Protocol summary

Study aim
Investigating the Effect of Competency-based Education in Emergency Obstetric Care on the Learning, Behavior and Reaction of Midwifery Students based on Kirkpatrick's Evaluation Model
Design
Semi-experimental educational experiment with control group is community-based and the sampling method is convenience. Using table of random numbers, all registered individuals are placed into the intervention and control groups in a parallel way. The sample size in each group regarding the loss is 44.
Settings and conduct
Emergency Obstetric Care education will be conducted at the Center for Clinical Skills in Iran Faculty of Nursing and Midwifery. Training sessions are 4 sessions and 5 hours per day.
Participants/Inclusion and exclusion criteria
Entry requirements: 1)Associate degree midwifery students enrolled in 4th semester in Iran Faculty of Nursing and Midwifery 2)Bachelor degree midwifery students enrolled in 4th and 6th semester in Iran Faculty of Nursing and Midwifery 3)No practical experience as job in the hospitals except their internship
Intervention groups
Emergency Obstetric Care education will be provided to the intervention group; before the intervention, knowledge, skills, and confidence level will be assessed in the intervention group; education is in four training sessions, five hours per day. At the end of the intervention, the assessment of knowledge, skills, and level of confidence takes place immediately and then six weeks later. In control , apart from the assessment, in terms of knowledge, skill, and level of confidence, with 6 weeks interval , All training leaflets and PowerPoint presentations will be provided to the control group along with a checklist of skills at the end of the work.
Main outcome variables
Differences in the level of learning, behavior and reaction of students before, immediately and 6 weeks after intervention in intervention and control groups

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180609040017N1
Registration date: 2018-07-11, 1397/04/20
Registration timing: registered_while_recruiting

Last update: 2018-07-11, 1397/04/20
Update count: 0
Registration date
2018-07-11, 1397/04/20
Registrant information
Name
Masumah Hakimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3256 7624
Email address
Hakimi.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-17, 1397/03/27
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Competency Based Training in the Field of Emergency Obstetric Care on the Learning, Behavior and Reaction of Midwifery Students Based on Kirkpatrick `s Evaluation Model
Public title
Investigating the Effect of Competency Based Education in Emergency Obstetric Care on the Learning, Behavior and Reaction
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
midwifery students in Associate‘s degree in Iran Faculty of Nursing and Midwifery, 4th semester midwifery students in Bachelor‘s degree in Iran Faculty of Nursing and Midwifery, 4th and 6th semester no practical experience as job in hospital except internship
Exclusion criteria:
Not attending 1 training session
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
Randomization (investigator's opinion)
Randomized
Randomization description
All students interested in participating in the course by using the random numbers table divided in two groups of intervention and control.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-06-02, 1397/03/12
Ethics committee reference number
IR.IUMS.REC.1397.026

Health conditions studied

1

Description of health condition studied
Investigating the effect of competency-based education in the field of emergency obstetric care on the learning, behavior and reaction of midwifery students
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reaction Score
Timepoint
immediately after the end of the educational course
Method of measurement
Education Effectiveness Evaluation Questionnaire (Based on Kirk Patrick Model)

2

Description
Knowledge score
Timepoint
before intervention, immediately and 6 weeks after the intervention
Method of measurement
Knowledge Questionnaire in Emergency Obstetric Care Education

3

Description
Level of confidence in Emergency Obstetric Care skills
Timepoint
before, immediately and 6 weeks after intervention
Method of measurement
confidence questionnaire on maternal and neonatal health skills

4

Description
students' skill level in the field of Emergency Obstetric Care
Timepoint
before, immediately and 6 weeks after intervention
Method of measurement
Emergency Obstetric Care Skill's checklists

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Emergency Obstetric Care education in 4 sessions,each session 5 hours in the field of dystocia, shock, neonatal resuscitation and postpartum hemorrhage.
Category
Other

2

Description
Control group: Assessment of knowledge, skills, and confidence level with a 6-week interval. Provide tutorials and PowerPoints after the end of the intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Faculty of Nursing and Midwifery
Full name of responsible person
Masumah Hakimi
Street address
No. 222, Shahid Shafei 30 Ave., Golshahr, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9156967179
Phone
+98 51 3256 7624
Email
hakimi.m@tak.iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Kazem Malakooti
Street address
Medical Sciences of Iran, Hemmat Highway, next to Milad Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9024
Email
kmalakouti@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Masumah Hakimi
Position
Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No.222, Shahid Shafiee 30, Golshahr, Mashhad Town
City
Kabul
Province
Kabul
Postal code
9156967179
Phone
+98 51 3256 7624
Email
hakimi.m@tak.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masoomeh Kheikhah
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Iran Faculty of Nursing and Midwifery, Rashid yasemi Ave. Vanak Square, Tehran
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1000
Email
shivakheirkhah1345@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Masumah Hakimi
Position
Midwifery Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
No. 222, Shahid Shafiei St., Golshahr, Mashhad Town
City
Kabul
Province
Kabul
Postal code
9156967179
Phone
+98 51 3256 7624
Email
hakimi.m@tak.iums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Students' personal information and their names will not be published based on informed consent and ethical codes.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
The thesis will be available to individuals after approval and defense, which includes the process of work and the statistical and specific results. Participants information will be protected.
When the data will become available and for how long
After 2019
To whom data/document is available
All scholars and students in the private and public sectors
Under which criteria data/document could be used
For use in research and education at universities
From where data/document is obtainable
Dr. Masoomeh Kheirkhah, address: Tehran, above Vanak Square, Rashid Yasemi St., Faculty of Nursing Midwifery, shivakheirkhah1345@gmail.com Masoumeh Hakimi, post address: Tehran, above Vanak Square, Rashid Yasemi Ave., Faculty of Nursing Midwifery, masumah.hakimi@gmail.com
What processes are involved for a request to access data/document
Request is sufficient by using an official email.
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