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General information
2019-08-06, 1398/05/15
2023-03-11, 1401/12/20
20192023-0803-0611 00:00:00
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Student problems related to pregnancy and childbirth, having a baby, have led to delays in the sampling process.
Student problems related to pregnancy and childbirth, having a baby, have led to delays in the sampling process.
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مشکلات دانشجو در رابطه با بارداری و زایمان، داشتن نوزاد، منجر به تاخیر در نمونه گیری گردیده است.
مشکلات دانشجو در رابطه با بارداری و زایمان، داشتن نوزاد، منجر به تاخیر در نمونه گیری گردیده است.
Recruitment centers
#1
Name of recruitment center - English: Imam Hussein (AS) and Bahar hospitals in Shahroud
Name of recruitment center - Persian: بیمارستان های امام حسین (ع) و بهار در شاهرود
Full name of responsible person - English: Monir Nobahar
Full name of responsible person - Persian: منیر نوبهار
Street address - English: Semnan University of Medical Sciences, Basij Blv, Semnan.
Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3365 4190
Fax: +98 23 3365 4209
Email: Nobahar43@semums.ac.ir
Web page address:
Name of recruitment center - English: Imam Hussein (AS) and Bahar hospitals in Shahroud
Name of recruitment center - Persian: بیمارستان های امام حسین (ع) و بهار در شاهرود
Full name of responsible person - English: Monir Nobahar
Full name of responsible person - Persian: منیر نوبهار
Street address - English: Semnan University of Medical Sciences, Basij Boulevard, Semnan.
Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3365 4190
Fax: +98 23 3365 4209
Email: Nobahar43@semums.ac.ir
Web page address:
Name of recruitment center - English: Imam Hussein (AS) and Bahar hospitals in Shahroud Name of recruitment center - Persian: بیمارستان های امام حسین (ع) و بهار در شاهرود Full name of responsible person - English: Monir Nobahar Full name of responsible person - Persian: منیر نوبهار Street address - English: Semnan University of Medical Sciences, Basij BlvBoulevard, Semnan. Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3513138111 Phone: +98 23 3365 4190 Fax: +98 23 3365 4209 Email: Nobahar43@semums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz Kokhaei
Full name of responsible person - Persian: پرویز کوخایی
Street address - English: Semnan University of Medical Sciences, Basij Blv, Semnan
Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3345 1336
Fax: +98 23 3365 4209
Email: P_kokha@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz Kokhaei
Full name of responsible person - Persian: پرویز کوخایی
Street address - English: Semnan University of Medical Sciences, Basij Boulevard, Semnan
Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 3513138111
Phone: +98 23 3345 1336
Fax: +98 23 3365 4209
Email: P_kokha@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Parviz Kokhaei Full name of responsible person - Persian: پرویز کوخایی Street address - English: Semnan University of Medical Sciences, Basij BlvBoulevard, Semnan Street address - Persian: سمنان، بلوار بسیج، دانشگاه علوم پزشکی City - English: Semnan City - Persian: سمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 3513138111 Phone: +98 23 3345 1336 Fax: +98 23 3365 4209 Email: P_kokha@yahoo.com Web page address:
Protocol summary
Study aim
Determine the effect of Propolis mouthwash on incidence of Ventilator Associated Pneumonia in hospitalized patient in critical care units.
Design
This is a double blind randomized controlled clinical trial with a parallel group design.
Settings and conduct
This study is done in ICU Imam Hussein (AS) and Bahar hospitals in Shahroud. Intervention in both groups is the same and randomize. Patients of experimental and control groups receive daily twice Propolis and Chlorhexidine mouthwash, respectively. Patients are mouthwash for 7 days and ventilator-associated pneumonia assessed in 1th; 3th; 5th and 7th days. Nurse and the data analyst are blinded to the allocation status.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients 18-75 years old; Under mechanical ventilation for more than 48 hours; Glasgow Coma scale between 6-11; Feeding with gastric tube; No contraindications to oral care; Propolis insensitivity. Exclusion criteria: Tracheotomy; Jaw and facial trauma; Weakness of the immune system.
