Comparison the effect of natural gum, water spray and wet gauze on patients thirsty after coronary artery bypass graft surgery
Design
Randomized clinical trial with three groups and parallel group
Settings and conduct
The present study is a randomized clinical trial on 120 patients after coronary artery bypass graft surgery in Farshchian Hospital of Hamadan. In this study, in the intervention groups, three methods of natural gum, water spray and wet gases will be compared to reduce thirst.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients are alert and NPO, Thirst expressed by patients undergoing coronary artery bypass graft surgery.
Exclusion criteria: Unwillingness to continue cooperation, Patient death
Intervention groups
Intervention group1: Natural gum is placed in the patient's mouth and they are asked to keep it in their mouths as much as possible. After 15 minutes, a new gum is given to the same size, and the patient is asked to keep it in his mouth for 15 minutes.
Intervention group2: Water spray dispersed twice in 15 minutes directly into the mouth to wet the surface of the tongue and mucus.
Intervention group3: Twice wet gauze will be placed directly on the surfaces of both lips for 15 minutes.
Main outcome variables
Thirst severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025929N19
Registration date:2018-12-24, 1397/10/03
Registration timing:registered_while_recruiting
Last update:2018-12-24, 1397/10/03
Update count:0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
Mehdi Molavi Vardanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3422 5056
Email address
m.molavi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of natural gum, water spray and wet gauze on patients thirsty after coronary artery bypass graft surgery.
Public title
Comparison the effect of natural gum, water spray and wet gauze on patients thirsty
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Thirst expressed by patients undergoing Coronary artery bypass graft surgery
Patients are alert and NPO.
Exclusion criteria:
Patient death
Unwillingness to continue cooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In the present study, the patients were registered according to the sample size (120) according to the entry criteria, and using the blocking method (using a three-block method, three letters A, B and C with different permutations we place blocks in blocks and randomly select 46 blocks and assign each block to 3 people) will be assigned to three groups.
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.UMSHA.REC.1397.490
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
Primary outcomes
1
Description
The intensity of thirst
Timepoint
After intervention
Method of measurement
Visula Analog Scale( VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Natural gum is placed in the patient's mouth and they are asked to keep it in their mouths as much as possible. After 15 minutes, a new gum is given to the same size, and the patient is asked to keep it in his mouth for 15 minutes
Category
Other
2
Description
Intervention group2: Water spray dispersed twice in 15 minutes directly into the mouth to wet the surface of the tongue and mucus.
Category
Other
3
Description
Intervention group3: Twice wet gauze will be placed directly on the surfaces of both lips for 15 minutes
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian hospital
Full name of responsible person
Mahnaz Khatiban
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mahnaz.khatiban@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
s-bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Deputy of research and technology
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mahnaz.khatiban@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahnaz Khatiban
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
mahnaz.khatiban@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Nouri Gholamizadeh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Fahmideh St., Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Province
Hamadan
Postal code
38698-65178
Phone
+98 81 3838 0535
Email
alirez.nouri10@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available