Protocol summary

Study aim
Comparing the effect of mindfulness-based childbirth and parenting education and routine care on maternal-fetal attachment
Design
In this research, 40 eligible pregnant women refer to will be chosen. Women will be allocated to two equal groups of intervention and control according to block randomization method.
Settings and conduct
This interventional study with quasi-experimental design and one control and one intervention group will be conducted on Ahvaz East and West Health Cares and Ahvaz Emam Khomeini clinic.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having 18-35 years old; being on 16-28 weeks of gestation; singleton pregnancy; having the ability to read and write. Exclusion criteria: Having clinical and obstetric problems; having acute psychiatric disorders; having cigarettes or alcohol addictions or drugs abuse; having history of abnormal stressful conditions due to unpleasant life events such as death of husband or other family members, divorce, huffing with husband, and being of husband on prison.
Intervention groups
Intervention group will receive mindfulness-based childbirth and parenting education weekly during 9 weeks by researcher, while control group will receive only routine care.
Main outcome variables
Maternal-fetal attachment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180108038272N1
Registration date: 2018-02-21, 1396/12/02
Registration timing: registered_while_recruiting

Last update: 2018-02-21, 1396/12/02
Update count: 0
Registration date
2018-02-21, 1396/12/02
Registrant information
Name
zeinab gheibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4363 2403
Email address
z.gheibi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of mindfulness-based childbirth and parenting education and routine care on maternal-fetal attachment
Public title
Effect of mindfulness-based childbirth and parenting education on maternal-fetal attachment
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having 18-35 years old Being on 16-28 weeks of gestation Singleton Pregnancy Having the ability to read and write
Exclusion criteria:
Having clinical and obstetric problems Having acute psychiatric disorders Having cigarettes or alcohol addictions or drugs abuse Having history of abnormal stressful conditions due to unpleasant life events such as death of husband or other family members, divorce, huffing with husband, and being of husband on prison
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: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Pregnant women will be allocated to two equal groups of intervention and control according to block randomization method.
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 Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.AJUMS.RE.1396.711

Health conditions studied

1

Description of health condition studied
Maternal-fetal attachment
ICD-10 code
O26
ICD-10 code description
Maternal care for other conditions predominantly related to pregnancy

Primary outcomes

1

Description
Maternal-fetal attachment
Timepoint
Before and immediately at the end of intervention
Method of measurement
The Maternal-Foetal Attachment Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group will receive mindfulness-based childbirth and parenting education weekly during 9 weeks by researcher.
Category
Behavior

2

Description
Control group: control group will receive only routine care.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz West Health Care
Full name of responsible person
Zeinab Ghaebi
Street address
In front of Haft Tir park, Shahid Rastegari Street, Aeatollah Behbahani Blvard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3221 5633
Email
zeinab_gheibi@yahoo.com

2

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeyni clinic
Full name of responsible person
Zeinab Ghaebi
Street address
Imam Khomeyni clinic, Azadegan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
zeinab_gheibi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Behzad Sharif Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
zeinab_gheibi@yahoo.com
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
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
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadi Far
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 61 3373 8331
Email
Nahidjavadifar_341@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Nahid Javadi Far
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715749
Phone
+98 61 3373 8331
Email
nahidjavadifar_341@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zeinab Gaeibi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
zeinab_gheibi@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of patients demographical data and main outcomes will be shared.
When the data will become available and for how long
Six months after data publishing
To whom data/document is available
Data will be available only for researchers working on academic and university associations.
Under which criteria data/document could be used
Mention of study name and authors name
From where data/document is obtainable
Zeinab Ghaibi: School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
What processes are involved for a request to access data/document
At last one month after request
Comments
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