ThirstNCT02149394
Ice Popsicle for Thirst Relief of the Surgical Patient
A study testing Ice popsicle and Water at room temperature in people with Thirst, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial summary
The purpose of this study is to assess the efficacy of ice popsicle compared with water at room temperature in relieving thirst in the immediate postoperative period . The hypothesis of the study is that ice has 20% greater efficacy than water to relieve thirst in the immediate postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thirst
- What is being tested?
- Ice popsicle and Water at room temperature
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Dec 2013
- 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
- aged between 18 and 65 years;
- undergoing more than eight-hour preoperative fasting;
- expressing thirst spontaneously or stimulated with intensity greater than or equal to three according to the numeric visual analogue scale;
- receiving opioids or anticholinergics during surgery;
- duration of anesthesia exceeding one hour;
- having been approved in the assessment by the Safety Protocol of Thirst Management;
- signing the informed consent during the preoperative period.
Who cannot join
- patients who had intake or swallowing restrictions.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University hospital - State University of Londrina
Londrina, Paraná, 86038-440
About this study
Official title: Efficacy of Ice Popsicle in the Management of Thirst in the Immediate Postoperative Period: Randomized Clinical Trial
The purpose of this study is to assess the efficacy of ice popsicle compared with water at room temperature in relieving thirst in the immediate postoperative period . The hypothesis of the study is that ice has 20% greater efficacy than water to relieve thirst in the immediate postoperative period.
Read the detailed description
There is evidence that ice is effective in relieving thirst in surgical patients, because, by stimulating the oral receptors sensitive to cold, ice decreases the need to ingest large volumes of liquids to satisfy thirst. This way, the risk of bronchoaspiration due to gastric fullness is avoided and discomfort with dry mouth is reduced. Preliminary evidence, therefore, indicates that the use of ice chips have greater efficacy than water at room temperature in relieving thirst. However, there is no scientific evidence from controlled studies with results that can be generalized with respect to a safe volume and adequate frequency of ice administered to reduce thirst in the immediate postoperative period.Considering that the gold standard for the study of a symptom is based on individuals' perceptions and their reports, this study is justified in order to assess the effectiveness of ice compared with water at room temperature in relieving thirst in the immediate postoperative period.
- Conditions
- Thirst
- Being tested
- Ice popsicle, Water at room temperature
- Keywords
- Thirst, Ice, Water, Perioperative Nursing, Recovery Room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice popsicleOther
Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The experimental group received an ice popsicle made of 10 mL mineral water.
The ice popsicles were made according to the predetermined volumes and packed in the freezer of the anesthetic recovery room at the institution researched. The block of ice were supported by a stick, allowing the patients to control the intensity of cold conferred by the ice for their comfort.
Water at room temperatureOther
Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The usual activities adopted by the nursing staff of the anesthetic recovery room were maintained for the control group that received 10 mL mineral water at room temperature in a syringe.
| Study group | Role | What they receive |
|---|---|---|
| Ice | Experimental | The concealment of allocation was performed through the use of individual opaque envelopes numbered externally in sequence, containing information of the group randomly defined. This step was carried out by a researcher who did not take part in data collection.Thirst intensity was measured within the range from 1 to 10 according to the numeric visual analogue scale.The experimental group received an ice popsicle made of 10 mL mineral water.The ice popsicles were made according to the predetermined volumes and packed in the freezer of the anesthetic recovery room at the institution researched. The block of ice was supported by a stick, allowing the patients to control the intensity of cold conferred by the ice for their comfort. Receives: Other: Ice popsicle |
| Water | Active comparator | The concealment of allocation was performed through the use of individual opaque envelopes numbered externally in sequence, containing information of the group randomly defined. This step was carried out by a researcher who did not take part in data collection.Thirst intensity was measured within the range from 1 to 10 according to the numeric visual analogue scale. The usual activities adopted by the nursing staff of the anesthetic recovery room were maintained for the control group that received 10 mL mineral water at room temperature in a syringe. Receives: Other: Water at room temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the intensity of the final thirst assessment with respect to the initial thirst assessment.
5 evaluations of thirst intensity every 15 minutes during the first hour postoperatively.
Thirst intensity was measured within the range from 1 to 10 in 1.0 intervals as reported by patients when orally required "how thirsty are you now?"according to the visual analogue scale. Zero means not thirsty at all and ten the worst thirst sensation that the patient have ever had.
Measured: 1 hour
Secondary outcomes (1)
Reaching the point of satiety over one-hour assessment presented by the experimental and control groups.
