The purpose of this study was to evaluate the effect of comprehensive oral care on oral health changes compared with routine care in patients with an endotracheal tube is hospitalized in intensive care units . This study is a randomized , double- blind clinical trial with a sample size of 38 patients hospitalized in intensive care , tracheal tube , with sampling ( random allocation ) will be.electric toothbrushes , 1 minute brushing the tongue with a toothbrush, tongue, mouth and lips on each patient 's use Mrzvb .is evaluated . Data is collected and analyzed .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311107821N7
Registration date:2014-04-16, 1393/01/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-16, 1393/01/27
Registrant information
Name
Leila Mahasti Jouybari
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1443 0360
Email address
jouybari@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Sciences, Vice Chancellor for Research and Technology, Gorgan, Iran
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-06-19, 1393/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a comprehensive oral care on oral health changes in patients intubatedpatients in the intensive carehealth centersin Gorganin Gorgan
Public title
Comprehensive Oral Care On Oral Health Changes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients admitted to the intensive care unit with the endotracheal tube ; aged 18-65 years ; admitted less than 12 hours ; in the absence of coagulopathy ; no pregnancy ; no broken bones facial injuries and fractures of the neck is not fixed ; no injuries oral cavity and gum disease ; patients on admission are no suffering from diseases of the oral cavity of edentulous patients ; not receiving immune suppressor drugs.
Exclusion criteria: extubation before 24 hours ; not wanting to continue the study of the patient's legal family.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Golestan University of Medical sciences
Street address
Golestan University of medical sciences,Shastkola
City
Gorgan
Postal code
49165-568
Approval date
2013-12-08, 1392/09/17
Ethics committee reference number
26109209174
2
Ethics committee
Name of ethics committee
Ethical Committee Golestan University of Medical Sciences
Street address
Golestan University of Medical Sciences,Shastkola
City
Gorgan
Postal code
4934174515
Approval date
2013-12-08, 1392/09/17
Ethics committee reference number
26109209174
Health conditions studied
1
Description of health condition studied
Dental hygiene
ICD-10 code
K08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease
Primary outcomes
1
Description
oral health
Timepoint
Arrival, 48 and 72 hours after
Method of measurement
Oral health assessment tool
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group consisted of 19 patients in addition to routine care twice daily at 8 am and 8 pm under the comprehensive oral care. 'To take care 2 minutes brushing the electric toothbrushes; 1 minute brushing the tongue with a tongue scraping ,and using a mouth and lips moisturizer of every patient,
Category
Treatment - Drugs
2
Description
The control group consisted of 19 patients, only part of routine care, including rinsing with chlorhexidine swab is associated gas will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5th Azar Hospital
Full name of responsible person
Mojtaba Momeni
Street address
5 AZAR Hospitan ,5 AZAR Street
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research & Technology, Golestan University of Medical Sciences
Full name of responsible person
Dr. Mohamad Jafar Golalipour
Street address
Deputy of Research & Technology, Golestan University of Medical Sciences,Shastkola
City
Gorgan
Grant name
مرکز تحقیقات
Grant code / Reference number
مرکز تحقیقات
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research & Technology, Golestan 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
Golestan University of Medical Sciences
Full name of responsible person
Mojtaba Momeni
Position
Ms Student of Critical Nursing Care
Other areas of specialty/work
Street address
Bouyeh School of Nursing & Midwifery, Golestan University of Medical Sciences. Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 53 2388 3244
Fax
+98 17 1442 5171
Email
momenim28@yahoo.com
Web page address
www.goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Leila M Jouybari
Position
PhD, Dean of Nursing Rsearch Center
Other areas of specialty/work
Street address
Golestan University of Medical Sciences .Shastkola
City
Gorgan
Postal code
49165568
Phone
+1 714430360
Fax
+98 17 1442 5171
Email
Jouybari@gmail.comJouybari@goums.ac.ir
Web page address
http://jouybari.info
Person responsible for updating data
Contact
Name of organization / entity
Nursing Research Center, Golestan University of Medical Sciences
Full name of responsible person
Dr. Leila M Jouybari
Position
PhD of NUrsing Education, Dean of NUrsing Research Center
Other areas of specialty/work
Street address
Nursing Research Center ,Golestan University of Medical Sciences,Shastkola
City
Gorgan
Postal code
49165568
Phone
+98 17 1443 0360
Fax
+98 17 1442 5171
Email
jouybari@goums.ac.ir
Web page address
www.goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)