Pregnancy RelatedNCT05866549
The Effect of The Mindfulness-based Childbirth and Parenting Program
A study testing Mindfulness-based Childbirth and Parenting Program in people with Pregnancy Related, run by Ezgi Findik at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of Mindfulness-based childbirth and parenting program on prenatal attachment and depression, stress and anxiety levels of pregnants. The study will be carried out in two different groups. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Mindfulness-based Childbirth and Parenting Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2023to 22 Sep 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being at 20-30 weeks of gestation
- Being nulliparous
Who cannot join
- History of psychiatric illness
- Follow-up in the risky pregnancy clinic
- Not completing the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of The Mindfulness-based Childbirth and Parenting Program on Prenatal Attachment and Depression, Stress, Anxiety Levels of Pregnants
The aim of this study is to determine the effect of Mindfulness-based childbirth and parenting program on prenatal attachment and depression, stress and anxiety levels of pregnants.
The study will be carried out in two different groups. After the pregnants are evaluated in terms of eligibility criteria for the research, the pregnants who are eligible will be informed about the research and written informed consent will be obtained from the pregnants who accept. The random distribution of pregnants to the study groups will be carried out random. The following applications will be made to the groups.
- Conditions
- Pregnancy Related
- Being tested
- Mindfulness-based Childbirth and Parenting Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Childbirth and Parenting ProgramOther
Mindfulness-based childbirth and parenting program will be applied to individuals in this group. The program consists of nine sessions, eight of which will take place during pregnancy. Sessions planned during pregnancy will be held once a week, lasting 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Other: Mindfulness-based Childbirth and Parenting Program |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prenatal Attachment Inventory
The scale, which is a four-point Likert-type scale, consists of 21 items. A minimum of 21 and a maximum of 84 points can be obtained from the scale. The change in the score obtained by the pregnant indicates that the level of attachment also increases.
Measured: immediately after participants are assigned to groups and eight weeks later
Depression Anxiety Stress Scale- 21 (DASS 21)
In this scale (DASS-21), there are 7 questions each to measure the dimensions of depression, stress and anxiety. The scale is a 4-point Likert Type Scale; 0 -3. Depression, anxiety and stress scores are measured by summing the scores of the related items. A minimum of 0 and a maximum of 21 points can be obtained in each dimension.
Measured: immediately after participants are assigned to groups and eight weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start22 May 2023
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezgi Findik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ezgi Findik, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866549
- Sponsor's protocol ID
- 20/198
- Status last verified
- Mar 2024
- First submitted
- 10 May 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Findik E, Yilmaz Sezer N, Aker MN, Badur D. The effects of the Mindfulness-Based Childbirth and Parenting Program (MBCP) on prenatal attachment, depression, stress, and anxiety in pregnant women: A randomized controlled trial. J Affect Disord. 2025 May 1;376:341-346. doi: 10.1016/j.jad.2025.02.030. Epub 2025 Feb 15.
PubMed 39961443
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of The Mindfulness-based Childbirth and Parenting Program on Prenatal Attachment and Depression, Stress, Anxiety Levels of Pregnants
- ClinicalTrials.gov ID
- NCT05866549
- Acronym / sponsor ID
- 20/198
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ezgi FindikUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 19 May 2023 (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.
The aim of this study is to determine the effect of Mindfulness-based childbirth and parenting program on prenatal attachment and depression, stress and anxiety levels of pregnants.
The study will be carried out in two different groups. After the pregnants are evaluated in terms of eligibility criteria for the research, the pregnants who are eligible will be informed about the research and written informed consent will be obtained from the pregnants who accept. The random distribution of pregnants to the study groups will be carried out random. The following applications will be made to the groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Mindfulness-based Childbirth and Parenting Program |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being at 20-30 weeks of gestation
- Being nulliparous
Key exclusion criteria (3 listed)
- History of psychiatric illness
- Follow-up in the risky pregnancy clinic
- Not completing the study
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 ProgramMindfulness-based childbirth and parenting program will be applied to individuals in this group. The program consists of nine sessions, eight of which will take place during pregnancy. Sessions planned during pregnancy will be held once a week, lasting 8 weeks. | Other | Intervention Group |
Primary outcome
Prenatal Attachment Inventory
Time frame: immediately after participants are assigned to groups and eight weeks later
The scale, which is a four-point Likert-type scale, consists of 21 items. A minimum of 21 and a maximum of 84 points can be obtained from the scale. The change in the score obtained by the pregnant indicates that the level of attachment also increases.
Depression Anxiety Stress Scale- 21 (DASS 21)
Time frame: immediately after participants are assigned to groups and eight weeks later
In this scale (DASS-21), there are 7 questions each to measure the dimensions of depression, stress and anxiety. The scale is a 4-point Likert Type Scale; 0 -3. Depression, anxiety and stress scores are measured by summing the scores of the related items. A minimum of 0 and a maximum of 21 points can be obtained in each dimension.
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 6 Mar 2024.
- Derived from this study: PubMed 39961443Findik E, Yilmaz Sezer N, Aker MN, Badur D. The effects of the Mindfulness-Based Childbirth and Parenting Program (MBCP) on prenatal attachment, depression, stress, and anxiety in pregnant women: A randomized controlled trial. J Affect Disord. 2025 May 1;376:341-346. doi: 10.1016/j.jad.2025.02.030. Epub 2025 Feb 15.
- Individual participant dataSharing planned: No
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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 Program in people with Pregnancy Related, run by Ezgi Findik 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 2 inclusion and 3 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 6 Mar 2024. 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?
Prenatal Attachment Inventory (time frame: immediately after participants are assigned to groups and eight weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866549, which also lists 1 linked publication.
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 6 Mar 2024.