Protocol summary

Summary
This experimental study will be done to determine the effect of pressure ulcer care educational program on the intensive care units nurses’ performance in risk factor diagnosis, prevention and care of pressure ulcers in patients. Inclusion criteria: nurses with bachelor's degree and higher who work full-time in the intensive care unit and exclusion criteria: Nurses who are not responsible for the care of the patient with a pressure ulcer. The sample size is 70, and the sampling method is two-stage, including quotas sampling and random allocation. The first stage, according to the nurses' population in the trauma and internal care units, is considered to be a quota. In the second stage, with random allocation of intensive care units, 35 individuals are placed in the intervention group and 35 in the control group. The research tool consists of a researcher-made checklist that in the first stage, the checklist is completed by examining the performance of nurses in two intervention and control groups. The second stage is performed the program of training for the management of pressure ulcer in the form of learning workshop and providing educational Leaflet and CD for nurses in the intervention group. In the final stage, two weeks after the implementation of the pressure ulcer care program, the researcher examines the performance of nurses in the intervention and control groups to complete the checklist. Nurses’ performance is compared between the intervention and control groups before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080935602N1
Registration date: 2017-10-19, 1396/07/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-10-19, 1396/07/27
Registrant information
Name
Masomeh Sardari
Name of organization / entity
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
sardarim@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-02-06, 1396/11/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pressure ulcer management educational program on the performance of nurses in the care of patients admitted to the intensive care unit.
Public title
The effect of pressure ulser management training on nurses' performance
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Nurses with a bachelor's degree or higher who work full-time in the intensive care unit; Nurses who take care of inactive or Low mobility patients in intensive care units; Nurses who have at least one year of work experience at the ICU; Nurses who have not participated in the pressure ulcer training course during the past 6 months or are not passing this period. Exclusion criteria: Nurses who are not responsible for the care of the patient with a pressure ulcer.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, next to Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Avenue, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2017-01-03, 1395/10/14
Ethics committee reference number
IR.SBMU.PHNM.1395.583

Health conditions studied

1

Description of health condition studied
Pressure ulser
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area

Primary outcomes

1

Description
Nurses performance
Timepoint
Before and two weeks after the intervention
Method of measurement
Researcher chekList

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: a pressure ulcer care program through a workshop will be held for nurses in groups of 9 people for in three 90-minute training sessions during 3 weeks. In the first training course that will be held in the first week, 90 minutes of educational content related to skin Recognizing, assessment and determination of pressure ulcer risk factors will be provided for nurses. In the second training course, which will be held in the second week, pressure ulcer preventive measures will be taught in a 90 minute session. The third course will be held in the third week to provide educational content related to care and treatment measures of pressure ulcers. Educational leaflet and CD are also provided to the nurses.
Category
Behavior

2

Description
Control group: There is no action in the control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Ali Shariati Hospital
Full name of responsible person
Dr Roghaye Esmaieli
Street address
Dr. Ali Shariati Hospital, Between Mohammad Shahr Road and Mahdasht, Karaj
City
Tehran

2

Recruitment center
Name of recruitment center
Madani Hospital
Full name of responsible person
Dr Roghaye Esmaieli
Street address
Madani Hospital, at the end of the Mahan Street, Taleghani crossroads, Karaj
City
Tehran

3

Recruitment center
Name of recruitment center
Shahid Rajai Haspital
Full name of responsible person
Dr. Roghaye Esmaieli
Street address
Shahid Rajai Haspital, Shahid Rajai Street, Hesarak, karaj
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahib Beheshti University of Medical Sciences, next to Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen street, Shahid Chamran Highway
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 Shahid Beheshti 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
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masomeh Sardari
Position
M.S. Student in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, Across from Shahid Rajaee Hospital, Niayesh Intersection, Valiasr street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
sardari_4229@yahoo.com; sardarim@sbmu.ac.ir
Web page address
nm.sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Roghaye Esmaieli
Position
Assistant Professor in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, Across from Shahid Rajaee Hospital, Niayesh Intersection, Valiasr street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
r.esmaieli@sbmu.ac.ir; r_esmaieli@yahoo.com
Web page address
nm.sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Roghaye Esmaieli
Position
Assistant Professor in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, Across from Shahid Rajaee Hospital, Niayesh Intersection, Valiasr street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2521
Email
r.esmaieli@sbmu.ac.ir; r_esmaieli@yahoo.com
Web page address
nm.sbmu.ac.ir

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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