PRENATAL DISTRESSNCT07122115
Mindfulness-Based Childbirth Education for Pregnant Women With Distress
A study testing Mindfulness-Based Childbirth and Parenting Education in people with PRENATAL DISTRESS, run by Kayseri Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aimed to evaluate the effects of a mindfulness-based childbirth and parenting education program on pregnant women experiencing prenatal distress. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- PRENATAL DISTRESS
- What is being tested?
- Mindfulness-Based Childbirth and Parenting Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- First-time pregnancy (primigravida)
- Gestational age between 24 and 32 weeks
- No chronic medical or psychiatric conditions
- Able to participate in online sessions
- TPDS (Tilburg Pregnancy Distress Scale) score of 28 or higher
- Minimum literacy level to understand consent and questionnaires
- Voluntary participation and signed informed consent
- -
Who cannot join
- High-risk pregnancy (e.g., preeclampsia, placenta previa)
- Multiple pregnancy (e.g., twins or more)
- Existing diagnosis of major psychiatric disorders
- Participation in any previous mindfulness training
- Inability to complete follow-up assessments
- Non-consent or withdrawal from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kayseri City Training and Research Hospital
Kayseri, Kocasi̇nan, 38080
About this study
Official title: The Effect of Mindfulness-Based Childbirth and Parenting Education on Birth Parameters and Postpartum Adaptation in Pregnant Women With Distress
This randomized controlled trial aimed to evaluate the effects of a mindfulness-based childbirth and parenting education program on pregnant women experiencing prenatal distress. A total of 31 participants were randomly assigned to either an intervention group, which received an 8-week mindfulness-based education, or a control group, which received standard prenatal care. The study assessed outcomes such as pregnancy-related stress, fear of childbirth, conscious awareness, maternal attachment, and postpartum adaptation.
Read the detailed description
This study was conducted to investigate the effects of a mindfulness-based childbirth and parenting education program on pregnant women who were identified as having prenatal distress. A randomized controlled trial design was used with a pre-test/post-test model. The participants were recruited from Kayseri City Training and Research Hospital's Pregnancy School and Outpatient Clinic between November and December 2022.
A total of 201 pregnant women were screened using the Tilburg Pregnancy Distress Scale (TPDS), and 31 women who scored 28 or higher and met the inclusion criteria were selected. Participants were randomly assigned into two groups: an intervention group (n=16) that received an 8-week mindfulness-based childbirth and parenting education program, and a control group (n=15) that received standard prenatal education.
The mindfulness-based program was conducted online and included guided mindfulness practices, psychoeducation, breathing exercises, and home assignments. Each session lasted approximately 120 minutes and was held once a week for eight consecutive weeks. Participants were also encouraged to practice formal and informal mindfulness exercises at home throughout the program.
The data were collected using several validated instruments, including the Tilburg Pregnancy Distress Scale, Mindful Attention Awareness Scale (MAAS), Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ), Visual Analog Scale (VAS) for labor pain, Maternal Attachment Scale, and Postpartum Self-Evaluation Questionnaire. Data collection occurred at multiple time points: before the intervention, after the intervention, on the first postpartum day, and during the first and fourth postpartum months.
- Conditions
- PRENATAL DISTRESS
- Being tested
- Mindfulness-Based Childbirth and Parenting Education
- Keywords
- MİNDFULNESS, PRENATAL DİSTRESS, FEAR OF CHILDBİRTH, MATERNAL ATTACHMENT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Childbirth and Parenting EducationBehavioural
The intervention was an 8-week mindfulness-based childbirth and parenting education program specifically adapted for pregnant women experiencing prenatal distress. The program included weekly 120-minute online sessions combining formal mindfulness practices (such as mindful breathing, body scan, and sitting meditation), informal exercises (e.g., mindful eating, mindful walking), psychoeducation, group sharing, and guided reflections.
Participants were also asked to complete daily home practice assignments using audio recordings. The content was adapted from the Mindfulness-Based Childbirth and Parenting (MBCP) curriculum and integrated with prenatal education. The intervention was delivered by a trained instructor and tailored to meet the emotional and cognitive needs of expectant mothers.
| Study group | Role | What they receive |
|---|---|---|
| Standard Prenatal Care | No intervention | Participants in this group received routine prenatal care and standard childbirth education provided by the hospital without any mindfulness component. |
| Experimental Arm | Experimental | Participants in this group received an 8-week mindfulness-based childbirth and parenting education program, including guided mindfulness practices, psychoeducation, and home assignments. Receives: Behavioral: Mindfulness-Based Childbirth and Parenting Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Prenatal Distress Level
Measured using the Tilburg Pregnancy Distress Scale (TPDS), which assesses pregnancy-related emotional distress.
Measured: From baseline (pre-intervention) to immediately post-intervention (approximately 8 weeks)
Secondary outcomes (1)
Change in Mindful Awareness
Measured using the Mindful Attention Awareness Scale (MAAS). Higher scores indicate greater mindfulness.
