Investigating the effect of essential oil of the thyme on oral microbial burden in mechanical ventilated ICU patients
Design
A clinical trial with a control group with double-blind, randomized parallel groups
Settings and conduct
Mouthwash was used in all three groups of patients in mouth , gums , pharynx and teeth for 6 minutes. at the end , the solution is removed from the patient 's mouth by suctioning. the duration of the intervention will be the same in 3 groups and patient's position will be supine during the intervention.
Additionally, repeated washing of hands and putting the sterile gloves before and after mouthwashes will be performed.
Participants/Inclusion and exclusion criteria
The participants in the study included all patients under mechanical ventilation admitted to the intensive care unit.
Inclusion criteria:
The patient is under mechanical ventilation in the intensive care unit
Patients who do not have a inhibition for mouthwash.
Exclusion criteria:
Extenuation of the patient based on physician order during the study
Patient's death during the study
Patients diagnosed with brain death
History of allergy to various compounds of thyme and mint
Discharge of the patient from the intensive care unit
Intervention groups
Group 1: Mouthwash group with Thyme essential oil. The mouthwash used by Thyme Essential Oil from Barij Essen in the form of Glycoid10% solution is used
Group 2: Mouthwashes with chlorohexidine 0.2% of Iran's Healthcare Company.
The third group is the control group, in which the patients will use normal saline for mouth and throat washing.
Main outcome variables
The variable of the main outcome is oral microbial load that will be evaluated before and after the mouthwash.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100124003146N6
Registration date:2019-03-10, 1397/12/19
Registration timing:registered_while_recruiting
Last update:2019-03-10, 1397/12/19
Update count:0
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Ismail Azizi-Fini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
azizi-es@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of essential oil of thyme on oral microbial burden in mechanical ventilated ICU patients.
Public title
Investigating the effect of essential oil of thyme on oral microbial burden in mechanical ventilated ICU patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients under the mechanical ventilation in intensive care units
Exclusion criteria:
Patients with no prohibition for mouthwash
Patients with no sensitivity to thyme
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with inclusion criteria were randomly divided into three groups.Equal number of sample was allocated to each group using a randomized block method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because participating patients have low level of consciousness and are ventilated, are not aware of the type of intervention (mouthwash) and are blind. On the other hand, the person who analyzes the culture is not aware of the type of mouthwash used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
5th kilometer Qotb Ravandi blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1397.050
Health conditions studied
1
Description of health condition studied
oral thrush
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis
Primary outcomes
1
Description
oral microbial load
Timepoint
before using mouthwash and seven days after the intervention
Method of measurement
oral culture
Secondary outcomes
1
Description
anti bio-gram
Timepoint
before and seven days after intervention
Method of measurement
sample of oral culture
Intervention groups
1
Description
intervention group1: Mouthwash group with Thyme essential oil. The mouthwash, which is made by Barij essence company is made up of 10% glycidic solution, will be used twice a day (morning and night) for patients.So that the entire level of the mouth, gums, pharynx and tooth surfaces are swabbed for 6 minutes with 5 cc of solution.At the end of the mouthwash, the solution is removed from the mouth by suction (a sterile catheter without previous use).
Category
Treatment - Drugs
2
Description
Intervention group2: Mouthwash group with chlorohexidine 0.2% of Iran's Health Generation Company. So that the entire level of the mouth, gums, pharynx and tooth surfaces are swabbed for 6 minutes with 5 cc of solution.At the end of the mouthwash, the solution is removed from the mouth by suction (a sterile catheter without previous use).
Category
Treatment - Drugs
3
Description
Control group: The normal saline will be used.So that, the entire level of the mouth, gums, pharynx and tooth surfaces are swabbed for 6 minutes with 5 cc of solution.At the end of the mouthwash, the solution is removed from the mouth by suction (a sterile catheter without previous use).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital of kashan
Full name of responsible person
Dr Mohammadreza Fazel
Street address
5th kilometer Qotb Ravandi Blouvar.Parastar blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0026
Fax
Email
zahra31260@gmail.com
Web page address
http://beheshti.kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Hamidreza Banafshe
Street address
5th Kilometer Qotb Ravandi.Kashan university of medical sciences
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
zahra31260@gmail.com
Web page address
http://kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr Esmail Azizi-Fini
Position
assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5Th Kilometer Qotb Ravandi blouvar.kashan university of medical sciences
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizi-es@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Esmail Azizi-Fini
Position
َassisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5th kilometer Qotb Ravandi Blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizi-es@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr Esmail Aziz-Fini
Position
َassisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
5th kilometer Qotb Ravandi Blouvar
City
kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
azizi-es@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
the results related to the main outcome will be distributed.
When the data will become available and for how long
after the publication of the article
To whom data/document is available
all people
Under which criteria data/document could be used
data will be confidential
From where data/document is obtainable
aziz-es@kaums.ac.ir
What processes are involved for a request to access data/document