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

NCT ID: NCT06956898

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-12-31

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".

Conditions

Fear of Childbirth; Haptonomy; Mindfulness; Self-Efficacy; Attachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Mindfulness Group

Providing mindfulness training

Group Type: EXPERIMENTAL

Mindfulness Training

Intervention Type: OTHER

Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.

Haptonomy Group

Providing haptonomy training

Group Type: EXPERIMENTAL

Haptonomy Training

Intervention Type: OTHER

Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.

Control Group

No intervention will be applied to the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Training

Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.

Intervention Type: OTHER

Haptonomy Training

Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayburt University

OTHER

Sponsor Role: lead

Responsible Party

Hafsa Kübra

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hafsa Kübra Işık, Research Assistant, MSc

Role: CONTACT

hafsakubra@yahoo.com

+90 546 540 44 22

Other Identifiers

14219

Identifier Type: -

Identifier Source: org_study_id