Protocol summary
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Study aim
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To determine the effect of a mindfulness based on childbirth program on fear of childbirth and depression in pregnant women
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Design
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The clinical trial has intervention and control groups, randomly assigned in a parallel-group, single-blind design.
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Settings and conduct
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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 (statistical analyses). 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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group (mindfulness based on childbirth program)
and control group (routine antenatal care)
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Main outcome variables
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Fear of childbirth and Depression
General information
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Reason for update
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Registration of the final study results following completion of the clinical trial.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250801066718N1
Registration date:
2025-08-16, 1404/05/25
Registration timing:
registered_while_recruiting
Last update:
2026-10-06, 1405/07/14
Update count:
1
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Registration date
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2025-08-16, 1404/05/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-08-14, 1404/05/23
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Expected recruitment end date
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2025-12-22, 1404/10/01
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Actual recruitment start date
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2025-08-14, 1404/05/23
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Actual recruitment end date
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2025-09-23, 1404/07/01
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Trial completion date
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empty
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Scientific title
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The Effect of Mindfulness Based on Childbirth Program on Fear of Childbirth and Depression in Pregnant Women
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Public title
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Mindfulness Program on Fear of Childbirth and Depression in Pregnancy
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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).
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Age
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From 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
94
Actual sample size reached:
87
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-08-11, 1403/05/21
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Ethics committee reference number
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IR.IUMS.REC.1403.394
Health conditions studied
1
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Description of health condition studied
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Perinatal depression
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ICD-10 code
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F53.0
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ICD-10 code description
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Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
2
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Description of health condition studied
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Fear of Childbirth
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Depression score in the Edinburgh Questionnaire
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Timepoint
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Before the intervention and immediately after the intervention
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Method of measurement
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Edinburgh Postnatal Depression Scale (EPDS)
2
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Description
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Fear of Childbirth score in the Wijma Questionnaire
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Timepoint
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Before the intervention and immediately after the intervention
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Method of measurement
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Wijma delivery expectancy questionnaire (W-DEQ (A))
3
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Description
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Mindfulness score on the Five Facet Mindfulness Questionnaire
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Timepoint
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Before the intervention and immediately after the intervention
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Method of measurement
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Five Facet Mindfulness Questionnaire
Intervention groups
1
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Description
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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 7-10 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: Introduction to mindfulness, physiology of pregnancy and childbirth, and discussion of the culturally meaningful value of present-moment awareness. Raisin meditation practice.Session 2: Recognising bodily sensations, thoughts and emotions, the physiological stress response (fight-or-flight), responding to pregnancy-related fears, and practising patience when facing pregnancy-related challenges. Body scan practice.Session 3: Coping with pain and discussion of the culturally meaningful value of trust in God as a supportive coping resource. Ice exercise and mindful breathing during discomfort.Sessions 4–6: Understanding the childbirth process and labour pain, applying mindfulness to unpleasant sensations and uncertainty, and recognising and using emotional and practical support from family members. Yoga, mindful family inquiry about fear and joy, and sitting meditation.Session 7: Integrating mindfulness into childbirth and early parenting and cultivating self-compassion. Loving-kindness meditation.Session 8: Reviewing the entire course and practising previously learned mindfulness skills. Continued independent mindfulness practice, applying mindfulness to daily activities and childbirth-related experiences, and daily gratitude journaling.
