Protocol summary

Study aim
Determining the effect of training on nurses' performance in endotracheal suction of patients in intensive care units
Design
A randomized, one-blind clinical trial with 56 nurses participating randomly divided into two groups. In order to randomize, 28 yellow cards and 28 red card pockets will be used in the matte bag. By a conventional yellow color belongs to the case group and The red card belongs to the control group.
Settings and conduct
One-blind clinical trial in the intensive care unit of Imam Khomeini Hospital in Ardabil, that the analyst does not know about the classification of nurses in two groups.By randomization to control and case groups, the evaluation of the suction performance will be done using an observation checklist before and after the intervention.The intervention in the case group is the training of the principles of suction correctness and the results of the suction performance in the two groups will be compared before and after the intervention.
Participants/Inclusion and exclusion criteria
Not having acute and chronic illnesses Having a bachelor's degree and higher education Employment in the intensive care unit full time at least 3 months Provide direct patient care Interested in participating in the study Possibility to participate in training classes; Not having a willingness to participate during the study Not having possibility to participate in training classes during the study.
Intervention groups
Intervention by teaching the principles of suction as a lecture and presenting educational films and educational pamphlets , conducted by the supervisor of the training center during a 2-hour session within a week will be presented.The validity of the educational content was approved before being used by ten faculty members.
Main outcome variables
Suction performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181222042075N1
Registration date: 2019-01-06, 1397/10/16
Registration timing: registered_while_recruiting

Last update: 2019-01-06, 1397/10/16
Update count: 0
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Fateme Mohammadimegdar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 7620
Email address
mohammadimegdar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of training to the nurses' performance in endotracheal suctioning in patients of intensive care unit
Public title
Assessment of the effect of training to the nurses' performance
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Not having acute and chronic illnesses Having a bachelor's degree and higher education Employment in the intensive care unit full time at least 3 months Provide direct patient care Interested in participating in the study Possibility to participate in training classes
Exclusion criteria:
Not having a willingness to participate during the study Not having possibility to participate in training classes during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization Random unit: Individual Randomization Tool:The number is equal to 28 yellow cards and 28 red cards in a matte bag. Then, the sample units of the research (nurses) will be required to remove one of the cards from the inside of the bag, in a conventional yellow color belonging to the case group red card group belonging to The control group will be. To hide: Participants will not be able to see the cards in the matte bag.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst does not know that the results before and after the intervention are for which case or control group.
Placebo
Not used
Assignment
Other
Other design features
A clinical trial study with nurses participating in the intensive care unit randomly divided into two groups.The control and evaluation of the suction performance during the procedure will be done using an observational checklist before and after the intervention. Intervention in the case group is the training of the principles Correct suctioning and the results of suction performance in both groups will be compared before and after the intervention.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Imam Reza Hospital, Basij Square, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619836468
Approval date
2018-12-04, 1397/09/13
Ethics committee reference number
IR.ARUMS.REC.1397.144

Health conditions studied

1

Description of health condition studied
Training, suction performance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nursing suction performance, rating of the Check list suction performance
Timepoint
Before the intervention and one month after the intervention
Method of measurement
observational checklist of suction performance

Secondary outcomes

1

Description
Diagnosis of clinical indication of need for suction, presence or absence of clinical indication of need for suction
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Observational checklist clinical indication of need for suction

Intervention groups

1

Description
Intervention group: Intervention by teaching the principles of suction as a lecture and presenting educational films and educational pamphlets prepared by the researcher based on the nursing care standards of the country, conducted by the supervisor of the training center during a 2-hour session within a week (due to the shift of the nurses participating in The study) will be provided. The contents of the training were put before the use of 10 faculty members. Then the content validity was determined using the Walters and Basel techniques.
Category
N/A

2

Description
Control group: Additional work will not be done for this group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini therapeutic- training center
Full name of responsible person
Dr. Ismail Farzaneh
Street address
Imam Khomeini, Hospital, Noiagdam Street, Gods Square
City
Ardabil
Province
Ardabil
Postal code
5619647531
Phone
+98 45 3325 1401
Fax
Email
Emamhe@arums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Shahab Bohloli
Street address
Ardabil University of Medical Sciences, University Square, End of University Street
City
Ardabil
Province
Ardabil
Postal code
85991-56189
Phone
+98 45 3352 2247
Email
info@arums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Fateme Mohammadimegdar
Position
Head Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital., Basij Square., Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5619836468
Phone
+98 45 3351 7620
Fax
Email
mohammadimegdar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Fateme Mohammadimegdar
Position
Head Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital., Basij Square., Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5619836468
Phone
+98 45 3351 7620
Fax
Email
mohammadimegdar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Fateme Mohammadimegdar
Position
Head Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital., Basij Square., Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5619836468
Phone
+98 45 3351 7620
Fax
Email
mohammadimegdar@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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