasting the menthol popsicle. For the control group, this measure was made 20 minutes after the randomization). 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 8 Aug 2018.