Comparison of group education with sending health messages and education through CD on knowledge, attitude and practice of male about participation in perinatal care
Determining and comparing the effect of two methods of group training with the sending of SMS messages and CD-ROM training on men's knowledge, attitude and practice about participation in perinatal care
Design
The clinical trial has two intervention groups and one control group, each group based on the lottery and randomly selected from a prenatal clinic. Sample size for each group of 22 and total was calculated to be 66. but considering the chance of sample loss, sample size was increased to 72.
Settings and conduct
The research environment is three prenatal clinics is affiliated Social Security Organization of Tabriz city, each group will be randomly selected from a center. Initially, through pregnancy care records, the list of pregnant women with a gestational age of 20 to 22 weeks was extracted and through Phone will be invited from their husband to participate in the research. Training for group education is conducted in two sessions 2-hours with a weekly interval on Fridays in rooms in the same centers, and then each week 3-4 health messages will be sent to them.
Participants/Inclusion and exclusion criteria
The inclusion criteria are Being litrate; not having passed any educational courses; living with spouse; There is no problem in the relationship between couples. The exclusion criteria are unwillingness to continue the study; and not participating in all the conducted educational sessions for the education group.
Intervention groups
The present study is a clinical trial which is conducted on three groups of group education with sending health messages , education using multimedia compact disk (CD) and control group.
Main outcome variables
Knowledge, attitude and practice in all three groups will be measured before and 3 months after intervention through researcher-made questionnaires.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160224026756N4
Registration date:2018-05-27, 1397/03/06
Registration timing:registered_while_recruiting
Last update:2018-05-27, 1397/03/06
Update count:0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
Mahnaz Noroozi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3441 1421
Email address
noroozi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of group education with sending health messages and education through CD on knowledge, attitude and practice of male about participation in perinatal care
Public title
Comparison of Two Methods of Education on Men Participation in perinatal care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy reading and writing
LIving with spouse
Exclusion criteria:
There is problem in the relationship between couples
Participation of men in any educational intervention or training course on participation in perinatal care
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Assign three clinics for two intervention groups (education with sending health messages and education through CD) and control group through the lottery. Samples will be selected based on convenience sampling in clinics.
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 Isfahan University of Medical Sciences
Street address
School of Nursing and Midwifery,Isfahan University of Medical Sciences, Hezar Jarib Street, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
IR.MUI.Rec.1395.3.599
Health conditions studied
1
Description of health condition studied
Men participation in perinatal care
ICD-10 code
094-099
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Knowledge
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Questionnaire
2
Description
Attitude
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Questionnaire
3
Description
Practice
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Group training with classroom training (groups of 8 people) will be conducted in two sessions of two hours a day, one week intervals on Fridays, and then three to four short messages will be sent each week to 3 months after the start of intervention.
Category
Other
2
Description
Intervention group 2: Training by CD
Category
Other
3
Description
Control group: No intervention will be received
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Prenatal Clinic, 29 Bahman Hospital
Full name of responsible person
Dr Lida Heidari
Street address
29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166617857
Phone
+98 41 3338 9342
Email
lh1373@yahoo.com5133
2
Recruitment center
Name of recruitment center
Shahid Mokhtari prenatal clinic
Full name of responsible person
Dr Amir Hossein Samimifar
Street address
Before of Monajem Blvd, Shams-e- Tabrizi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5139933356
Phone
+98 41 3266 2720
Email
vahidehfirouzan@yahoo.com
3
Recruitment center
Name of recruitment center
Shahid Malekpour Prenatal Clinic
Full name of responsible person
Mohammad Azimi
Street address
Saeb Street, lower than Masjid Station, Zaferanieh Town
City
Tabriz
Province
East Azarbaijan
Postal code
5166736868
Phone
+98 41 3330 9076
Email
vahidehfirouzan@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Shaghayegh Haghjouy Javanmard
Street address
Research & Technology Dept, Isfahan University of Medical Sciences, St Hezar Jarib, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
319-81745
Phone
+98 31 3668 8138
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
80
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
2
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Research Department,Third Floor, Central Construction Number 2, Tabriz University of Medical Sciences, Golghast Street, Azadi Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6969
Email
Research@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
20
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
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery,Isfahan University of medical sciences,St. thousand acres, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7532
Email
noroozi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahnaz Noroozi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery,Isfahan University of medical sciences,St. thousand acres, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7532
Email
noroozi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vahideh firouzan
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery,Isfahan University of medical sciences,St. thousand acres, Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7532
Email
vahidehfirouzan@yahoo.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
Data of participants are privacy
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The result of clinical study will be published as article
When the data will become available and for how long
Immediately after publishing the results.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific using with citation to article.
From where data/document is obtainable
Email: noroozi@nm.mui.ac.ir
What processes are involved for a request to access data/document
Maximum one week after the communication by email.