- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070911
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
150
Phase
- 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
-
-
-
Kavacık, Turkey
- İstanbul 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
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- have a surgical operation other than gastrointestinal system surgery,
- Surgical fasting duration is at least 8 hours,
- According to the American Society of Anesthesiologists (ASA) classification; Class I, II and III;
- Having the ability to express the thirst status verbally and experiencing moderate or severe thirst when the thirst status is evaluated by VAS,
- The duration of anesthesia is longer than 1 hour and accepted into the PACU after surgery.
Exclusion Criteria:
- have a second surgical intervention during hospitalization,
- The need of intensive care after surgery,
- Having problems in the process of separation from respiratory support after surgical intervention,
- A change in the state of consciousness after surgical intervention / acute confusion,
- Liquid electrolyte imbalance,
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: patients in the water group
water group: Patients in the water group were performed oral water after their accession to PACU.
|
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.
|
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
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
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.
Investigators
- 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)
November 24, 2015
Primary Completion (Actual)
July 13, 2018
Study Completion (Actual)
July 13, 2018
Study Registration Dates
First Submitted
May 23, 2019
First Submitted That Met QC Criteria
August 26, 2019
First Posted (Actual)
August 28, 2019
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 26, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID 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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