Effectiveness of educational package of psychological care during pregnancy based on mindfulness on pregnancy anxiety, mother-fetus attachment, psychological empowerment and marital satisfaction of pregnant womens
To investigate the effectiveness of a mindfulness-based educational package for psychological care during pregnancy on pregnancy anxiety, mother-fetus attachment, psychological empowerment, and marital satisfaction
Design
Clinical trial with control group, with parallel groups, randomized and without blinding on 40 pregnant women
Settings and conduct
Primiparous pregnant women who visit several obstetrician and gynecologist offices in District 1 of Mashhad Municipality will be selected purposively according to the study inclusion criteria and randomly assigned to two experimental and control groups. Pre-test, training, post-test, and follow-up will be conducted 45 days after the intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged Between 20 to 35 years, The first pregnancy, between 2nd to 6th month of pregnancy, informed consent, no addiction, no psychiatric disorders, no medical and obstetric problems, no mental crisis
Exclusion criteria: The presence of obvious fetal abnormalities, Unwillingness or inability to participate in sessions
Intervention groups
Intervention group: The mindfulness-based prenatal psychological care educational package developed by the researcher will be held for primiparous pregnant women during 9 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions on mental health and psychological care during pregnancy is based on mindful pregnancy for better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment.
Control group: In order to observe ethics in research, after the end of intervention, two educational sessions will be received
Effectiveness of educational package of psychological care during pregnancy based on mindfulness on pregnancy anxiety, mother-fetus attachment, psychological empowerment and marital satisfaction of pregnant womens
Public title
Investigating the effect of educational package of psychological care during pregnancy based on mindfulness on pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 20 to 35 years
The first pregnancy
Being between the 2nd to 6th month of pregnancy
Having at least a high school diploma
Residing in Mashhad city
Desired pregnancy
Informed consent to participate in the research
No addiction and not being treated for psychiatric disorders
No medical and obstetric problems based on medical records (diabetes, blood pressure, previous miscarriage, etc.)
No mental crisis such as separation and death of loved ones during the 6 months prior to the research
No attendance at yoga and meditation classes
Exclusion criteria:
The presence of obvious fetal abnormalities
Unwillingness or inability to participate in sessions
Having other medical and psychiatric disorders
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be based on a simple random method. Therefore, a random number is assigned to each patient by the table of random numbers, according to which if the number is odd, the patient will be in the intervention group, and if it is an even number, the patient will be in the control group
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 the Faculty of Medicine, Islamic Azad University
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
The Vandenberg Pregnancy Related Anxiety Questionnaire
2
Description
Mother-Fetus Attachment
Timepoint
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
The Cranly Mother-Fetus Attachment Questionnaire
3
Description
Psychological Empowerment
Timepoint
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
Kameda’s Prenatal Psychological Empowerment Scale
4
Description
Marital Satisfaction
Timepoint
Before the intervention, after the intervention, 45 days after the end of the intervention
Method of measurement
Enrich Marital Satisfaction Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Primiparous pregnant women will undergo the mindfulness-based prenatal psychological care educational package intervention developed by the researcher during 9 sessions of 90 minutes (two sessions per week) for 1 month. The content of the sessions is related to obtaining information about mental health and psychological care with a mindful pregnancy and performing mindfulness exercises to gain peace and better management of this period. Mindfulness helps people live with less stress and anxiety by focusing on being in the present moment and becoming aware of thoughts, feelings, and experiences without judgment. The summary of the content of each session is as follows: 1) Introduction to mindfulness 2) Mindful connection with the body and acceptance of physical and mental changes 3) Mindful management of stress and anxiety 4) Management of thoughts and emotions 5) Mindful communication with the fetus 6) Mindful supportive and marital relationships 7) Mindful management of pain and physical discomfort 8) Preparation for a mindful birth 9) Planning for the postpartum period
Category
Treatment - Other
2
Description
Control group: This group will not receive any intervention. In order to observe ethics in research, after the end of intervention, two educational sessions will be provided for this group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Healthcare centers
Full name of responsible person
narges zarei
Street address
between Qazi Tabatabaei 14 and 16, Shahid Qazi Tabatabaei Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 915 400 7017
Email
nargeszarei57@yahoo.com
2
Recruitment center
Name of recruitment center
Mothers' Paradise Midwifery Consulting Center
Full name of responsible person
Maryam Bazshad
Street address
Third floor- Iranian Building- Kohsangi 8
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 915 559 5377
Email
nargeszarei57@yahoo.com
3
Recruitment center
Name of recruitment center
Gynecologist's office of Dr. Zahra Mohsenian
Full name of responsible person
Zahra Mohsenian
Street address
Fourth Floor- Sina Doctors Building- Aref Street 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 915 312 6470
Email
nargeszarei57@yahoo.com
4
Recruitment center
Name of recruitment center
Gynecologist's office of Dr. Parisa Najafi
Full name of responsible person
Parisa Najafi
Street address
Nikan Building- Aref Street 2
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 51 3846 0217
Email
nargeszarei57@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
narges zarei
Street address
Mohammadiyeh 23, Islamic Azad University
City
Mashhad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 915 400 7017
Email
mashhad@iau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Mashhad Branch
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
Islamic Azad University
Full name of responsible person
Narges Zarei
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Between Qazi Tabatabaei 14 and 16, Shahid Qazi Tabatabaei Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 51 3726 3725
Email
nargeszarei57@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Rajaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University, Mohammadiyeh 23, Mohammadiyeh Blvd., Qasem abad
City
Mashsad
Province
Razavi Khorasan
Postal code
9187147578
Phone
+98 915 580 3467
Email
rajaei.46@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Narges Zarei
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Between Qazi Tabatabaei 14 and 16, Shahid Qazi Tabatabaei Boulevard
City
Mashsad
Province
Razavi Khorasan
Postal code
9184983765
Phone
+98 51 3726 3725
Email
nargeszarei57@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
No - There is not 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