The aim of this study is to evaluate the effect of green tea gargling solution on post-extubation cough, hoarseness and sore throat in patients undergone coronary artery bypass surgery. This study is single-blind randomized clinical trial with a sample size of 130 patients undergoing coronary artery bypass surgery. Sampling is convenience and allocation in two groups is random. The intervention group participants will be asked to gargle 30 cc of green tea solution. Patients of the control group gargled 30 cc of distilled water. An hour after extubation, the patients of the intervention group will be asked to gargle 30 cc of green tea and the patients of the control group will be asked to gargle 30 cc of distilled water every 6 hours (up to 24 hours) . The soret hroat, hoarseness and cough Questionnaire will be also filled out 6, 12, and 24 hours after endotracheal extubation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014043017483N2
Registration date:2014-12-06, 1393/09/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-06, 1393/09/15
Registrant information
Name
Mohammadreza Aryaeefar
Name of organization / entity
Neyshabur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4334 4712
Email address
m.aryaee2012@gmail.com
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-07-01, 1393/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of green tea solution gargling on the sore throat,cough and hoarseness after coronary artery bypasses grafting
Public title
The effect of green tea solution gargling on the sore throat,cough and hoarseness after coronary artery bypasses grafting
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included age of 30-70 years , no history of having cold or sore throat during the preceding week, and lack of drug addiction. Exclusion criteria included more than 1 attempt for intubation intubation and more than 30 seconds, Mallampati score of higher than 2, active airway infection, and history of allergy to green tea . Furthermore, patients who kept in the ICU with an endotracheal tube for more than 16 hours, and patients who were unable to communicate due to different reasons, such as dangerous dysrhythmias, bleeding, loss of consciousness, or any other reason, will be excluded from the study.
Age
From 36 years old to 70 years old
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
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical sciences
Street address
Imam Squar, Joybar 3way, Start of valiye asr highway, Mazandaran University of Medical Sciences
City
Sari
Postal code
Approval date
2014-07-09, 1393/04/18
Ethics committee reference number
1393,18,04
Health conditions studied
1
Description of health condition studied
Sore throat Cough
ICD-10 code
R05, J02
ICD-10 code description
Cough , acute sore throat
Primary outcomes
1
Description
Sore throat
Timepoint
0, 6 ,12 and 24 hour after endotracheal extubation
Method of measurement
Visual Analogue Scale (VAS)
2
Description
cough
Timepoint
0, 6 ,12 and 24 hour after endotracheal extubation
Method of measurement
4 Point Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group participants were asked to gargle 30 cc of green tea solution every 6 hours (up to 24 hours) .
Category
Prevention
2
Description
The control group participants were asked to gargle 30 cc of distilled water every 6 hours (up to 24 hours) .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran Heart Center
Full name of responsible person
Dr Aria Soleimani
Street address
Artesh Blv. Mazandaran Heart Center, Sari, Iran.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmad Ali Enayati
Street address
Moalem Squar, Research Council of Mazandaran University of Medical Sciences.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hedayat Jafari
Position
Faculty member
Other areas of specialty/work
Street address
Amir Mazandarani Blv, Nasibeh Faculty of Nursing and Midwifery
City
Sari
Postal code
Phone
+98 15 1326 1245
Fax
Email
hedayat2003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hedayat Jafari
Position
PhD in Nursing
Other areas of specialty/work
Street address
Amir Mazandarani Blv, Nasibeh Faculty of Nursing and Midwifery
City
Sari
Postal code
Phone
+98 15 1326 1245
Fax
Email
hedayat2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mohammadreza Aryaeefar
Position
MSc student
Other areas of specialty/work
Street address
Amir Mazandarani Blv, Nasibeh Faculty of Nursing and Midwifery
City
Sari
Postal code
Phone
+98 15 1326 1245
Fax
Email
m.aryaee2012@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)