Protocol summary

Summary
-This random study was done to compare the effect of nursing interventions on reducing the severity and distress of thirst and mouth dryness after coronary artery bypass in cardiac surgery ICU departments. The sample volume will be 80 people. There will be no age limit and the patients will enter the research if they do not have any history of open-heart surgery and background diseases like diabetes. The patients will be randomly divided into two groups of case and control. The control group (20 people) will be intubated and NPO for at least 4 to 6 hours as the routine of surgery department. The case group will get divided into three groups including group A (water spray) (20 people), group B (moisture tissue) (20 people) and group C (sterile ice cubes) (20 people). For group A, 2 milliliters of water is sprayed directly into mouth so that tongue surface and mucous is moist. Gauze is completely moistened with distilled water for group B and it is repeated every 15 minutes. For group C, 2 milliliters of ice is put in patient’s mouth if they want. Data is collected through demographic questionnaire, and VAS scale is used to evaluate thirst severity and distress, and type of mouth dryness. The questionnaire is completed based on patients’ statements and direct observations 15 minutes after each intervention. Variables of first outcome evaluated in this research include thirst distress, thirst severity, and mouth dryness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040227176N1
Registration date: 2016-08-21, 1395/05/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-21, 1395/05/31
Registrant information
Name
Ghazal Seif
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0583
Email address
gh.seif@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of nursing nterventions on relieving of the patients' intensity and distress of thirsty and dry mouth after coronary artery bypass graft
Public title
Thirsty management of Patients after open heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Conditions for entering the research: lack of open-heart surgery history; completely able to read and write in Persian; lack of psychological and mental disorders history; not being affected by any background disease like diabetes or renal disease; lack of open wounds or diseases resulting in mouth and lips scaling Conditions of exclusion from the research: heart attack or brain stroke during the study; having another surgery during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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 Hamedan University of Medical Sciences
Street address
Hamedan SHaheid Beheshty Blvd, across from People's Park
City
Hamedan
Postal code
Approval date
2016-02-27, 1394/12/08
Ethics committee reference number
IR.UMSHA.REC.1394.529

Health conditions studied

1

Description of health condition studied
R68 Other general symptoms and signs
ICD-10 code
R68.2
ICD-10 code description
Dry mouth, unspecified

Primary outcomes

1

Description
Thirst distress
Timepoint
Every 15 minutes after intervention
Method of measurement
Visual Analogue Scales

2

Description
Thirst severity
Timepoint
Every 15 minutes after intervention
Method of measurement
Visual Analogue Scales

3

Description
Mouth dryness
Timepoint
Every 15 minutes after intervention
Method of measurement
Mouth dryness Form

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: (water spray) 2 milliliters of distilled water (room temperature) is directly sprayed into the mouth by commercially available containers so that tongue surface and mucous is moist. It is performed every 15 minutes.
Category
Other

2

Description
Control group: this group is provided by routine cares and are intubated and NPO at least 4 to 6 hours.
Category
Other

3

Description
Intervention group 2: (ice cubes) 2 milliliters is put in the patient’s mouth. It is done every 15 minutes.
Category
Other

4

Description
Intervention group 3: (moist gauze) the gauze is completely moistened with distilled water and it is repeated every 15 minutes.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialist Hospital Heart Farshchian
Full name of responsible person
Ghazal Seif
Street address
Hamedan SHaheid Fahmide Blvd،Specialist Hospital Heart Farshchian
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Vice-Chancellor Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian- Deputy Minister for Research and Technology
Street address
Hamedan, SHaheid Beheshty Blvd-across from People's Park
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Vice-Chancellor Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahnaz KHatiban
Position
Nursing PhD
Other areas of specialty/work
Street address
Hamedan SHaheid Beheshty Blvd, across from People's Park
City
Hamedan
Postal code
Phone
+98 81 3838 0583
Fax
Email
mahnaz.khatiban@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahnaz KHatiban
Position
Nursing PhD
Other areas of specialty/work
Street address
Hamedan SHaheid Fahmide Blvd,across from People's Park
City
Hamedan
Postal code
Phone
+98 81 3838 0583
Fax
Email
mahnaz.khatiban@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ghazal Seif
Position
Master of Science in Nursing/ nurse
Other areas of specialty/work
Street address
Hamedan SHahied Beheshty Blvd,across from the People's Park
City
Hamedan
Postal code
38698-65178
Phone
+98 81 3838 0583
Fax
Email
gh.seife@edu.umsha.ac.ir
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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