The aim of this study was to determine the effectiveness of couple education on maternal-fetal attachment.
Design
A randomized controlled clinical trial will be performed on 110 pregnant mothers. We will use central method for Concealment of allocation sequences.
Settings and conduct
Training is done through cyberspace. The control group is divided into 5 groups of 11 people. Each group is assigned one session (45-60 minutes) per week of training and interaction.
Participants/Inclusion and exclusion criteria
Admission requirements: Age between 18 and 35 years, minimum primary education and gestational age between 18 to 28 weeks, Non-entry requirements: A history of mental illnesses, Drug abuse, Taking psychiatric medications, History of marital problems or conflicts
Intervention groups
In the intervention group, 4 training sessions are held on the role of spouse, attachment and gender preferences for couples. And the control group receives routine care.
Main outcome variables
The main outcome of this study is the degree of maternal attachment to the fetus.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210329050788N1
Registration date:2021-05-06, 1400/02/16
Registration timing:prospective
Last update:2021-05-06, 1400/02/16
Update count:0
Registration date
2021-05-06, 1400/02/16
Registrant information
Name
Elieh Abasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3311 7921
Email address
elieh_abasi@iausari.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-22, 1400/03/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of couple education on maternal-fetal attachment in pregnant women
Public title
The effect of couple education on mother-fetus attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 35 years
Minimum basic education
Gestational age between 18 to 20 weeks
Exclusion criteria:
A history of mental illnesses
Drug abuse
Taking psychiatric medications
History of marital problems or conflicts
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning mothers to intervention and control groups will be used using the allocation sequence produced based on the block method in volume 4. Because participants enter the study from different centers over time, how to hide the allocation sequence will be a central method. In this way, the allocation sequence will be escaped in the hands of someone outside the research team. Upon each person entering the study at each center, the person will be contacted and asked about assigning the person to the correct group. The person with the sequence determines the group of participants using a central list based on the individual code (the individual code is determined by the order in which they entered the study).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study has two groups of intervention and control. In addition to routine care, the intervention group receives the mentioned training and the control group receives only routine care.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shahroud University of Medical Sciences
Before the intervention and 4 weeks after the intervention
Method of measurement
Cranley Maternal Fetal Attachment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Pregnant Women- For the intervention group, 4 training classes will be held during 4 weeks.The duration of each session is 60 minutes. Session 1: Teaching about paternal role, how the spouse supports his pregnant wife and advice to do these behaviors - Session 2: Attachment to the fetus and attachment behaviors, teaching the spouse about strategies to increase attachment and advice to do these behaviors - Session 3 Parents' preferences about children's gender and its causes, factors affecting sexual preferences a) Historical, cultural and social dimensions b) Demographic and psychological dimensions (age, education, religious beliefs, beliefs, attitudes, etc.) c) Homework presentation : Advantages and disadvantages of having gender preference - Session 4: Explaining gender preferences and its psychological and social consequences to inform couples, analyzing the answers given about the advantages and disadvantages of gender preference .
Category
Prevention
2
Description
Control group: The control group receives routine care.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 12
Full name of responsible person
Fatemeh Logmani
Street address
Health Center No. 12, Shahid Nozari Alley, Tabarestan St.
City
Sari
Province
Mazandaran
Postal code
4816855487
Phone
+98 11 3324 5401
Email
floghmani93@gmail.com
2
Recruitment center
Name of recruitment center
Shahid Adibi Health Center
Full name of responsible person
Soori Mahmoodi
Street address
Shahid Adibi Health Center, between Azadegan 2 and 4, Imam Reza Boulevard
City
Sari
Province
Mazandaran
Postal code
6967048189
Phone
+98 11 3328 0547
Email
moodisoori47@gmail .com
3
Recruitment center
Name of recruitment center
Shahid Ghasemi Health Center
Full name of responsible person
Masoumeh Karimilagab
Street address
Shahid Ghasemi Health Center, Salanfarsi Ave.
City
Sari
Province
Mazandaran
Postal code
4818917367
Phone
+98 11 3310 9431
Email
elieh_abasi@yahoo.com
4
Recruitment center
Name of recruitment center
Health Center No. 7
Full name of responsible person
Atosa Kialashki
Street address
Health Center No. 7, Keshavars 6, Keshavars Blvd
City
Sari
Province
Mazandaran
Postal code
4819786343
Phone
+98 11 3323 1273
Email
shamisakia@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
7 tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 6714
Email
vcr@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Elieh Abasi
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Yas Apartment, Piroozi 34, Piroozi Avenue
City
Sari
Province
Mazandaran
Postal code
4818884554
Phone
+98 11 3311 7921
Email
elieh_abasi@iausari.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Elieh Abasi
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Yas Apartment, Piroozi 34, Piroozi Avenue
City
Sari
Province
Mazandaran
Postal code
4818884554
Phone
+98 11 3311 7921
Email
elieh_abasi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Elieh Abasi
Position
PhD Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Yas Apartment, Piroozi 34, Piroozi Avenue
City
Sari
Province
Mazandaran
Postal code
4818884554
Phone
+98 11 3311 7921
Email
elieh_abasi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
In the case of data files, information about the main outcome can be shared.
The study protocol is shareable.
The methods used in statistical analysis can be shared.
The clinical study report can be shared in the form of an article.
The code used in the analysis and data classification system can be shared.
All of the above can be shared via email if there is an individual request.
When the data will become available and for how long
Six months after the results were published
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Just to help with future research. Data and documentation are provided only to inspire working methods, especially in review studies, and the type of use should be reported by the applicant after use.
From where data/document is obtainable
elieh abasi email address: elieh_abasi@yahoo.com
What processes are involved for a request to access data/document
The requested file and the reason for the request and the type of use should be sent via email.Files that are received six months after the publication of the article and the reason and type of use is justified, the requested information will be sent to them within a maximum of one week.