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Category
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Other
2
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Description
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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.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Self-funded by the researcher
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2026-10-06, 1405/07/14
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Table of baseline comparison
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| Pregnant women |
Intervention group (n=42) |
Control group (n=45) |
p |
| Age M (SD) |
33.26 (7.74) |
30.78 (5.89) |
0.09 ͨ |
| Married ,n(%) |
42 (100) |
45 (100) |
- |
| Duration of Marriage M (SD) |
10.21 (6.56) |
7.73 (5.88) |
0.06 ͨ |
| Education level, n(%) |
|
|
0.68 ͣ |
| University education or higher |
10 (23.8) |
8 (17.8) |
|
| High school or lower |
32 (76.2) |
37 (82.2) |
|
| Employment, n(%) |
|
|
0.66 ᵇ |
| Yes |
3 (7.1) |
2 (4.4) |
|
| No |
39 (92.9) |
43 (95.6) |
|
| Income, n(%) |
|
|
0.11 ͣ |
| Less than IRR 150,000,000 |
32 (76.2) |
40 (88.9) |
|
| More than IRR 150,000,000 |
10 (23.8) |
5 (11.1) |
|
| Parity, n(%) |
|
|
0.69 ͣ |
| Nulliparous |
16 (38.1) |
19 (42.2) |
|
| Multiparous |
26 (61.9) |
26 (57.8) |
|
| Previous Mode of birth° |
|
|
0.57 ͣ |
| Vaginal |
10 (38.5) |
12 (46.2) |
|
| Cesarean |
16 (61.5) |
14 (53.8) |
|
| History of Miscarriage(s) |
|
|
0.56 ͣ |
| Yes |
9 (21.4) |
12 (26.7) |
|
| No |
33 (78.6) |
33 (73.3) |
|
| History of Infertility, n(%) |
|
|
0.51 ᵇ |
| Yes |
6 (14.3) |
4 (8.9) |
|
| No |
36 (85.7) |
41 (91.1) |
|
| Pregnancy Complications, n(%) |
|
|
0.26 ᵇ |
| Yes |
2 (4.8) |
6 (13.3) |
|
| No |
40 (95.2) |
39 (86.7) |
|
| Partners |
|
|
|
| Age, M (SD) |
37.33 (6.92) |
35.09 (5.97) |
0.10 ͨ |
| Education level, n(%) |
|
|
0.19 ͣ |
| University education or higher |
10 (23.8) |
6 (13.3) |
|
| High school or lower |
32 (76.2) |
39 (86.7) |
|
| Employment, n(%) |
|
|
0.99 ᵇ |
| Yes |
41 (97.6) |
43 (95.6) |
|
| No |
1 (2.4) |
2 (4.4) |
|
| M: Mean; SD: Standard Deviation; IRR: Iranian Rial.ᵃ Chi-Square test; ᵇ Fisher’s Exact Test; ͨ Independent t test; ° Numbers and percentages for Previous Mode of birth are based only on multiparous women (n=26 in intervention, n=26 in control). p ≤ .05 was considered significant. |
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Participant flow diagram
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| CONSORT 2025 Flow Diagram |
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| Enrolment |
|
| Assessed for eligibility |
n=215 |
| Excluded |
n=121 |
| Not meeting inclusion criteria |
n=86 |
| Declined to participate |
n=14 |
| Other reasons |
n=21 |
| Randomised |
n=94 |
| Allocation |
|
| Intervention group (n=47) |
|
| Received allocated intervention |
n=47 |
| Did not receive allocated intervention |
n=0 |
| Control group (n=47) |
|
| Received routine antenatal care |
n=47 |
| Did not receive routine antenatal care |
n=0 |
| Follow-Up: Intervention group |
|
| Discontinued intervention |
n=3: personal reasons |
| Lost to follow-up for primary outcome |
n=2: No response |
| Follow-Up: Control group |
|
| Discontinued intervention |
n=0 |
| Lost to follow-up for primary outcome |
n=2: No response |
| Analysis: Intervention group |
|
| Analysed for primary outcome |
n=42 |
| Excluded from analysis |
n=0 |
| Analysis: Control group |
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| Analysed for primary outcome |
n=45 |
| Excluded from analysis |
n=0 |
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Table of variable outcomes' results
