NCT02149394

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

May 17, 2014

Last Update Submit

May 26, 2014

Conditions

Keywords

ThirstIceWaterPerioperative NursingRecovery Room

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

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.

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.

Other: Water at room temperature

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.

Ice

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.

Water

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Marilia F Conchon

    Universidade Estadual de Londrina

    PRINCIPAL INVESTIGATOR
  • Ligia F Fonseca, PhD

    Universidade Estadual de Londrina

    STUDY DIRECTOR

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

Locations