Determine the effect of thyme spray on oropharyngeal bacterial colonization in hospitalized patients in critical care units
Design
This is a double blind randomized controlled clinical trial with a parallel group design.
Settings and conduct
This is a randomized controlled clinical trial study in which three groups of thyme spray in addition to routine oral care, water spray in addition to routine oral care, and only routine oral care will be done on 90 patients with Glasgow's coma scale between 3 to 15 who hospitalized at critical care units at Kowsar hospital affiliated to Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient's level of consciousness is between 15-3 according to Glasgow's coma scale; the patient feed through the nasogastric tube.
Exclusion criteria: Maxillofacial trauma so that oral care is difficult; confirmed hypersensitivity to thyme compounds.
Intervention groups
All study groups are including a routine oral care, which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day. However, in addition to the abovementioned oral care, the intervention group will also receive four puffs Thyme spray (manufactured by: Zardband Company), four times a day, in the right and left buccal area for 48 hours; patients in the placebo group, will also receive four puffs distilled water spray (manufactured by: Samen Mashad Company) four times a day in the right and left buccal area for 48 hours; and the control group will not receive any additional care.
Main outcome variables
Oropharyngeal bacterial colonization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180623040212N1
Registration date:2019-07-21, 1398/04/30
Registration timing:registered_while_recruiting
Last update:2019-07-21, 1398/04/30
Update count:0
Registration date
2019-07-21, 1398/04/30
Registrant information
Name
hesamedin َAskari Majdabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
haskari68@sem.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
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
Effect of thyme spray on oropharyngeal bacterial colonization in patients hospitalized in critical care units
Public title
Effect of thyme Spray on oropharyngeal bacterial colonization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization time is less than 24 hours.
Patients' age between 15 to 75 years.
The patient's level of consciousness is between 3-15 according to Glasgow's coma scale.
The patient feed via nasogastric tube.
Exclusion criteria:
Immunodeficiency due to chemotherapy, radiotherapy and immunosuppressive diseases.
Confirmed hypersensitivity to thyme compounds.
Age
From 15 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly allocated in three groups: A- thyme spray with routine care, B- routine care plus water spray and C-routine care by using a web-based software for generating random numbers (Kitset, available from: https://kitset.ir/numbers/random). According to this method, each block will contain three randomly generated numbers 1 to 3 representing the aforementioned interventions A to C respectively. The allocation of patients to the groups will follow the sequence of the randomly generated numbers in each block.
Blinding (investigator's opinion)
Double blinded
Blinding description
Once each intervention is completed, the samples of the pharynx will be taken for culture; so that to prevent of any bias, a nurse who is responsible for gathering the samples of throat secretions, as well as the laboratory expert who tests the samples, and also the statistician who is responsible for analyzing data will be blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Semnan University of Medical Sciences and Health
Street address
Semnan University of Medical Sciences, Basidj boulevard
City
Semnan
Province
Semnan
Postal code
3514716989
Approval date
2018-05-20, 1397/02/30
Ethics committee reference number
IR.SEMUMS.REC.1397.078
Health conditions studied
1
Description of health condition studied
Oropharyngeal bacterial colonization
ICD-10 code
J02.9
ICD-10 code description
Acute pharyngitis, unspecified
Primary outcomes
1
Description
Oropharyngeal Bacterial colonization
Timepoint
Admission time at critical care unit (before intervention) and 48 hours later
Method of measurement
Evaluation of the number of bacterial colonies in the pharynx culture sample
2
Description
Beck Oral Assessment
Timepoint
Admission time at critical care unit (before intervention) and 48 hours later
Method of measurement
Beck Oral Assessment Scale
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group, in addition to routine oral care, which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day, while in semi-sitting position with 45 ° angle received Thyme spray produced by Zardband Company every 6 hours for 48 hours, two puffs in the right buccal portion and two puff at the left.
Category
Prevention
2
Description
Placebo group in addition to routine oral care, which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day, will receive distilled water spray manufactured by the Samen Mashad Company (Iran) in a similar container of Thyme spray every 6 hours for 48 hours, two puffs in the right buccal and 2 puffs in the left buccal area in semi-sitting position with a 45-degree bed angle.
Category
Placebo
3
Description
Control group receive only routine mouth care which consists of 0.2% chlorhexidine mouth washing, manufactured by Behsa Pharmaceutical Company (Iran), three times a day.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Elham Zamani pour
Street address
Kowsar hospital, Amin Blv. Golestan Township
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3142 2252
Email
aeein59@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blv.
City
Semnan
Province
Semnan
Postal code
3514716989
Phone
+98 23 3345 1336
Email
pz_kokh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohsen Soleimani
Position
Associate Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, 5 kilometer to Damghan road, Standard Sq., Semnan/Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
soli257@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Hesamedin Askari Majdabadi
Position
assistant prof.
Latest degree
Ph.D.
Other areas of specialty/work
Health Education and Health Promotion
Street address
Semnan University of Medical Sciences, 5 kilometer to Damghan road, Standard Sq., Semnan/Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
hesamaskari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham Zamanipoor
Position
Msc. Student in critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, 5 kilometer to Damghan road, Standard Sq., Semnan/Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 233336544192
Email
aeein1359@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available