Protocol summary
-
Study aim
-
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 refer to several obstetrician and gynecologist offices in District 1 of Mashhad Municipality and are selected and randomly assigned to two experimental and control groups based on the study inclusion criteria. 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 8 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
-
Main outcome variables
-
Pregnancy Anxiety؛ Mother-Fetus Attachment؛ Psychological Empowerment؛ Marital Satisfaction
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200117046165N2
Registration date:
2025-10-31, 1404/08/09
Registration timing:
registered_while_recruiting
Last update:
2026-08-25, 1405/06/03
Update count:
1
-
Registration date
-
2025-10-31, 1404/08/09
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2025-10-16, 1404/07/24
-
Expected recruitment end date
-
2025-11-15, 1404/08/24
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
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
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2025-04-16, 1404/01/27
-
Ethics committee reference number
-
IR.IAU.MSHD.REC.1404.018
Health conditions studied
1
-
Description of health condition studied
-
Pregnancy
-
ICD-10 code
-
Z34.8
-
ICD-10 code description
-
Supervision of other normal pregnancy
Primary outcomes
1
-
Description
-
Pregnancy Anxiety
-
Timepoint
-
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
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 8 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 and self-awareness during pregnancy 2) Body awareness, acceptance of the pregnancy experience, and connection with the fetus 3) Stress, anxiety, and emotion regulation management 4) Self-compassion, self-care, and reduction of rumination 5) Mindfulness in relationships, social support, and couple communication 6) Psychological preparation for childbirth and conscious exposure to pain 7) Mindfulness in parenting, newborn care, and the postpartum period 8) Conclusion, consolidation of skills, and a plan for continued practice
-
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
1
-
Sponsor
-
-
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
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