Intervention groups
In the intervention group, mouthwash by using Propolis solution, each containing 3 mg of propolis in 1 ml, are doing twice a day in 8 am and 4 pm for 7 days. In the control group, mouthwash using Chlorhexidine 0.2% solution, twice a day in 8 am and 4 pm for 7 days.
Main outcome variables
Ventilator-Associated Pneumonia
General information
Reason for update
Student problems related to pregnancy and childbirth, having a baby, have led to delays in the sampling process.
Acronym
IRCT registration information
IRCT registration number:IRCT20110427006318N12
Registration date:2019-04-02, 1398/01/13
Registration timing:registered_while_recruiting
Last update:2022-04-18, 1401/01/29
Update count:1
Registration date
2019-04-02, 1398/01/13
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2023-03-11, 1401/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Propolis mouthwash on incidence of Ventilator-Associated Pneumonia in hospitalized patient in critical care unit
Public title
Effect of Propolis mouthwash on incidence of Pneumonia in hospitalized patient in critical care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 18-75 years old
Under mechanical ventilation for more than 48 hours
Glasgow Coma scale between 6-11
Feeding with gastric tube
No contraindications to oral care
Propolis insensitivity
Exclusion criteria:
Tracheotomy
Jaw and facial trauma
Weakness of the immune system
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
The research sample assigned to the groups of the study by permuted blocks randomization. In order to establish the number of samples assigned to each group (intervention and control), a random method with 4 blocks is used, so that each block has an equal number of each group, and the research sample assigned to the groups of the study by blocks randomization. Also blocking is used within age, sex and mode of the mechanical ventilation device. According to the age, sex and mode of mechanical ventilation variables are influence factors to the ventilator associated pneumonia; patients are selected and blocked that they are similar to another age (± 5 years, maximum difference 10 years), sex and mode of mechanical ventilation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The propolis mouthwash is used in intervention group and the chlorhexidine mouthwash is used in the control group. Propolis mouthwash (A) and chlorhexidine mouthwash (B) defined and blind available to the nurse. Also the data analyst is blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical sciences
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SEMUMS.REC.1397.208
Health conditions studied
1
Description of health condition studied
Ventilator-Associated Pneumonia
ICD-10 code
J95.851
ICD-10 code description
J95.851 Postprocedural respiratory disorders, not elsewhere classified
Primary outcomes
1
Description
Ventilator-Associated Pneumonia
Timepoint
1th; 3th; 5th and 7th days
Method of measurement
The assessment tool of ventilator-associated pneumonia modified clinical pulmonary infection score, which according to the body temperature, the white blood cell count, tracheal secretions, Ratio of arterial oxygen pressure (Pao2) to inspired oxygen fraction (Fio2) and chest x ray diagnose pneumonia.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, mouthwash by using Propolis solution, each containing 3 mg of propolis in 1 ml, are doing twice a day in 8 am and 4 pm for 7 days.
Category
Prevention
2
Description
Control group: In the control group, mouthwash using Chlorhexidine 0.2% solution, twice a day in 8 am and 4 pm for 7 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein (AS) and Bahar hospitals in Shahroud
Full name of responsible person
Monir Nobahar
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
Nobahar43@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3345 1336
Fax
+98 23 3365 4209
Email
P_kokha@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
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nobahar43@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nobahar43@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Monir Nobahar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4190
Email
nobahar43@semums.ac.ir
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
Data is confidential
Study Protocol
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data is confidential
When the data will become available and for how long
It was possible to publish the paper from the study.
To whom data/document is available
Research group
Under which criteria data/document could be used
After publishing the resulting paper, it can be made available to others
in order to use the results of the study.
From where data/document is obtainable
An article published in an valid journal among available journals
What processes are involved for a request to access data/document
The process of publishing an article in the journal