Protocol summary

Study aim
The aim of this study was to increase the maternal-fetal attachment, which plays an important role in the health of pregnant and fetal mother..
Design
In the intervention group, educational classes with topics related to maternal and fetal attachment and mother's happiness in six sessions and 90 minutes each session are done weekly. In this research, the samples were randomly assigned to two groups, which included the experimental group and the control group. 84 subjects were included in the control group, 42 in the control group and 42 in the experimental group.
Settings and conduct
Pregnant women with unplanned pregnancy referring to perinatal clinics of Hazrat Zaynab and Shooshtari hospitals and the community of the research community constitute the research.
Participants/Inclusion and exclusion criteria
1- Women Without Pregnancy 2. Failure to have mental disorders (psychosis, schizophrenia) 3. Ability to attend classes and complete the written consent form. 4. Earn a mental health score of less than 22 5. Lack of participation in any kind of educational class including physiological delivery Exit criteria: 1-Unwillingness to continue cooperation 2. The occurrence of any pregnancy problem during the study (preterm labor, decolletage, etc.) 3-Uncomfortable company in training classes (2 sessions and more)
Intervention groups
The experimental group, which includes pregnant mothers with a gestational age of at least 28 weeks pregnant, is divided into three groups of 15 and will be formed for each classroom group. The researcher, while introducing himself and expressing the objectives of the plan, will participate in the participation of the subjects There will be no intervention for the control group and mothers will routinely visit hospitals for routine pregnancy care.
Main outcome variables
maternal and fetal attachment; mother's happiness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130710013940N5
Registration date: 2019-02-02, 1397/11/13
Registration timing: prospective

Last update: 2019-02-02, 1397/11/13
Update count: 0
Registration date
2019-02-02, 1397/11/13
Registrant information
Name
Marzieh Akbarzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
akbarzadm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-14, 1397/11/25
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of attachment training on maternal and fetal attachment and happiness of Unintended pregnant women referring to selected hospitals of Shiraz University of Medical Sciences 1396
Public title
The effect of attachment training on the attachment of mother and son, and Shadkami
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Women Without Pregnancy 2. Failure to have mental disorders (psychosis, schizophrenia) 3. Ability to attend classes and complete the written consent form. 4. Earn a mental health score of less than 22 5. Lack of participation in any kind of educational class including physiological delivery
Exclusion criteria:
participation in any kind of educational class including physiological delivery
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 84
Randomization (investigator's opinion)
Randomized
Randomization description
By simple sampling, the subjects referred to the two medical centers that are eligible, are randomly divided into intervention and control groups. In this study, the allocation of people to the two groups was done using the permutation block method Became In this method A represents the person receiving the intervention and B represents the individual in the group The control is. Considering the quadruple block; the AABB code 0 reversal, to ABAB's permutation Code 1, to ABBA Code 2, to BAAB Code 3, to BBAA Code 4 and to BABA Code 5 to 9. Then use the random number table to select the starting point randomly, followed by 21 Consider the number as a row or column. Given the order of the table numbers, to any number We hit the corresponding permutation for it, for example, if the first three numbers of the random number table 1, 0 and 5, respectively. The order of receiving treatment by the first 12 people in two groups, respectively, was from left to Right ABABAABBBABA will be. So finally choose 21 of the table of the way Allocation of a total of 84 people will be identified in two groups
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 Shiraz university of medical sciences
Street address
36 Zand streat
City
Shiraz
Province
Fars
Postal code
7444135554
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.SUMS.REC.1397.100

Health conditions studied

1

Description of health condition studied
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
1.The percentage of attachment – fetal attachment in wanted pregnancy
Timepoint
Before the intervention ، 2 weeks after the end of the training session
Method of measurement
Maternal Attachment Questionnaire

2

Description
2.The percentage of attachment – fetal attachment in unwanted pregnancy
Timepoint
Before the intervention ، 2 weeks after the end of the training session
Method of measurement
Maternal Attachment Questionnaire

3

Description
The percent of women's happiness in wanted pregnancy
Timepoint
Before the intervention ، 2 weeks after the end of the training session
Method of measurement
Oxford Happiness Inventory,

4

Description
The percent of women's happiness in unwanted pregnancy
Timepoint
Before the intervention ، 2 weeks after the end of the training session
Method of measurement
Oxford Happiness Inventory,

Secondary outcomes

empty

Intervention groups

1

Description
1. Intervention group Include pregnant mothers with a gestational age of at least 28 weeks in gestational age of at least 28 weeks divided into three groups of 15 and will be formed for each classroom group. The training sessions included in the intervention group include the importance of maternal and fetal attachment, maternal attachment outcomes And embryos during infancy, teaching how to develop mother and fetus attachment skills, teaching the effect of happiness on pregnancy, methods of creating happiness and its benefits for mother and baby, educating breastfeeding exclusively. Training sessions are 4 weeks and one week in a session. Before and after the intervention, maternal attachment questionnaire and happiness and general health were The researcher will be completed.
Category
N/A

2

Description
2.Control group Includes mothers who are not interrogated by the researcher and are used by the routine care of the hospital.At the same time as the intervention group, the beginning of the study phase and after 4 weeks of training, the intervention group at the end of week 38 will be considered for the attachment of mother to fetus and happiness and general health of the control group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Masomeh Kaviani
Street address
Shiraz, Chamran St., Beginning of Abyverdi
City
Shiraz
Province
Fars
Postal code
۳۴۷۸۶-۷۱۹۴۶
Phone
+98 71 3647 9494
Fax
+98 71 3647 4250
Email
Hafez@sums.ac.ir
Web page address
https://www.sums.ac.ir/

2

Recruitment center
Name of recruitment center
Shooshtari Hospital
Full name of responsible person
Masomeh Kaviani
Street address
Shiraz-Enghelab (Nader)
City
Shiraz
Province
Fars
Postal code
7173775617
Phone
+98 71 3232 4805
Email
shoushtari@sums.ac.ir

3

Recruitment center
Name of recruitment center
Za'inab Hospital
Full name of responsible person
Masomeh Kaviani
Street address
Shiraz intersection of Sacred Defense
City
shiraz
Province
Fars
Postal code
۷۱۵۳۸۱۳۳۱۱
Phone
+98 71 3726 6811
Email
zeinabhp@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Yonese Ghasemy
Street address
Class 7 - Research shiraz fars Iran, Islamic Republic Of ،Sakhtmtn Central University -، Next to the Red Crescent - ،Shiraz - Zand Street -
City
Shiraz
Province
Fars
Postal code
7444135554
Phone
+98 71 5272 1655
Fax
Email
Akbarzadm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fahime Hasanzade
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
36 Zand streat
City
Shiraz
Province
Fars
Postal code
7444135554
Phone
+98 71 5272 1655
Email
Akbarzadm@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
marzieh akbarzadeh
Position
Assistant professor of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
36 Ztand strea
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 716474254
Fax
Email
Akbarzadm@sums.ac.ir
Web page address
https://www.sums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fahime Hasanzade
Position
Midwife
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
36 zand streat
City
Shiraz
Province
Fars
Postal code
7518759338
Phone
+98 71 5272 1655
Email
Akbarzadm@sums.ac.ir
Web page address

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
The whole data information after being unidentifiable is shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
To carry out more clinical trials and further advancement in this field
From where data/document is obtainable
To the email address below fahime.fati91@gmail.com or to the Vice-Chancellor for Research in Shiraz University of Medical Sciences.
What processes are involved for a request to access data/document
Applying for yourself and your research work, the purpose of using the data is to indicate your contact number and address.
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