To determine the effect of a mindfulness based on childbirth program on fear of childbirth and depression in pregnant women
Design
The clinical trial has intervention and control groups, randomly assigned in a parallel-group, single-blind design.
Settings and conduct
This study will be conducted at Shahid Akbarabadi Hospital with two groups (intervention and control), using a four-block randomization method in a single-blind design (participants blinded). The study will compare the effect of a mindfulness-based childbirth preparation program on fear of childbirth and depression in pregnant women before and immediately after the intervention in both groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Pregnant women over 18 years old, with a singleton pregnancy (15–22 weeks), perceived stress score ≥ 28, normal BMI, Iranian ethnicity, able to attend all sessions, literate in Persian, and with adequate hearing, speaking, and comprehension abilities.
Exclusion Criteria:
Before the study: Alcohol or drug abuse, prior mindfulness experience, major medical or psychiatric disorders, history of fetal anomalies, or use of certain medications (anticonvulsants, antidepressants, thyroid hormones, corticosteroids).
During the study: Missing >2 sessions, withdrawal, fetal anomalies, obstetric complications, major adverse life events, or development of psychiatric disorders.
Intervention groups
Intervention group (mindfulness based on childbirth program)
and control group (routine prenatal care and education)
Main outcome variables
Fear of childbirth and Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250801066718N1
Registration date:2025-08-16, 1404/05/25
Registration timing:registered_while_recruiting
Last update:2025-08-16, 1404/05/25
Update count:1
Registration date
2025-08-16, 1404/05/25
Registrant information
Name
Badriyeh Daniyali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 429 7246
Email address
badrieh.dn@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-14, 1404/05/23
Expected recruitment end date
2025-12-22, 1404/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Mindfulness Based on Childbirth Program on Fear of Childbirth and Depression in Pregnant Women
Public title
Mindfulness Program on Fear of Childbirth and Depression in Pregnancy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Perceived Stress Score equal to or greater than 28
Singleton pregnancy
Gestational age between 15 and 22 weeks
Maternal age above 18 years
Ability to attend all educational sessions
Ability to read and write in Persian
Iranian ethnicity of the mother
Normal maternal body mass index (BMI)
Full consciousness and adequate hearing and speaking ability to receive training and respond to questions
Exclusion criteria:
Alcohol and drug addiction
Any history of mindfulness training or meditation
History of previous fetal anomaly
History of maternal treatment with anticonvulsants, antidepressants, thyroid hormones, and cortisone
History or current presence of medical disorders
History of serious psychiatric disorders, including psychotic disorders, bipolar disorder, depression, and medication use confirmed by a physician (based on the medical history obtained by the researcher from the pregnant mother and the information documented in her medical record).
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants will be continuously enrolled in the study. They will then be randomly assigned in blocks of four to either the intervention group (mindfulness based on childbirth program) or the control group (routine prenatal education and care). The randomization sequence will be generated using the SealedEnvelope website.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyst will be blinded to the group allocation (intervention or control) and will receive only coded data for statistical analyses.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Deputy of Research and Technology, Central Headquarters Building, Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-08-11, 1403/05/21
Ethics committee reference number
IR.IUMS.REC.1403.394
Health conditions studied
1
Description of health condition studied
Perinatal depression
ICD-10 code
F53.0
ICD-10 code description
Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
2
Description of health condition studied
Fear of Childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Depression score in the Edinburgh Questionnaire
Timepoint
Before the intervention and immediately after the intervention
Method of measurement
Edinburgh Postnatal Depression Scale (EPDS)
2
Description
Fear of Childbirth score in the Wijma Questionnaire
Timepoint
Before the intervention and immediately after the intervention
This study was designed as an educational–psychological intervention with an intervention group (mindfulness based on childbirth program) and a control group (routine prenatal care and education) in 2025 . At the first visit, all mothers (both control and intervention groups) in the 15th–22nd weeks of pregnancy, or during gatherings in the waiting room, were provided with the necessary information about the study, the existing groups, and its objectives.Mothers in the intervention group, who were randomly selected during the visit, could voluntarily choose their preferred session times according to the schedule if they were willing to participate. After signing the informed consent form and receiving the necessary explanations, the Perceived Stress Questionnaire was completed by the intervention group. If the score obtained from the questionnaire was above 28 and the inclusion criteria were met, the mother was enrolled in the intervention.The measurement tools included the Wijma Delivery Expectancy/Experience Questionnaire, the Edinburgh Postnatal Depression Scale, and the Five Facet Mindfulness Questionnaire. The scores obtained from these questionnaires were assessed and recorded before the intervention.In the intervention group, women were divided into subgroups of 10–15 participants, each consisting of both multiparous and primiparous women. Eligible mothers in the intervention group attended in-person mindfulness sessions once a week for a total of eight sessions, and the data were documented in the relevant checklist. The intervention was delivered in person, once a week, for three hours per session, over eight consecutive weeks.Session 1: Awareness of the unknown world of changes during pregnancy and childbirth. Session 2: Sharing present-moment experiences, feelings, and thoughts. Session 3: Mind–body connection in coping with labor pain. Session 4: Mechanisms of trust and compassion in dealing with fear-related rumination. Session 5:Inner preparation for childbirth and resilience. Session 6:Direct experience of mind–body connection in coping with pain. Session 7:Compassion, kindness, and trust in coping with pain. Session 8: Developing inner resources and a sense of security in facing labor pain.
Category
Other
2
Description
Control group: At the first visit, all mothers (both control and intervention groups) in the 15th–22nd weeks of pregnancy, or during gatherings in the waiting room, were provided with the necessary information about the study, the existing groups, and its objectives. The control group received only routine prenatal care and education. Mothers in the control group who were randomly selected during the visit, after completing the informed consent form and receiving the necessary explanations, completed the Perceived Stress Questionnaire. If the score obtained from the Perceived Stress Questionnaire was above 28 and the inclusion criteria were met, the mother was enrolled in the study.The measurement tools included the Wijma Delivery Expectancy/Experience Questionnaire, the Edinburgh Postnatal Depression Scale, and the Five Facet Mindfulness Questionnaire, which were completed by the control group mothers before the start of the intervention and again eight weeks later. The obtained scores from these questionnaires were then analyzed.Pregnant women in the control group will be offered the opportunity to receive the mindfulness based on childbirth program after the completion of the study, if they wish.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbarabadi Hospital
Full name of responsible person
Dr.Nahid Akbari
Street address
Bagh Ferdows Station, , Molavi St. ,Tehran
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Majid Safa – Vice President for Research and Technology
Street address
Iran University of Medical Sciences (IUMS), Shahid Hemmat highway, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
intl@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Nahid Akbari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing & Midwifery Rashid Yasemi St. Valiasr St. Tehran- Iran
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Phone
0098 21 8882886
Email
akbari1420@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Badriyeh Daniyali
Position
Master’s student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 4, Hadis 1 Building, Alley 3, Ayatollah Sadr St., Molavi Blvd., Tehran, Iran
City
Shiraz
Province
Fars
Postal code
7145898671
Phone
+98 917 429 7246
Email
badrieh.dn@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Badriyeh Daniyali
Position
Master’s student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Unit 4, Hadis 1 Building, Alley 3, Ayatollah Sadr St., Molavi Blvd., Tehran, Iran
City
Shiraz
Province
Fars
Postal code
7145898671
Phone
+98 917 429 7246
Email
badrieh.dn@gmail.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
Undecided - It is not yet known if there will be 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