Determining the effect of educational intervention based on Social Cognitive Theory on marital burnout in pregnant women
Design
87 pregnant women were randomly assigned to parallel intervention and control groups and participants are given a code. The intervention is conducted in 4 sessions of 90 minutes for the intervention group.
Settings and conduct
Place of intervention is Gonabad city health centers. The intervention group is trained based on social cognitive theory and the control group does not receive any training and they are evaluated with a questionnaire after two months.
Participants/Inclusion and exclusion criteria
Entry requirements: pregnant women aged 45 to 15 years old; satisfaction to participate in the study; having at least elementary education.
Exit criteria: gestational age more than 30 weeks; cancel continued cooperation; absence more than once in educational sessions; acute or chronic mental illness.
Intervention groups
The intervention group consisted of 87 pregnant women in two groups of 43 exams and 44 controls.The intervention group provides training based on the effective structures of social cognitive theory, while the control group only receives routine health care.
Main outcome variables
Marital burnout pregnant women
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160917029843N6
Registration date:2018-05-29, 1397/03/08
Registration timing:retrospective
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Mohammad Vahedian-Shahroodi
Name of organization / entity
Social Determinants of Health Research Center, Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3189 2202
Email address
vahedianm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-29, 1396/08/07
Expected recruitment end date
2017-12-28, 1396/10/07
Actual recruitment start date
2017-10-29, 1396/08/07
Actual recruitment end date
2017-12-28, 1396/10/07
Trial completion date
empty
Scientific title
Effect of educational intervention based on social cognitive theory on marital burnout in pregnant women
Public title
The impact of education on marital burnout pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant women aged 45 to 15 years old
Having at least basic literacy
Have desire and cooperation to participate in the research
Exclusion criteria:
Having acute or chronic mental disorders
Unwillingness to continue cooperation
Absence more than once in training sessions
Gestational age more than 30 weeks
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Using a random number table
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 Mashhad University of Medical Sciences
Street address
University 18 Ave., School of Public Health
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2016-11-12, 1395/08/22
Ethics committee reference number
IR.MUMS.REC.1395.407
Health conditions studied
1
Description of health condition studied
Marital Burnout pregnant women
ICD-10 code
Z34.0
ICD-10 code description
Encounter for supervision of normal first pregnancy
Primary outcomes
1
Description
Marital Burnout pregnant women
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Marital Burnout Questionnaire(CBM)
Secondary outcomes
1
Description
knowledge
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
2
Description
Expect the outcome
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
3
Description
The value of the outcome
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
4
Description
Self efficacy
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
5
Description
Self-efficacy overcoming obstacles
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
6
Description
Availability
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
7
Description
Social support
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
8
Description
Observational learning
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
9
Description
Skill
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
10
Description
Understand the situation
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
11
Description
Self-regulatory
Timepoint
Before intervention, immediately after intervention, 2 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: the intervention group includes 43 pregnant women.In addition to routine care, training is provided over four 90-minute sessions based on the more effective structures of social cognitive theory.
Category
Behavior
2
Description
Control group: the control group has 44 pregnant women who only receive routine care at the health centers.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Gonabad city health centers
Full name of responsible person
Mahin Moravejjifar
Street address
Gonabad, Asian Roads, Gonabad University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9415645745
Phone
+98 58 3241 8507
Email
vahedianm@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
University 18 Ave., School of Public Health
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 3007
Email
vahedianm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Vahedian Shahroodi
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University 18 Ave., School of Public Health
City
mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3854 4833
Fax
+98 51 3852 2775
Email
vahedianm@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Vahedian Shahroodi
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University 18 Ave., School of Public Health
City
Mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+98 51 3854 4833
Email
vahedianm@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammad Vahedian Shahroodi
Position
Assistant Professor of Health Education and Health Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
University 18 Ave., School of Public Health
City
mashhad
Province
Razavi Khorasan
Postal code
9137673119
Phone
+385 44633
Email
vahedianm@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Potential data can be shared only after identification
When the data will become available and for how long
Get started one month after the results are published.
To whom data/document is available
Researchers working in academia and academic
Under which criteria data/document could be used
The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the sender.
From where data/document is obtainable
Dr. Mohammad Vahedian-Shahroodi vahedianm@mums.ac.ir
What processes are involved for a request to access data/document
The data are sent by official request through academic or organizational emails of the researchers after confirmation and identification of the sender.