- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149394
Ice Popsicle for Thirst Relief of the Surgical Patient
Efficacy of Ice Popsicle in the Management of Thirst in the Immediate Postoperative Period: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Paraná
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Londrina, Paraná, Brazil, 86038-440
- University hospital - State University of Londrina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- patients who had intake or swallowing restrictions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ice
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.
|
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. |
ACTIVE_COMPARATOR: Water
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reaching the point of satiety over one-hour assessment presented by the experimental and control groups.
Time Frame: 1 hour
|
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).
|
1 hour
|
Collaborators and Investigators
Investigators
- Principal Investigator: Marilia F Conchon, Universidade Estadual de Londrina
- Study Director: Ligia F Fonseca, PhD, Universidade Estadual de Londrina
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16707313.5.0000.5231
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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