CClinicalTrials.gg
Not yet recruitingNCT06956898Updated May 4, 2025

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

An interventional study of Mindfulness Training and Haptonomy Training in Fear of Childbirth, Haptonomy and Mindfulness, sponsored by Bayburt University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by Bayburt University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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".

02

Conditions studied

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

Keywords

  • Attachment
  • Self-Efficacy
  • Mindfulness
  • Haptonomy
  • Fear of Childbirth
03

In context

Lead sponsor

Bayburt University is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
225 participants (estimated)

Study arms

  • Experimental
    Mindfulness Group

    Providing mindfulness training

    Other: Mindfulness Training

  • Experimental
    Haptonomy Group

    Providing haptonomy training

    Other: Haptonomy Training

  • No intervention
    Control Group

    No intervention will be applied to the control group.

Interventions

  • OtherMindfulness Training

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

  • OtherHaptonomy Training

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"

  2. 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)

    Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"

  3. 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)

    Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"

  4. 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)

    Time frame: "Baseline (28th week of pregnancy)" and "Post-test immediately after the training" and "Post-test 2 weeks after the training"

Other outcomes

  1. 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)

    Time frame: "Baseline (28th week of pregnancy)"

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — The research is still in the implementation phase.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06956898
Lead sponsor
Bayburt University
Responsible party
Hafsa Kübra (Research Assistant, Ataturk University) — Principal investigator
First posted
May 4, 2025
Start date
May 2025 (estimated)
Primary completion
Sep 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 4, 2025

Study contacts

Hafsa Kübra Işık, Research Assistant, MSc
Contact
hafsakubra@yahoo.com
+90 546 540 44 22

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion