ThirstNCT02869139
Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room
A study testing Mentholated lip moisturizer and ice popsicle and Non-mentholated lip moisturizer and ice popsicle in people with Thirst and Mouth Dryness, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thirst, Mouth Dryness, Irritation Lips
- What is being tested?
- Mentholated lip moisturizer and ice popsicle and Non-mentholated lip moisturizer and ice popsicle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Jan 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Possess aged between eighteen and sixty-five years
- To be fasting for more than four hours
- Verbalizing headquarters spontaneously or after questioning, with greater than or equal to three intensity in numerical verbal scale
- Receive opioids or anticholinergic during surgery duration of greater than one hour anesthesia
- Being in anesthetic recovery in anesthesia recovery room
- Have been approved in the evaluation Headquarter Insurance Management Protocol which was applied to both groups
- Accept participate and sign the consent form Clarified
Who cannot join
- Being allergic to menthol
- Have continuity of injury in the oral mucosa
- Having suspended the anesthetic-surgical procedure after acceptance of participation
- Receive High operating room directly to another healthcare sector than the anesthetic recovery room, and intensive care unit or hospital unit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room: Randomized Clinical Trial
Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial
Read the detailed description
Perioperative thirst is intense and has a high incidence. There is evidence that strategies using cold and menthol could be viable alternatives to reduce thirst and the discomforts arising from it. For that reason, this study evaluated the efficacy of a mentholated package of measures (lip moisturizer and ice popsicle) compared to a non-mentholated package of measures in alleviating thirst in the anesthesia recovery room.
- Conditions
- Thirst, Mouth Dryness, Irritation Lips
- Being tested
- Mentholated lip moisturizer and ice popsicle, Non-mentholated lip moisturizer and ice popsicle
- Keywords
- Thirst, Ice, Menthol, Perioperative Nursing., Recovery Room
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentholated lip moisturizer and ice popsicleOther
Mentholated package of measures
Non-mentholated lip moisturizer and ice popsicleOther
Non-mentholated package of measures
| Study group | Role | What they receive |
|---|---|---|
| Package of mentholated measures | Experimental | Package of mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group. Receives: Other: Mentholated lip moisturizer and ice popsicle |
| Package of non-mentholated measures | Active comparator | Package of non-mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group. Receives: Other: Non-mentholated lip moisturizer and ice popsicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intensity of thirst, lip hydration, dryness of the mouth and taste the final oral cavity above the original between the experimental and control groups.
The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).
Measured: three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation
Secondary outcomes (1)
Change in the extent of satiety point over an hour assessment, presented by experimental and control groups, and the number of interventions required in every moment of assessment and intervention for each group.
The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).
Measured: three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionJan 2016
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.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviane Moreira Serato, Universidade Estadual de Londrina
- Investigators
- Viviane Serato, Principal investigator, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869139
- Sponsor's protocol ID
- GPS Menthol
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02869139
- Acronym / sponsor ID
- GPS Menthol
- Conditions
- Thirst, Mouth Dryness, Irritation Lips
- Keywords
- Thirst, Ice, Menthol, Perioperative Nursing., Recovery Room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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.
Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial
Detailed description
Perioperative thirst is intense and has a high incidence. There is evidence that strategies using cold and menthol could be viable alternatives to reduce thirst and the discomforts arising from it. For that reason, this study evaluated the efficacy of a mentholated package of measures (lip moisturizer and ice popsicle) compared to a non-mentholated package of measures in alleviating thirst in the anesthesia recovery room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Package of mentholated measures | Experimental | Other: Mentholated lip moisturizer and ice popsiclePackage of mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group. |
| Package of non-mentholated measures | Active comparator | Other: Non-mentholated lip moisturizer and ice popsiclePackage of non-mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Possess aged between eighteen and sixty-five years
- To be fasting for more than four hours
- Verbalizing headquarters spontaneously or after questioning, with greater than or equal to three intensity in numerical verbal scale
- Receive opioids or anticholinergic during surgery duration of greater than one hour anesthesia
- Being in anesthetic recovery in anesthesia recovery room
Key exclusion criteria (4 listed)
- Being allergic to menthol
- Have continuity of injury in the oral mucosa
- Having suspended the anesthetic-surgical procedure after acceptance of participation
- Receive High operating room directly to another healthcare sector than the anesthetic recovery room, and intensive care unit or hospital unit
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 |
|---|---|---|
| Mentholated lip moisturizer and ice popsicleMentholated package of measures | Other | Package of mentholated measures |
| Non-mentholated lip moisturizer and ice popsicleNon-mentholated package of measures | Other | Package of non-mentholated measures |
Primary outcome
Change in intensity of thirst, lip hydration, dryness of the mouth and taste the final oral cavity above the original between the experimental and control groups.
Time frame: three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation
The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).
1 secondary outcome
Change in the extent of satiety point over an hour assessment, presented by experimental and control groups, and the number of interventions required in every moment of assessment and intervention for each group.
Time frame: three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation
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 16 Aug 2016.
- Individual participant dataSharing planned: Yes
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.
Viviane Serato principal investigator
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 Mentholated lip moisturizer and ice popsicle and Non-mentholated lip moisturizer and ice popsicle in people with Thirst and Mouth Dryness, run by Universidade Estadual de Londrina 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 4 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 16 Aug 2016. 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?
Change in intensity of thirst, lip hydration, dryness of the mouth and taste the final oral cavity above the original between the experimental and control groups. (time frame: three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation). 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 16 Aug 2016.