Measured: Baseline and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Nov 2022
- Primary completion30 Apr 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PRENATAL DISTRESSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: an intervention group receiving mindfulness-based childbirth and parenting education, and a control group receiving standard prenatal care. Each group was followed independently throughout the study period.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kayseri Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, MERVE GÜL TİREN, Kayseri Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122115
- Sponsor's protocol ID
- KayseriTRH-distress
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical concerns regarding participant privacy, as well as institutional restrictions on data sharing without explicit participant consent.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Childbirth and Parenting Education on Birth Parameters and Postpartum Adaptation in Pregnant Women With Distress
- ClinicalTrials.gov ID
- NCT07122115
- Acronym / sponsor ID
- KayseriTRH-distress
- Conditions
- PRENATAL DISTRESS
- Keywords
- MİNDFULNESS, PRENATAL DİSTRESS, FEAR OF CHILDBİRTH, MATERNAL ATTACHMENT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Kayseri Training and Research HospitalOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aimed to evaluate the effects of a mindfulness-based childbirth and parenting education program on pregnant women experiencing prenatal distress. A total of 31 participants were randomly assigned to either an intervention group, which received an 8-week mindfulness-based education, or a control group, which received standard prenatal care. The study assessed outcomes such as pregnancy-related stress, fear of childbirth, conscious awareness, maternal attachment, and postpartum adaptation.
Detailed description
This study was conducted to investigate the effects of a mindfulness-based childbirth and parenting education program on pregnant women who were identified as having prenatal distress. A randomized controlled trial design was used with a pre-test/post-test model. The participants were recruited from Kayseri City Training and Research Hospital's Pregnancy School and Outpatient Clinic between November and December 2022.
A total of 201 pregnant women were screened using the Tilburg Pregnancy Distress Scale (TPDS), and 31 women who scored 28 or higher and met the inclusion criteria were selected. Participants were randomly assigned into two groups: an intervention group (n=16) that received an 8-week mindfulness-based childbirth and parenting education program, and a control group (n=15) that received standard prenatal education.
The mindfulness-based program was conducted online and included guided mindfulness practices, psychoeducation, breathing exercises, and home assignments. Each session lasted approximately 120 minutes and was held once a week for eight consecutive weeks. Participants were also encouraged to practice formal and informal mindfulness exercises at home throughout the program.
The data were collected using several validated instruments, including the Tilburg Pregnancy Distress Scale, Mindful Attention Awareness Scale (MAAS), Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ), Visual Analog Scale (VAS) for labor pain, Maternal Attachment Scale, and Postpartum Self-Evaluation Questionnaire. Data collection occurred at multiple time points: before the intervention, after the intervention, on the first postpartum day, and during the first and fourth postpartum months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: an intervention group receiving mindfulness-based childbirth and parenting education, and a control group receiving standard prenatal care. Each group was followed independently throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Standard Prenatal Care | No intervention | –Participants in this group received routine prenatal care and standard childbirth education provided by the hospital without any mindfulness component. |
| Experimental Arm | Experimental | Behavioral: Mindfulness-Based Childbirth and Parenting EducationParticipants in this group received an 8-week mindfulness-based childbirth and parenting education program, including guided mindfulness practices, psychoeducation, and home assignments. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- First-time pregnancy (primigravida)
- Gestational age between 24 and 32 weeks
- No chronic medical or psychiatric conditions
- Able to participate in online sessions
- TPDS (Tilburg Pregnancy Distress Scale) score of 28 or higher
Key exclusion criteria (6 listed)
- High-risk pregnancy (e.g., preeclampsia, placenta previa)
- Multiple pregnancy (e.g., twins or more)
- Existing diagnosis of major psychiatric disorders
- Participation in any previous mindfulness training
- Inability to complete follow-up assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Childbirth and Parenting EducationThe intervention was an 8-week mindfulness-based childbirth and parenting education program specifically adapted for pregnant women experiencing prenatal distress. The program included weekly 120-minute online sessions combining formal mindfulness practices (such as mindful breathing, body scan, and sitting meditation), informal exercises (e.g., mindful eating, mindful walking), psychoeducation, group sharing, and guided reflections. Participants were also asked to complete daily home practice assignments using audio recordings. The content was adapted from the Mindfulness-Based Childbirth and Parenting (MBCP) curriculum and integrated with prenatal education. The intervention was delivered by a trained instructor and tailored to meet the emotional and cognitive needs of expectant mothers. | Behavioural | Experimental Arm |
Primary outcome
Change in Prenatal Distress Level
Time frame: From baseline (pre-intervention) to immediately post-intervention (approximately 8 weeks)
Measured using the Tilburg Pregnancy Distress Scale (TPDS), which assesses pregnancy-related emotional distress.
1 secondary outcome
Change in Mindful Awareness
Time frame: Baseline and post-intervention (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical concerns regarding participant privacy, as well as institutional restrictions on data sharing without explicit participant consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Childbirth and Parenting Education in people with PRENATAL DISTRESS, run by Kayseri Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prenatal Distress Level (time frame: From baseline (pre-intervention) to immediately post-intervention (approximately 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.