Fear of ChildbirthNCT06956898
The Effect of Mindfulness-Based Intervention and Haptonomy Application on Birth Self-Efficacy, Prenatal Attachment and Anxiety Levels of Pregnant Women With Fear of ChildBirth
A study testing Mindfulness Training and Haptonomy Training in people with Fear of Childbirth and Haptonomy, run by Bayburt University.
Trial summary
Fear of childbirth is a common condition encountered during pregnancy. Women with fear of childbirth have reduced birth self-efficacy, and it leads to mental health problems in the prenatal and postnatal periods, reducing mother-infant bonding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fear of Childbirth, Haptonomy, Mindfulness
- What is being tested?
- Mindfulness Training and Haptonomy Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Being a primary school graduate,
- Women in their 28th week of pregnancy,
- Being primigravida,
- Women with a healthy pregnancy,
- Women with a Wijma Childbirth Expectation/Experience Scale version A score of ≥38,
- Women who agree to participate in the study and do not have any chronic health problems that would prevent them from participating.
Who cannot join
- Pregnant women who did not agree to participate in the study or who left the study at any stage of the study will constitute the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Fear of childbirth is a common condition encountered during pregnancy. Women with fear of childbirth have reduced birth self-efficacy, and it leads to mental health problems in the prenatal and postnatal periods, reducing mother-infant bonding. Therefore, it is of critical importance to implement effective and applicable interventions focused on health and well-being to reduce fear of childbirth. Considering the increasing cesarean section rates today, holistic intervention strategies that can positively affect the birth experiences of pregnant women and support their psychological well-being are needed. In this sense, mindfulness and haptonomy applications, which are holistic intervention strategies, will allow us to meet the psychological and emotional needs of pregnant women with fear of childbirth and improve their birth experiences.
No study has been found in the literature that systematically evaluates the effects of a holistic intervention strategy for women with fear of childbirth during pregnancy. This study will enable the development of new and effective intervention strategies that can be used in prenatal and postnatal care practices and will guide clinical practices to make pregnant women's birth experiences more positive. In this study, the effects of mindfulness-based intervention and haptonomy application on childbirth self-efficacy, prenatal attachment and anxiety levels in pregnant women experiencing fear of childbirth will be evaluated. This research will be conducted as a randomized controlled experimental study. The data of the research will consist of 225 women (75 in the mindfulness group, 75 in the haptonomy group, and 75 in the control group) who applied to the Erzurum City Hospital Gynecology and Obstetrics Clinic between 01.06.2024 and 01.07.2025. The data will be collected face to face using the "Personal Information Form", "Wijma Childbirth Expectation/Experience Scale Version A", "Prenatal Attachment Inventory", and "State Anxiety Scale".
- Conditions
- Fear of Childbirth, Haptonomy, Mindfulness, Self-Efficacy, Attachment
- Being tested
- Mindfulness Training, Haptonomy Training
- Keywords
- Attachment, Self-Efficacy, Mindfulness, Haptonomy, Fear of Childbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingOther
Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.
Haptonomy TrainingOther
Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Group | Experimental | Providing mindfulness training Receives: Other: Mindfulness Training |
| Haptonomy Group | Experimental | Providing haptonomy training Receives: Other: Haptonomy Training |
| Control Group | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Childbirth Fear
Change in Fear of Childbirth Measure: Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A) Description: The W-DEQ-A is a 33-item Likert-type scale developed to assess fear of childbirth, labor-related thoughts and emotions, and anticipated stress. Each item is scored from 0 ("completely") to 5 ("not at all"), with some items reverse-coded. Total scores range from 0 to 165. Higher scores indicate greater fear of childbirth.
Unit of Measure: Score on W-DEQ-A (0-165) Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Measured: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Change in Childbirth Self-Efficacy
Measure: Childbirth Self-Efficacy Inventory (CSEI)
Description: The CSEI measures women's confidence in coping with labor. It consists of 32 items divided into two subscales: outcome expectancy and efficacy expectancy. Each item is rated on a scale from 1 to 10. Total scores range from 32 to 320. Higher scores reflect greater self-efficacy during childbirth.
Unit of Measure: Score on CSEI (32-320)
Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Measured: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Change in Prenatal Attachment
Measure: Prenatal Attachment Inventory (PAI)
Description: The PAI is a 21-item instrument used to assess a pregnant woman's emotional attachment to her unborn baby. Items are scored from 1 to 4. Total scores range from 21 to 84. Higher scores indicate stronger prenatal attachment.
Unit of Measure: Score on PAI (21-84)
Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Measured: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Change in Trait Anxiety
Measure: State-Trait Anxiety Inventory - Trait Form (STAI-T)
Description: The STAI-T measures an individual's general tendency to experience anxiety. The scale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80. Higher scores indicate higher levels of trait anxiety.