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| Analysis of Covariance (ANCOVA) for Between-Group Differences on Post-intervention (T1) Scores, Controlling for Pre-intervention (T0) Scores |
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| Variable |
Group |
N |
Post-Test M (SD) |
Adjusted Mean (SE) |
F (1, 84) |
p |
Adjusted Mean Difference (95% CI) |
η2p |
| W-DEQ |
Intervention |
42 |
34.95 (21.16) |
34.74 (2.84) |
16.19 |
<0.001 |
-15.87 [-23.71, -8.03] |
0.162 |
|
Control |
45 |
50.40 (22.07) |
50.60 (2.74) |
|
|
|
|
| EPDS |
Intervention |
42 |
5.71 (4.54) |
6.02 (0.56) |
7.90 |
0.006 |
-2.20 [-3.76, -0.64] |
0.086 |
|
Control |
45 |
8.51 (4.42) |
8.22 (0.54) |
|
|
|
|
| FFMQ |
Intervention |
42 |
142.26 (22.19) |
141.18 (2.25) |
8.90 |
0.004 |
9.35 [3.12, 15.58] |
0.096 |
|
Control |
45 |
130.82 (20.25) |
131.83 (2.18) |
|
|
|
|
| Note: Adjusted means (Estimated Marginal Means) are reported controlling for the respective pre-intervention (T0) score as the covariate. M: Mean; SD: Standard Deviation; SE: Standard error; CI: Confidence Interval; η²: Partial eta-squared (effect size). W-DEQ: Wijma Delivery Expectancy/Experience Questionnaire; EPDS: Edinburgh Postnatal Depression Scale; FFMQ: Five Facet Mindfulness Questionnaire. Adjusted Mean Difference represents the difference between the Intervention group and the Control group (Intervention - Control). p ≤ .05 was considered significant. |
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| Descriptive Statistics and Paired t-Test Results for Within-Group Changes from Pre-intervention (T0) to Post-intervention (T1) |
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| Variable |
Group |
N |
T0 M (SD) |
T1 M (SD) |
Differences (SD)ᵃ |
t (df) |
p |
Cohen’s d |
| W-DEQ |
Intervention |
42 |
47.64 (24.17) |
34.95 (21.16) |
−12.69 (18.89) |
4.35 (41) |
<0.001 |
−0.67 |
|
Control |
45 |
46.80 (22.57) |
50.40 (22.07) |
3.60 (24.06) |
1.00 (44) |
0.321 |
0.15 |
| EPDS |
Intervention |
42 |
9.14 (5.35) |
5.71 (4.54) |
−3.43 (4.07) |
5.44 (41) |
<0.001 |
−0.84 |
|
Control |
45 |
10.24 (4.49) |
8.51 (4.42) |
−1.73 (4.40) |
2.64 (44) |
0.011 |
−0.39 |
| FFMQ |
Intervention |
42 |
134.69 (20.70) |
142.26 (22.19) |
7.57 (15.58) |
3.15 (41) |
0.003 |
0.49 |
|
Control |
45 |
132.11 (17.60) |
130.82 (20.25) |
−1.29 (14.34) |
0.60 (44) |
0.550 |
−0.09 |
| N, number of participants; SD, standard deviation; df, degrees of freedom; T0, pre-test; T1, post-test. W-DEQ, Wijma Delivery Expectancy/Experience Questionnaire; EPDS, Edinburgh Postnatal Depression Scale; FFMQ, Five Facet Mindfulness Questionnaire. ᵃMean difference = T1 post-intervention score minus T0 pre-intervention score. t values are reported as absolute values; negative values indicate a decrease in scores (desirable for W-DEQ and EPDS), whereas positive values indicate an increase in scores (desirable for FFMQ). p ≤ .05 was considered statistically significant. |
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Table of adverse events
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First publication date
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empty
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Abstract of published paper
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At post-intervention assessment, participants in the intervention group had significantly lower fear of childbirth and depression scores and significantly higher mindfulness scores than those in the control group, after adjusting for baseline scores. The between-group differences were significant for fear of childbirth (F(1,84)=16.19, p<0.001, η²p=0.162), depression (F(1,84)=7.90, p=0.006, η²p=0.086), and mindfulness (F(1,84)=8.90, p=0.004, η²p=0.096).