Management of Thirst, Nursing Care, Postoperative Care

August 26, 2019 updated by: esra eren, Istanbul Medipol University Hospital

The Effect of Oral Water and Ice Popsicle on Management of Thirst in the Immediate Postoperative Period.

The study was conducted to determine the effect of oral water and ice popsicle on management of thirst in the immediate postoperative period as experimental.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Also, it is aimed to evaluate validity and reliability of "Safety Protocol for Management Thirst in the Immediate Postoperative Period Protocol" which is used to take oral water and ice of patients in the immediate postoperative period, as administrative. The study was conducted with 150 patients who are transferred to the postanesthesia care unit (PACU) after their operation and met study criteria. Patients divided into three groups as the study (water group=50, ice group=50) and control (n=50). Patients in the study group were performed oral water/ice popsicle after their accession to PACU. However, the control group patients have performed rutin treatment and care without any other intervention. Physiologic variables and symptoms with thirst were followed in every three group patients at certain times. Data were evaluated by using NCSS (Number Cruncher Statistical System) 2007 program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kavacık, Turkey
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. have a surgical operation other than gastrointestinal system surgery,
  2. Surgical fasting duration is at least 8 hours,
  3. According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III;
  4. Having the ability to express the thirst status verbally and experiencing moderate or severe thirst when the thirst status is evaluated by VAS,
  5. The duration of anesthesia is longer than 1 hour and accepted into the PACU after surgery.

Exclusion Criteria:

  1. have a second surgical intervention during hospitalization,
  2. The need of intensive care after surgery,
  3. Having problems in the process of separation from respiratory support after surgical intervention,
  4. A change in the state of consciousness after surgical intervention / acute confusion,
  5. Liquid electrolyte imbalance,
  6. Patients with difficulty in swallowing or restriction of oral fluid intake,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: patients in the water group
water group: Patients in the water group were performed oral water after their accession to PACU.
Other: WATER
ORAL WATER
Experimental: patients in the ice group
ice group, Patients in the ice group were performed oral ice popsicle after their accession to PACU.
Other: ICE APPLICATION
ICE APPLICATION
No Intervention: no intervention group
control group, the control group patients have performed rutin treatment and care without any other intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
THIRSTY SCALE
Time Frame: first 30 minutes after the surgery
Thirsty and symptoms of thırsty evaluated via vısual analog scale which containing numbers from zero to ten (0-10), "0" is the minumun point, "10" is the maximum point, higher values represent a better situation.
first 30 minutes after the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The blood pressure measurements in the first 30 minutes after surgery
Time Frame: first 30 minutes after surgery
Blood pressure was obtained from the monitor data of patients who were monitored postoperatively. Blood pressure was measured as "mmHg".
first 30 minutes after surgery
The heart rate measurements in the first 30 minutes after surgery
Time Frame: first 30 minutes after surgery
Heart rate was obtained from the monitor data of patients who were monitored postoperatively. heart rate refers to the number of beats per minute.
first 30 minutes after surgery
The respiratory rate measurements in the first 30 minutes after surgery
Time Frame: first 30 minutes after surgery
The respiratory rate was obtained from the monitor data of the patients who were monitored postoperatively. respiration rate is the sum of inspiration and expiration per minute.
first 30 minutes after surgery
The body temperature measurements in the first 30 minutes after surgery
Time Frame: first 30 minutes after surgery
Body temperature was obtained from the monitor data of patients who were monitored postoperatively. body temperature was recorded with the degree system in degrees Celsius.
first 30 minutes after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: seher deniz öztekin, Prof.Dr., thesis advisor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 55323

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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