Protocol summary

Summary
Objective: To identify the effect of educational program on nurses performance in care of neonate with peripheraly inserted central catheter. Design : It is a non randomized controlled clinical trial.80 nurses working in NICU of the training hospitals affiliated to Tehran and Iran Medical Science University are chosen and devided to control ( n=40) and intervention (n=40) groups. Inclusion criterias are undergraduated and higher education; at least three months experience in NICU; having direct clinical works. Exclusion criteria is absence in more than one training session. Setting: A two part questionnaire is prepared to assess nurse's performance. This questionnaire is consist of demographic information and a standard checklist regarding to care of peripherally inserted central catheter that has been approved by 10 members of academic staff. By using this checklist nurse's performance is measured before education intervention in both groups.Assessment done three times in different shifts and average of three points is total score, then educational intervention will be done and after one month, nursing performance in intervention group will be evaluated with the same checklist in three times in different shifts and control group again will be evaluated without educational intervention.In this way effect of educational program will be assessed. Main outcome: It is expected that educational intervention can improve nurse's performance in care of peripherally inserted central catheter.

General information

Acronym
non
IRCT registration information
IRCT registration number: IRCT2017012831260N1
Registration date: 2017-03-22, 1396/01/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-03-22, 1396/01/02
Registrant information
Name
Somayeh Emamgholi
Name of organization / entity
School of Nursing and Midwifery, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 7648
Email address
emamgholi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program on nurses performance in care of neonates with peripherally inserted central catheter
Public title
The effect of educational program on nurses performance in care of neonates with peripherally inserted central catheter
Purpose
Other
Inclusion/Exclusion criteria
Inclusin Criteria:undergradutated and higher education; At least three month experience in NICU; having direct clinical work; Having a mobile phone Exclusion criteria: Absence in more than one training session
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
non

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
School of Nursing and Midwifery, Shahid Yasamy Street- Valiasr AVE
City
Tehran
Postal code
1996713883
Approval date
2016-06-29, 1395/04/09
Ethics committee reference number
IR.IUMS.REC 1395.9211451204

Health conditions studied

1

Description of health condition studied
Nurse's performance about care of peripherally inserted central catheter in neonates
ICD-10 code
_
ICD-10 code description
_

Primary outcomes

1

Description
Nursing performance about care of peripherally inserted central catheter in neonates
Timepoint
Before intervention and then 1 month after educational intervention
Method of measurement
Researcher's structured check list

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After explain necessary details about project to participants and take their cooperation and obtain consent from nurses and remember them that they can leave research in any time,performance of each nurse about checklist's items will be observed in three phases in different shifts.Criteria response to checklist will be yes or no.In each phase if nurse performs the correct procedure she/he receives 1 point and if performs incorrect procedure, receives 0 point. So each item will be 0-3 points, average of this three points will be total score.Then educational intervention will be done.Educational program that, it's content is according to valid clinical guideline about care of peripherally inserted central line catheter and content of questionnaire has been approved by 10 members of academic staff. After approving of scientific content, program will be done in form of small group education. Educational sessions will be in 4 one- hour sessions. Training site will be in conference room of each ward. Educational sessions will be in form of educator presentation, group discussion, power point presentation and film screening. After the last session, education will be done in bedside by researcher about details of procedure, then educational package that include education content in form of booklet will be provide to wards. Also a poster about different steps of care of peripherally inserted central line catheter in neonate will be installed in place of the ward that is visible to the nurses. After one month, nurse's performanc in intervention group will be evaluated by researcher in three phases and different shifts with observational checklist.
Category
Other

2

Description
Control group: After explain necessary details about project to participants and take their cooperation and obtain consent from nurses and remember them that they can leave research in any time,performance of each nurse about checklist's items will be observed in three phases in different shifts.Criteria response to checklist will be yes or no.In each phase if nurse perform the correct procedure she/he receives 1 point and if performs incorrect procedure, receives 0 point. So each item will be 0-3 points, average of this three points will be total score. In this stage no intervention will be done for control group. After one month of educational intervention in intervention group, also control group will be evaluated with checklist and finally in terms of ethical principles all of educational contents include poster,booklet, pamphlet and etc will be provided to nurses in control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Center of Children Medical Hospital
Full name of responsible person
Somayeh Emamgholi
Street address
Center of Children Medical Hospital, Dr.Mohammad Gharib Street,Keshavarz blvd
City
Tehran

2

Recruitment center
Name of recruitment center
Arash Hospital
Full name of responsible person
Somayeh Emamgholi
Street address
Farjam Street, Tehranpars third Sq.
City
Tehran

3

Recruitment center
Name of recruitment center
Rasul Hospital
Full name of responsible person
Somayeh Emamgholi
Street address
Rasul Hospital, Sattarkhan Street, Niayesh Street
City
Tehran

4

Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Somayeh Emamgholi
Street address
Ali Asghar Hospital, Vahid Dastjerdi Street, North Modarres Highway .
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Iran University of Medical Sciences.
Full name of responsible person
Dr.Sedighe Khanjari
Street address
School of Nursing and Midwifery, Shahid yasami Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Iran 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
Iran University, School of Nursing and Midwifery
Full name of responsible person
Somaye Emamgholi
Position
NICU Nursing Master student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Yasami Street
City
Tehran
Postal code
_
Phone
+98 21 8888 2885
Fax
_
Email
Emamgholisomaye@yahoo.com Emamgholi_s@iums.ac.ir
Web page address
_

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Sedighe Khanjari
Position
Nursing PhD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid yasami Street, Valiasr AVE.
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
_
Email
Sed.khanjari@gmail.com
Web page address
_

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences, Nursing and Midwifery School
Full name of responsible person
Somayeh Emamgholi
Position
NICU Nursing Master Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Yasamy Street.
City
Tehran
Postal code
_
Phone
+98 21 8888 2885
Fax
_
Email
Emamgholisomaye@yahoo.com Emamgholi_s@iums.ac.ir
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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