The effect of education based on health-promoting behaviors of pregnant women by social messenger application in the prevention of postpartum depression
Determining the effect of education based on health promoting behaviors of pregnant women in preventing postpartum depression using social messenger
Design
This study a clinical trial with a control group, with parallel groups, was conducted on 108 eligible pregnant women who referred to prenatal clinics of teaching hospitals in Babol. Participants were selected using convenience sampling with inclusion criteria. Then they were divided into two intervention or control groups according to the random block allocation protocol (generated by the random allocation software).
Settings and conduct
The prenatal clinics in teaching hospitals in Babol
Participants/Inclusion and exclusion criteria
Women with a gestational age of 28-30 weeks who meet the inclusion criteria and have given written informed consent to participate in this research.
Intervention groups
In the intervention group, in addition to receiving routin care, virtual training based on health-promoting behaviors was conducted weekly in the form of educational files (audio and text) during six sessions.
Control group: routine pregnancy care: they will receive routine training during pregnancy (trainings that are given to mothers face-to-face by health care workers during pregnancy care)
Main outcome variables
Primary outcome: depression based on the Edinburgh Questionnaire
Secondary outcome: depression based on patient health questionnaire and health promoting behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221109056451N2
Registration date:2024-05-31, 1403/03/11
Registration timing:retrospective
Last update:2024-05-31, 1403/03/11
Update count:0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Fatemeh Bakouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3232 2589
Email address
bakouei2004@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2023-02-19, 1401/11/30
Actual recruitment start date
2022-07-23, 1401/05/01
Actual recruitment end date
2023-04-14, 1402/01/25
Trial completion date
2023-04-14, 1402/01/25
Scientific title
The effect of education based on health-promoting behaviors of pregnant women by social messenger application in the prevention of postpartum depression
Public title
The effect of the health-promoting behaviors education in prevention of postpartum depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Gestational age 28-30 weeks
Ability to read and write
Having a smart mobile phone and the ability to communicate with social messengers
Having an Edinburgh depression score of less than 12
Willingness to participate in the study
Exclusion criteria:
No known chronic disease
Not having a history of depression or a history of hospitalization due to mental problems
Not having major mental problems and not taking psychiatric drugs according to the person's opinion
No addiction or habitual use of alcohol and drugs
Not having a history of infertility or using assisted reproductive methods
Not having special conditions in the current pregnancy such as cerclage, placenta privia, etc.
Not having an abnormal fetus or child
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
108
Actual sample size reached:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women will be allocated to one of the control and intervention groups using a random method with blocks of four in a one-to-one ratio, so that the researcher cannot predict which group the next person will be in. The random list will be prepared using Random Allocation Software.
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
Research Ethics Committees of Health Research Institute - Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afroz Ave, Babol
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Approval date
2022-07-11, 1401/04/20
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.094
Health conditions studied
1
Description of health condition studied
Postpartum depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression based on the Edinburgh Questionnaire
Timepoint
Before the intervention and six weeks after delivery
Method of measurement
Edinburgh depression questionnaire
Secondary outcomes
1
Description
Depression based on patient health
Timepoint
Before the intervention and six weeks after delivery
Method of measurement
The Patient Health Questionnaire-9 questionnaire
2
Description
Health promoting behaviors
Timepoint
Before and two weeks after the intervention
Method of measurement
The Health-Promoting Lifestyle Profile questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, the educational contents based on six dimensions of health-promoting behaviors are sent to the pregnant women as a PDF and audio files on a specific day and time chosen by mothers. The educational contents are sent starting from 30th week of pregnancy and continued for six weeks. one dimension of health-promoting behaviors is sent every week. These dimensions include nutrition, physical activity, stress management, health responsibility, spiritual growth, and interpersonal relations.
Category
Behavior
2
Description
Control group: The control group only receive the routine prenatal and postpartum education based on national guidelines.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Yaheinejad and Ayatollah Rouhani hospitals
Full name of responsible person
Fatemeh Bakouei
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 911 315 8440
Email
bakouei2004@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology: Dr. Mehdi Rajab Nia
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 911 315 8440
Email
bakouei2004@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3232 2589
Email
bakouei2004@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3232 2589
Email
bakouei2004@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Bakouei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Ganj Afrooz
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶۴۷۷۴۵
Phone
+98 11 3232 2589
Email
bakouei2004@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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