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The effect of honey lemon solution on the improvement of sore throat after intubation among candidates for general anesthesia

Protocol summary

Study aim
Evaluation of the effect of honey and lemon juice solution on postoperative sore throat
Design
This study is a single blind clinical trial. In this study, 86 patients will be randomly divided into intervention and control groups.
Settings and conduct
This study will be conducted at the 22 Bahman hospital in Neyshabur. Patients will enter the study after checking the inclusion criteria and informed consent. Then Demographic information and anesthetic information questionnaire is completed by the Collaborative nurse. In this study, patients are randomly divided into intervention and control groups. This study is single blind in which the nurse collecting information from the patients has no information about the groups patients are belonged to.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having Consent form, being satisfied the surgeon for swallowing of honey lemon juice solution , Candidate for general anesthesia and endotracheal intubation, The operating time is less than 6 hours, Age between 15 to 60, Ability to communicate and answer questions. Exclusion criteria: sensitivity to honey and lemon juice solution, having diabetes
Intervention groups
In the intervention group one hour after surgery and before intervention questionnaires about sore throat, cough and hoarseness will be completed. Then, after 6 hours of surgery, the patient will receive 30 cc of lemon juice and honey, Then After 12 and 24 hours after the intervention, the above mentioned questionnaires are completed. In the control group, normal saline will be used as a placebo.
Main outcome variables
In this study, postoperative sore throat, cough and hoarseness as a result of the study will be evaluated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150511022218N4
Registration date: 2018-08-19, 1397/05/28
Registration timing: registered_while_recruiting

Last update: 2018-08-19, 1397/05/28
Update count: 0
Registration date
2018-08-19, 1397/05/28
Registrant information
Name
Vahid Moeini Ghamchini
Name of organization / entity
Neyshabour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4261 4062
Email address
v.moinighamchini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-16, 1397/04/25
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of honey lemon solution on the improvement of sore throat after intubation among candidates for general anesthesia
Public title
The effect of honey lemon solution on postoperative sore throat
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having Consent form Surgeon satisfaction for patient ti drink honey and lemon juice solution Candidate for general anesthesia and endotracheal intubation The operating time less than 6 hours Age between 15 to 60 years old Ability to communicate and answer the questions
Exclusion criteria:
Being allergic to honey and lemon juice solution Having diabetes
Age
From 15 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 86
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, sampling is easy and accessible . patients are randomly dividing into intervention and control groups. It should be noted that the study samples are randomly divided into two groups through block randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single blind clinical trial in which the Nurse that helps researchers to fill out the questionnaire won't know the group patients are belong to.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Neyshabur University of Medical Sciences
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
6623451124
Approval date
2018-05-14, 1397/02/24
Ethics committee reference number
IR.NUMS.REC.1397.006

Health conditions studied

1

Description of health condition studied
postoperative sore throat
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
sore throat
Timepoint
One hour after surgery and before intervention, 12 and 24 hour after intervention
Method of measurement
Visual Analogue Scale( VAS )

Secondary outcomes

1

Description
Cough
Timepoint
One hour after surgery and before intervention, 12 and 24 hour after intervention
Method of measurement
questionnaire

2

Description
Hoarseness
Timepoint
One hour after surgery and before intervention, 12 and 24 hour after intervention
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: In the intervention group one hour after surgery and before intervention questionnaires about sore throat, cough and hoarseness will be completed. Then, after 6 hours of surgery, the patient will receive 30 cc of lemon juice and honey. The reconstituted solution will be provided to patients with clear containers. Prescribed solution will also be given to the patients 2 and 4 hours after the first dose. In general, each patient will use the solution mentioned 3 times. The Honey was produced by Khomein Company with a health license number 15/11066. The lemon juice was produced by the Yek&Yek company with a health license number 36/10374. Then After 12 and 24 hours after the intervention, the above mentioned questionnaires are completed again.
Category
Prevention

2

Description
Control group: In the Control group one hour after surgery questionnaires about sore throat, cough and hoarseness will be completed. In the control group, patients at the same time with the intervention group will use saline as placebo. Then After 12 and 24 hours after the intervention, the above mentioned questionnaires are completed again.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
22 Bahman Neyshabur Hospital
Full name of responsible person
mohammadreza Aryaeefar
Street address
Neyshabur University of Medical Sciences
City
neyshabur
Province
Razavi Khorasan
Postal code
6623451124
Phone
+98 51 4334 4711
Email
m.aryaee2012@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
mohammadreza Aryaeefar
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
6623451124
Phone
+98 51 4334 4711
Email
m.aryaee2012@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour University of Medical Sciences
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
Neyshabour University of Medical Sciences
Full name of responsible person
Mohammad Reza Aryaeefar
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
6623451124
Phone
+98 51 4334 4711
Email
m.aryaee2012@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mohammad Reza Aryaeefar
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
6623451124
Phone
+98 51 4334 4711
Email
m.aryaee2012@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mohammad Reza Aryaeefar
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Neyshabur University of Medical Sciences
City
Neyshabur
Province
Razavi Khorasan
Postal code
6623451124
Phone
+98 51 4334 4711
Email
m.aryaee2012@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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