Protocol summary

Summary
This random study was done to compare the effect of nursing interventions on reducing the severity of thirst, nausea and Occurrence or Non-occurrence Vomit after coronary artery bypass in cardiac surgery ICU departments. The sample volume will be 78 people. In this study, age group 45-85 years old will be studied. The patients will be randomly divided into two groups of case and control. The test group is allowed to use isotonic fluids and the control group is allowed to use water, then 1 hour after the extubation up to 8 hours later. Data is collected through demographic questionnaire, and NRS scale is used to evaluate thirst and nausea severity, and Occurrence or Non-occurrence Vomit. The questionnaire is completed based on patients’ statements and direct observations. Variables of first outcome evaluated in this research include severity of thirst, nausea and Occurrence or Non-occurrence Vomit

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082116870N4
Registration date: 2017-09-11, 1396/06/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Khadije Nasiriani
Name of organization / entity
Yazd Shahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1755
Email address
nasiriani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-08-24, 1396/06/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of isotonic fluid and water intake on the thirst, nausea and vomiting in patients undergoing CABG surgery
Public title
Effect of isotonic fluid and water intake on the thirst, nausea and vomiting in patients undergoing CABG surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients have undergone a coronary artery bypass grafting with a pulmonary pump; In middle aged people (between 45 and 85 years old) and in both sexes can be studied; The patient has informed consent to enter the study. Exit criteria for the affected units: There are nausea and vomiting before using fluids, received anti-nausea drugs, received fluids through NGT.
Age
From 45 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Yazd University of Medical Sciences
Street address
School of Nursing & Midwifery, Buali street, Safaieh, Yazd
City
Yazd
Postal code
00983518241755
Approval date
2016-07-16, 1395/04/26
Ethics committee reference number
IR.SSU.MEDICINE.REC.1395.117

Health conditions studied

1

Description of health condition studied
Thirst
ICD-10 code
T73.1 Effe
ICD-10 code description
T73.1

Primary outcomes

1

Description
Thirst severity
Timepoint
Every 1 hour to 8 hours after extubation
Method of measurement
Numeric Rating Scale

Secondary outcomes

1

Description
Nausea severity
Timepoint
Every 1 hour to 8 hours after extubation
Method of measurement
Numeric Rating Scale

2

Description
Occurrence or Non-occurrence Vomit
Timepoint
Every 1 hour to 8 hours after extubation
Method of measurement
Researcher Direct Observations

Intervention groups

1

Description
The intervention group 1 (test group): is allowed to use isotonic fluids then 1 hour after extubation up to 8 hours after it.
Category
Other

2

Description
Intervention group 2 (control group): allowed to use water then 1 hour after extubation up to 8 hours after it
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Semnan University of Medical Sciences The Kosar Hospital of Semnan
Full name of responsible person
Malihe Ghazvini
Street address
Semnan – amin Avenue- Kosar Hospital
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
International College of Yazd Campus
Full name of responsible person
Finance
Street address
School of Nursing & Midwifery, Buali street, Safaieh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International College of Yazd Campus
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
khadijeh Nasiriani
Position
Nursing PhD
Other areas of specialty/work
Street address
School of Nursing Midwifery, Buali street, Safaieh, Yazd
City
Yazd
Postal code
Phone
+98 35 1824 1755
Fax
Email
nasiriani@gmail.com
Web page address
nasiriani@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
kamran ghods
Position
Cardiovascular Surgeon
Other areas of specialty/work
Street address
Semnan – Amin Avenue- Kosar Hospital
City
Semnan
Postal code
Phone
+98 23 3142 2111
Fax
Email
kamran1230@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Malihe ghazvini
Position
Master of Science in Nursing/ Nurse
Other areas of specialty/work
Street address
Semnan – amin Avenue- Kosar Hospital
City
Semnan
Postal code
Phone
+98 23 3142 2111
Fax
Email
malihe_ghazvini@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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