Clinical trial NCT06956898: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fear of Childbirth
Haptonomy
Mindfulness
Self-Efficacy
Attachment
Keywords: Attachment
Self-Efficacy
Mindfulness
Haptonomy
Fear of Childbirth
Lead sponsor: Bayburt University
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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".


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Childbirth Fear
timeFrame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
measure: Change in Childbirth Self-Efficacy
timeFrame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
measure: Change in Prenatal Attachment
timeFrame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
measure: Change in Trait Anxiety
timeFrame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"
Secondary outcomes:
Other outcomes:
measure: Personal Information Form
timeFrame: "Baseline (28th week of pregnancy)"
Locations:
Study officials:
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