Determining the effectiveness of a education program for husbands on the promoting of social support of mothers in the postpartum period
Design
Randomized clinical trial, with control group, single blind, with parallel group
Settings and conduct
This study will be performed on husbands of pregnant mothers referring to the 17 Shahrivar Health Center in Ahvaz. First, the researcher in the face-to-face meeting will explain the objectives of the study and the type of intervention to pregnant women 39-41weeks and their husbands. Then the samples will be randomly divided into two groups of intervention and control. After completing the questionnaire online by mothers on the 3rd day after delivery, 4 online training sessions of 45 to 90 minutes (in the form of PowerPoint, lectures and questions and answers in Whats-App software) per week will be performed for the intervention group and the control group will not receive any intervention. In this study, data analyzer blinding will be performed.
Participants/Inclusion and exclusion criteria
Informed consent to participate in the study, good psychological and mental status according to the clinician's diagnosis, having at least ability to read and write
Intervention groups
Intervention group: In this group, the husbands of primiparous women receive educational content in four online sessions of 45 to 90 minutes in Whats-App software on a weekly basis.
Control group: In this group, the husbands of primiparous women receive routine care.
Main outcome variables
Social support
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160427027633N8
Registration date:2021-06-15, 1400/03/25
Registration timing:prospective
Last update:2021-06-15, 1400/03/25
Update count:0
Registration date
2021-06-15, 1400/03/25
Registrant information
Name
Foruzan Sharifipour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3828 2101
Email address
f.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-30, 1400/04/09
Expected recruitment end date
2021-08-31, 1400/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of a education program for husbands on the promoting of social support of mothers in the postpartum period
Public title
Evaluation of effectiveness of a education program on the promoting of social support of mothers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First pregnancy
Single and term pregnancy
Do not suffer from physical and mental illnesses
Do not consume alcohol and tobacco
Married and living together with his husband
Husband's desire to participate in the study
Failure to participate in similar training or counseling classes before studying
No stressful events during the past month
Having media literacy (acquaintance with how WhatsApp program)
Acquaintance with cyberspace
Having a smart phone and the possibility of accessing the WhatsApp social network
Internet access
Access to the participant within at least the next 8 weeks
Exclusion criteria:
Unwillingness of people
Infant hospitalization
Occurrence of any stressful event for couples or their first-degree family members such as death or incurable disease
Moderate to severe postpartum depression
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of subjects is block randomization with blocks with size of 4. This will be done with WinPepi11.0 software.
This software generates random groups. In each block, 2 subjects are from the control group and 2 subjects are from the intervention group, which is arranged randomly.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blindness is not possible for the researcher and participant. Therefore, in this study data analyzer blindness (lack of knowledge of the subject code) will be used, so the study will be single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-08-14, 1399/05/24
Ethics committee reference number
IR.AJUMS.REC.1399.401
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Social support
Timepoint
Before, after the end of the intervention period and 4 weeks later
Method of measurement
Postpartum Partner Support Scale
Secondary outcomes
1
Description
Efficacy of mother
Timepoint
Before, after the end of the intervention and 4 weeks later
Method of measurement
Postpartum Parental Expectations Survey
Intervention groups
1
Description
Intervention group: The educational content developed for the intervention group will be implemented after completing the questionnaire online by mothers on the 3rd day after delivery. The intervention will be as follows, first in the WhatsApp program, based on the sample size, several groups of 7 to 10 people will be formed to perform the education, then education program will be held in the form of 4 online sessions of 45 to 90 minutes in this software and in the form of PowerPoint, lectures and questions and answers in WhatsApp software and weekly (one session per week) by the researcher. If the members want, they will ask their questions and problems in the group, and if they do not want, they will solve these issues individually (private chat) with the consultant (assistant researcher). Meeting time will be held by agreement of the participants. Educational content at the first session of the importance of maternal health in the postpartum period and anatomical, physiological changes in the postpartum period (first week after delivery), second session of the effect of these changes on the mother's mental status, the importance of social support from the mother in the postpartum period and maternal care (second week after delivery), third session of the baby care and principles of breastfeeding and how to deal with its challenges (third week after delivery), fourth session of the role of the father in the postpartum period and his supportive role in helping mothers to adapt to change (fourth week after delivery). At the end of the intervention period and 4 weeks after that (in the fourth and eighth week after delivery), the questionnaire will be completed again online by mothers.
Category
Other
2
Description
Control group: For this group no intervention will perform and they will receive routine care. The questionnaire will be completed online by mothers in the 3rd day and fourth and eighth week after delivery.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Health Center
Full name of responsible person
Foruzan Sharifipour
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
sharifipour_fr91@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
abbaspoor-z762@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
70
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
Ahvaz University of Medical Sciences
Full name of responsible person
Foruzan Sharifipour
Position
Ph.D. student of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
sharifipour_fr91@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Abbaspoor
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
abbaspoor-z762@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Foruzan sharifipour
Position
Ph.D. student of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 5368
Email
sharifipour_fr91@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
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