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Effect of electronic education of clinical management of substance dependent pregnant women during labor and postpartum on knowledge and clinical skill performance of physicians

Protocol summary

Study aim
comparison the mean score of knowledge and clinical performance of physicians before,immediately and one month after the end of the e-education of clinical management of substance dependent pregnant women during labor and postpartum in intervention and control group
Design
Experimental parallel group randomized study with intervention and control group
Settings and conduct
Sampling from physicians working in delivery rooms and dividing them into control and intervention groups using permuted block randomization.First, knowledge and clinical performance assessment in control group,3weeks later,doing posttest and one month later doing retention test.Simultaneously with retention tests in control group,doing pretest in the intervention group.Then starting the e-learning education during 3weeks via LMS.Doing posttest and retention test,Immediately after intervention and one month after that
Participants/Inclusion and exclusion criteria
Inclusion criteria: G.P degree,work in Maternity Hospitals,Researcher access to samples,complete informed consent form,Having Internet access,Have at least information for work with computer,No participation in training courses related with research title before.Exclusion criteria:Unwillingness to continue study,Participate in other classes related to research during the study,Failure to complete one content of e-learning
Intervention groups
Participation in 1hour training session and nine 40minute e-learning sessions for 3weeks in intervention group.Answering to15to20 multiple choice questions to better understand the content at the end of each training session.Doing pretest,posttest and retention test of knowledge and clinical performance,Before,immediately after intervention and one month after
Main outcome variables
Improvement of knowledge and clinical performance in clinical management of substance-dependent pregnant women during labor and postpartum

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180928041164N2
Registration date: 2018-11-15, 1397/08/24
Registration timing: prospective

Last update: 2018-11-15, 1397/08/24
Update count: 0
Registration date
2018-11-15, 1397/08/24
Registrant information
Name
hasti heidarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3271 8170
Email address
stud3240914115@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of electronic education of clinical management of substance dependent pregnant women during labor and postpartum on knowledge and clinical skill performance of physicians
Public title
Effect of electronic education of clinical management pregnant women during labor and postpartum on knowledge and clinical performance
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least a Professional Ph.D degree Employment in Governmental Maternity Hospitals Affiliated to Shiraz University of Medical Sciences in Shiraz Researcher access to samples during the study period (For example, not having the intent of samples for unpaid or long-term leave) Satisfaction to participate in the study and complete the informed written consent form Having Internet access Having Internet access. Have at least information for working with the computer to enter LMS Not participation in training courses associated with research title before starting the research.
Exclusion criteria:
Unwillingness to continue to participate in research Participate in other classes related to research title during the study period Failure to study at least one of the content of e-learning in this study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Random units are physicians, and the method is based on permuted random allocation. Using random block method and block size 4, and using the Random Allocation software has been developed by M. Saghaei) With a block size of four and twenty- five blocks (A total of 100 samples) A random list is generated And based on that list, Quadrilateral Blocks Combined, ABBA, BAAB, BABA, ABAB, BBAA, AABB Are produced And based on the combination obtained from 25 blocks. Accordingly, midwives are assigned to the intervention and control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, in order to prevent the information leakage from the intervention group to the control group and not to alter the results of the study, at first, the pre-test and post-test of knowledge and clinical skills will be done in the control group, one month after posttest, knowledge and clinical retention test will be done and simultaneously with retention test in the control group, the pre-test will be performed in the intervention group and will be subjected to e-learning. Immediately after completing e-learning and one month after that, a post-test and retention test of knowledge and clinical skills will be taken from the intervention group. At the end of the study, the educational content is also available to the control group. Additionally, physicians who have completed the course with completion of the pre-test and post-test, and have at least a retraining score, will be awarded a Continuous Medical Education (CME).

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethic committee of Shiraz University of Medical Sciences
Street address
Flat 7, Shiraz University of Medical Sciences Building, Zand Blv
City
Shiraz
Province
Fars
Postal code
7193613119
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
IR.SUMS.REC.1397.408

Health conditions studied

1

Description of health condition studied
Clinical management of substance dependent pregnant women during labor and postpartum
ICD-10 code
O99.3
ICD-10 code description
Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium

Primary outcomes

1

Description
Physicians Knowledge regarding Clinical management of substance dependent mothers during labor and post-partum period
Timepoint
Before the intervention, immediately after the end of the intervention
Method of measurement
A researcher-made questionnaire for measuring knowledge has 38 multiple choice questions

2

Description
Physicians clinical performance on Clinical management of substance dependent mothers during labor and post-partum period
Timepoint
Before the intervention, immediately after the end of the intervention
Method of measurement
Objective Structured Clinical Exam (OSCE), made up of 5 stations

Secondary outcomes

1

Description
Knowledge Retention regarding on Clinical management of substance dependent mothers during labor and post-partum period
Timepoint
One month after intervention
Method of measurement
Researcher made questionnaire for knowledge assessment with 38 multiple choice questions

2

Description
Clinical performance Retention regarding Clinical management of substance dependent mothers during labor and post-partum period
Timepoint
One month after intervention
Method of measurement
Researcher made questionnaire for knowledge assessment with 38 multiple choice questions

Intervention groups

1

Description
Intervention group: At first, a pre-test of knowledge and clinical performance will be performed from the intervention group, Then, the user code and password are provided for the samples to enter the Learning Management System (LMS). The intervention group will be trained for 3 weeks by 1 session of 1hour face to face and nine 40-minutes sessions of e-learning.
Category
N/A

2

Description
Control group: In the control group, without any intervention, three timed knowledge questionnaire and clinical performance using OSCE will be done.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Delivery room of Hazrat Zeynab Hospital in Shiraz
Full name of responsible person
Hasti Heidarain
Street address
Defa moghadas Crossroad
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3627 1531
Email
zeinabhp@sums.ac.ir

2

Recruitment center
Name of recruitment center
Delivery room of Shoushtari Mother and Child Hospital in Shiraz
Full name of responsible person
Hasti Heidarain
Street address
Nader ave
City
Shiraz
Province
Fars
Postal code
7173775617
Phone
+98 71 3232 4811
Email
shoushtari@sums.ac.ir

3

Recruitment center
Name of recruitment center
Delivery room of Shahid Beheshti Hospital in Shiraz
Full name of responsible person
Hasti Heidarain
Street address
Zeinabiyeh Blv
City
Shiraz
Province
Fars
Postal code
7136816695
Phone
+98 71 3223 1499
Email
shoushtari@sums.ac.ir

4

Recruitment center
Name of recruitment center
Delivery room of Hafez Hospital in Shiraz
Full name of responsible person
Hasti Heidarain
Street address
Chamran Blv
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3627 1531
Email
hafezhospt@sums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Flat 7, research deputy, Shiraz University of Medical Sciences, Zand Blv, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hasti Heidarian
Position
Msc student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 42 5536 4771
Email
hastiheidarian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Roksana Janghorban
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery Shiraz, Namazi Square, Zand Blv.
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
janghorban@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hasti Heidarian
Position
Msc student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Namazi Square, Zand Street, Fatemeh School of Nursing and Midwifery Shiraz
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
hastiheidarian@gmail.com

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
There is not more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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