Unit of Measure: Score on STAI-T (20-80)
Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Measured: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study startMay 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear of ChildbirthStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayburt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafsa Kübra, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956898
- Sponsor's protocol ID
- 14219
- Status last verified
- Apr 2025
- First submitted
- 14 Jan 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research is still in the implementation phase.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Intervention and Haptonomy Application on Birth Self-Efficacy, Prenatal Attachment and Anxiety Levels of Pregnant Women With Fear of ChildBirth
- ClinicalTrials.gov ID
- NCT06956898
- Acronym / sponsor ID
- 14219
- Conditions
- Fear of Childbirth, Haptonomy, Mindfulness, Self-Efficacy, Attachment
- Keywords
- Attachment, Self-Efficacy, Mindfulness, Haptonomy, Fear of Childbirth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Bayburt UniversityUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 May 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.
Fear of childbirth is a common condition encountered during pregnancy. Women with fear of childbirth have reduced birth self-efficacy, and it leads to mental health problems in the prenatal and postnatal periods, reducing mother-infant bonding. Therefore, it is of critical importance to implement effective and applicable interventions focused on health and well-being to reduce fear of childbirth. Considering the increasing cesarean section rates today, holistic intervention strategies that can positively affect the birth experiences of pregnant women and support their psychological well-being are needed. In this sense, mindfulness and haptonomy applications, which are holistic intervention strategies, will allow us to meet the psychological and emotional needs of pregnant women with fear of childbirth and improve their birth experiences.
No study has been found in the literature that systematically evaluates the effects of a holistic intervention strategy for women with fear of childbirth during pregnancy. This study will enable the development of new and effective intervention strategies that can be used in prenatal and postnatal care practices and will guide clinical practices to make pregnant women's birth experiences more positive. In this study, the effects of mindfulness-based intervention and haptonomy application on childbirth self-efficacy, prenatal attachment and anxiety levels in pregnant women experiencing fear of childbirth will be evaluated. This research will be conducted as a randomized controlled experimental study. The data of the research will consist of 225 women (75 in the mindfulness group, 75 in the haptonomy group, and 75 in the control group) who applied to the Erzurum City Hospital Gynecology and Obstetrics Clinic between 01.06.2024 and 01.07.2025. The data will be collected face to face using the "Personal Information Form", "Wijma Childbirth Expectation/Experience Scale Version A", "Prenatal Attachment Inventory", and "State Anxiety Scale".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Group | Experimental | Other: Mindfulness TrainingProviding mindfulness training |
| Haptonomy Group | Experimental | Other: Haptonomy TrainingProviding haptonomy training |
| Control Group | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being a primary school graduate,
- Women in their 28th week of pregnancy,
- Being primigravida,
- Women with a healthy pregnancy,
- Women with a Wijma Childbirth Expectation/Experience Scale version A score of ≥38,
Key exclusion criteria (1 listed)
- Pregnant women who did not agree to participate in the study or who left the study at any stage of the study will constitute 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 TrainingPrimiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week. | Other | Mindfulness Group |
| Haptonomy TrainingPrimiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week. | Other | Haptonomy Group |
Primary outcome
Change in Childbirth Fear
Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Change in Fear of Childbirth Measure: Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ-A) Description: The W-DEQ-A is a 33-item Likert-type scale developed to assess fear of childbirth, labor-related thoughts and emotions, and anticipated stress. Each item is scored from 0 ("completely") to 5 ("not at all"), with some items reverse-coded. Total scores range from 0 to 165. Higher scores indicate greater fear of childbirth. Unit of Measure: Score on W-DEQ-A (0-165) Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Change in Childbirth Self-Efficacy
Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Measure: Childbirth Self-Efficacy Inventory (CSEI) Description: The CSEI measures women's confidence in coping with labor. It consists of 32 items divided into two subscales: outcome expectancy and efficacy expectancy. Each item is rated on a scale from 1 to 10. Total scores range from 32 to 320. Higher scores reflect greater self-efficacy during childbirth. Unit of Measure: Score on CSEI (32-320) Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Change in Prenatal Attachment
Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Measure: Prenatal Attachment Inventory (PAI) Description: The PAI is a 21-item instrument used to assess a pregnant woman's emotional attachment to her unborn baby. Items are scored from 1 to 4. Total scores range from 21 to 84. Higher scores indicate stronger prenatal attachment. Unit of Measure: Score on PAI (21-84) Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Change in Trait Anxiety
Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Measure: State-Trait Anxiety Inventory - Trait Form (STAI-T) Description: The STAI-T measures an individual's general tendency to experience anxiety. The scale consists of 20 items rated on a 4-point Likert scale. Total scores range from 20 to 80. Higher scores indicate higher levels of trait anxiety. Unit of Measure: Score on STAI-T (20-80) Time Frame: Baseline (Week 28), immediately after training (Week 37), and two weeks after training (Week 39)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Individual participant dataSharing planned: No. The research is still in the implementation phase.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Training and Haptonomy Training in people with Fear of Childbirth and Haptonomy, run by Bayburt University.
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 6 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hafsa Kübra Işık, Research Assistant, MSc (+90 546 540 44 22, hafsakubra@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Childbirth Fear (time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"). The study lists 4 primary outcomes in all. 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 4 May 2025; AzTrials last refreshed its copy on 27 Oct 2026.