Protocol summary

Summary
Aim: Oral hygiene is important among patients who are admitted in intensive care units. It is one of main issues in nursing care. The purpose of this study was to compare the effects of mouthwash 2% Chlorhexidine and combination with oral suction on oral hygiene in intensive care unit patients. Materials and Methods: In a semi-experimental research design, the 90 patients who were admitted to the intensive care units, selected. inclusion criteria: patient admitted in icu; patient be intubated and patient be under mechanical ventilation. Exclusion criteria: patient have injury in lips and oral; patient have surgery in oral and tracheostomy. Patients randomly divided in two groups. In group one mouthwash with 2% Chlorhexidine applied and in the group two, 2% Chlorhexidine in combination with oral suction used. These procedures applied in 7 days. Oral hygiene status of patients assessed by using Beck checklist at the 1st and 7th days of admission in intensive care units. According to research aims data analysis is down.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012072310366N2
Registration date: 2012-12-18, 1391/09/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-12-18, 1391/09/28
Registrant information
Name
Maryam Tajadiny
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1223 5011
Email address
maryam.tajadiny@gmail.com
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Effects of Chlorhexidine Mouthwash and Combination with Oral Suction on Oral Hygiene in Critically Ill Patients
Public title
The Comparison Effects of Chlorhexidine Mouthwash and Combination with Oral Suction on Oral Hygiene in Critically Ill Patients
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: patient admitted in icu; patient be intubated and patient be under mechanical ventilation. Exclusion criteria: patient have injury in lips and oral; patient have surgery in oral and tracheostomy.
Age
From 7 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
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
kerman university of medical science
Street address
kerman . gomhory bolvard
City
kerman
Postal code
7618747653
Approval date
2012-11-10, 1391/08/20
Ethics committee reference number
k/91/216

Health conditions studied

1

Description of health condition studied
Oral health
ICD-10 code
K00-14
ICD-10 code description
Disorders of tooth development and eruption

Primary outcomes

1

Description
Oral health
Timepoint
First and seventh days
Method of measurement
Beck instrument

Secondary outcomes

empty

Intervention groups

1

Description
In group one mouthwash with 2% Chlorhexidine applied . These procedures applied in 7 days. Oral hygiene status of patients assessed by using Beck checklist at the 1st and 7th days of admission in intensive care units. According to research aims data analysis is down
Category
Prevention

2

Description
In the second group, 2% Chlorhexidine in combination with oral suction used. These procedures applied in 7 days. Oral hygiene status of patients assessed by using Beck checklist at the 1st and 7th days of admission in intensive care units. According to research aims data analysis is down
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Bahonar hospital
Full name of responsible person
Maryam Tajadiny
Street address
ICU 1, Bahonar hospital, Kerman
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Reza Malekpour Afshar
Street address
Kerman University of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Maryam Tajadiny
Position
Master of nursing
Other areas of specialty/work
Street address
Bahonar hospital, Kerman
City
Kerman
Postal code
7856133833
Phone
+98 34 1223 5011
Fax
+98 34 1223 5011
Email
MARYAM.TAJADINY@GMAIL.COM
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Tajadiny
Position
Master of nursing
Other areas of specialty/work
Street address
Bahonar hospital, Kerman
City
Kerman
Postal code
7856133833
Phone
+98 34 1223 5011
Fax
+98 34 1223 5011
Email
MARYAM.TAJADINY@GMAIL.COM
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Tajadiny
Position
Master of nursing
Other areas of specialty/work
Street address
Bahonar hospital, Kerman
City
Kerman
Postal code
7856133833
Phone
+98 34 1223 5011
Fax
+98 34 1223 5011
Email
maryam.tajadiny@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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