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

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 Overview

• Status: Not yet recruiting
• Conditions: Fear of Childbirth; Mindfulness; Self-Efficacy; Attachment; Haptonomy
• Intervention / Treatment: Other: Mindfulness Training; Other: Haptonomy Training

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hafsa Kübra Işık, Research Assistant, MSc; Phone Number: +90 546 540 44 22; Email: hafsakubra@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No intervention will be applied to the control group.
Experimental: Mindfulness Group; Providing mindfulness training	Other: Mindfulness Training; Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.
Experimental: Haptonomy Group; Providing haptonomy training	Other: Haptonomy Training; Primiparous pregnant women in the experimental (mindfulness) group will be given training for 8 weeks starting from the 28th week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	"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)	"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)	"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)	"Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Personal Information Form	This form was developed by the researchers based on the relevant literature. It is used to collect the socio-demographic and obstetric information of the participants and their perceptions about birth. Data obtained will be used to describe sample characteristics and for subgroup analysis purposes. It is not considered a primary or secondary outcome measure. The topics covered are; Age group, Educational status, Employment status, Income level, Last menstrual period, Week of gestation, Whether the pregnancy was planned or not, Access to prenatal care, Labor pain and fear of childbirth, Attitudes towards awareness, haptonomy and perceived effectiveness of prenatal care in reducing fear of childbirth Participants respond using multiple choice or yes/no options. Responses will be analyzed descriptively and used to investigate associations with primary outcomes where appropriate. Baseline (28th week of pregnancy)	"Baseline (28th week of pregnancy)"

Collaborators and Investigators

• Sponsor: Bayburt University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; Self-Efficacy; Attachment; Fear of Childbirth; Haptonomy
• Other Study ID Numbers: 14219

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The research is still in the implementation phase.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No