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
1 other identifier
interventional
208
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 17, 2014
CompletedFirst Posted
Study publicly available on registry
May 29, 2014
CompletedMay 29, 2014
May 1, 2014
4 months
May 17, 2014
May 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 hour
Secondary Outcomes (1)
Reaching the point of satiety over one-hour assessment presented by the experimental and control groups.
1 hour
Study Arms (2)
Ice
EXPERIMENTALThe 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 COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- patients who had intake or swallowing restrictions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University hospital - State University of Londrina
Londrina, ParanĂ¡, 86038-440, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Marilia F Conchon
Universidade Estadual de Londrina
- STUDY DIRECTOR
Ligia F Fonseca, PhD
Universidade Estadual de Londrina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master of science degree in nursing
Study Record Dates
First Submitted
May 17, 2014
First Posted
May 29, 2014
Study Start
August 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 29, 2014
Record last verified: 2014-05