5 evaluations of thirst intensity and satiety every 15 minutes during the first hour postoperatively. Thirst intensity was measured within the range from 1 to 10 in 1.0 intervals as reported by patients when orally required "how thirsty are you now?"according to the visual analogue scale. Zero means not thirsty at all and ten the worst thirst sensation that the patient have ever had.according to the visual analogue scale. Satiety was characterized as intensity of thirst = zero (0).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marilia Ferrari Conchon, Universidade Estadual de Londrina
- Investigators
- Marilia F Conchon, Principal investigator, Universidade Estadual de LondrinaLigia F Fonseca, PhD, Study director, Universidade Estadual de Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149394
- Sponsor's protocol ID
- 16707313.5.0000.5231
- Status last verified
- May 2014
- First submitted
- 17 May 2014
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ice Popsicle in the Management of Thirst in the Immediate Postoperative Period: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02149394
- Acronym / sponsor ID
- 16707313.5.0000.5231
- Conditions
- Thirst
- Keywords
- Thirst, Ice, Water, Perioperative Nursing, Recovery Room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 May 2014 (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.
The purpose of this study is to assess the efficacy of ice popsicle compared with water at room temperature in relieving thirst in the immediate postoperative period . The hypothesis of the study is that ice has 20% greater efficacy than water to relieve thirst in the immediate postoperative period.
Detailed description
There is evidence that ice is effective in relieving thirst in surgical patients, because, by stimulating the oral receptors sensitive to cold, ice decreases the need to ingest large volumes of liquids to satisfy thirst. This way, the risk of bronchoaspiration due to gastric fullness is avoided and discomfort with dry mouth is reduced. Preliminary evidence, therefore, indicates that the use of ice chips have greater efficacy than water at room temperature in relieving thirst. However, there is no scientific evidence from controlled studies with results that can be generalized with respect to a safe volume and adequate frequency of ice administered to reduce thirst in the immediate postoperative period.Considering that the gold standard for the study of a symptom is based on individuals' perceptions and their reports, this study is justified in order to assess the effectiveness of ice compared with water at room temperature in relieving thirst in the immediate postoperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ice | Experimental | Other: Ice popsicleThe concealment of allocation was performed through the use of individual opaque envelopes numbered externally in sequence, containing information of the group randomly defined. This step was carried out by a researcher who did not take part in data collection.Thirst intensity was measured within the range from 1 to 10 according to the numeric visual analogue scale.The experimental group received an ice popsicle made of 10 mL mineral water.The ice popsicles were made according to the predetermined volumes and packed in the freezer of the anesthetic recovery room at the institution researched. The block of ice was supported by a stick, allowing the patients to control the intensity of cold conferred by the ice for their comfort. |
| Water | Active comparator | Other: Water at room temperatureThe concealment of allocation was performed through the use of individual opaque envelopes numbered externally in sequence, containing information of the group randomly defined. This step was carried out by a researcher who did not take part in data collection.Thirst intensity was measured within the range from 1 to 10 according to the numeric visual analogue scale. The usual activities adopted by the nursing staff of the anesthetic recovery room were maintained for the control group that received 10 mL mineral water at room temperature in a syringe. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged between 18 and 65 years;
- undergoing more than eight-hour preoperative fasting;
- expressing thirst spontaneously or stimulated with intensity greater than or equal to three according to the numeric visual analogue scale;
- receiving opioids or anticholinergics during surgery;
- duration of anesthesia exceeding one hour;
Key exclusion criteria (1 listed)
- patients who had intake or swallowing restrictions.
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 |
|---|---|---|
| Ice popsiclePatients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The experimental group received an ice popsicle made of 10 mL mineral water. The ice popsicles were made according to the predetermined volumes and packed in the freezer of the anesthetic recovery room at the institution researched. The block of ice were supported by a stick, allowing the patients to control the intensity of cold conferred by the ice for their comfort. | Other | Ice |
| Water at room temperaturePatients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The usual activities adopted by the nursing staff of the anesthetic recovery room were maintained for the control group that received 10 mL mineral water at room temperature in a syringe. | Other | Water |
Primary outcome
Change in the intensity of the final thirst assessment with respect to the initial thirst assessment.
Time frame: 1 hour
5 evaluations of thirst intensity every 15 minutes during the first hour postoperatively. Thirst intensity was measured within the range from 1 to 10 in 1.0 intervals as reported by patients when orally required "how thirsty are you now?"according to the visual analogue scale. Zero means not thirsty at all and ten the worst thirst sensation that the patient have ever had.
1 secondary outcome
Reaching the point of satiety over one-hour assessment presented by the experimental and control groups.
Time frame: 1 hour
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 29 May 2014.
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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.
Marilia F Conchon principal investigator
Universidade Estadual de Londrina
Ligia F Fonseca, PhD 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 Ice popsicle and Water at room temperature in people with Thirst, 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 1 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 29 May 2014. 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 the intensity of the final thirst assessment with respect to the initial thirst assessment. (time frame: 1 hour). 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 29 May 2014.