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CompletedNCT07320794Updated Jan 9, 2026

The Effect of Mindful Awareness on Fear and Satisfaction of Childbirth.

An interventional study of Mindfulness-Based Childbirth Education in Fear of Childbirth and Mindfulness, sponsored by Aydin Adnan Menderes University. Completed at 2 sites in Turkey (Türkiye). Open to female participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Aydin Adnan Menderes University · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Jan 2025, registered Dec 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study summary

The aim of this study is to conduct a randomized controlled experimental study to determine the effect of online mindfulness-based childbirth anxiety training on childbirth anxiety and birth satisfaction in pregnant women.

Read the detailed description

The aim of this study is to conduct a randomized controlled experimental study to determine the effect of online mindfulness-based childbirth anxiety training on childbirth anxiety and birth satisfaction in pregnant women.

Detailed Description: Childbirth anxiety is a common problem among women and affects their health and well-being before, during, and after pregnancy.

This problem can lead to negative pregnancy outcomes and can also cause psychological problems for the woman.

Childbirth anxiety can also affect the choice of delivery method and lead to an increase in cesarean section rates.

Healthcare services provided by midwives and other healthcare professionals during pregnancy and childbirth have the power to reduce or increase childbirth anxiety.

The most important midwifery intervention that can be used to reduce childbirth anxiety is counseling. The importance of childbirth anxiety for the midwifery profession is clearly evident from the fact that women prefer more interventions during childbirth. Large epidemiological studies provide good evidence that women experiencing childbirth anxiety prefer interventions during childbirth. When mindfulness training is examined in general, it is seen that mindfulness-based interventions can be effective in increasing positive emotions and decreasing negative emotions. The use of mindfulness-based interventions is increasing day by day, and their clinical benefits are being proven by studies. In light of these studies, it can be said that the method can be used in women not only to reduce stress but also as an effective method with physiological benefits. It is necessary to increase basic mindfulness training for pregnant women, to include midwives in mindfulness-based interventions, to develop intervention programs for women's specific life stages by ensuring necessary collaborations, and to evaluate the results of these programs. Studies have indicated that mindfulness training during counseling increases women's self-esteem. With mindfulness training, pregnant women's sense of control and self-confidence during childbirth can be increased, and birth outcomes can be improved positively. This study was conducted to determine the effect of mindfulness-based childbirth fear management training given to women on childbirth fear and birth satisfaction. The hypothesis that there was no difference in the mean childbirth fear and satisfaction scores between the intervention and control groups after the intervention was tested.

02

Conditions studied

  • Fear of Childbirth
  • Mindfulness

Keywords

  • Mindfulness
  • Fear of childbirth
  • Birth satisfaction
  • Midwifery, Education
03

In context

Lead sponsor

Aydin Adnan Menderes University is the lead sponsor of 236 studies on the registry; 54 are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Between 20-35 years of age,
  • At least a secondary school graduate,
  • Residing within the borders of Aydın province,
  • Being between 28-32 weeks pregnant according to the last menstrual period,
  • Having no obstacles to giving birth vaginally,
  • Having decided to give birth vaginally,
  • Having the conditions to receive online training (internet, computer, smartphone, etc.),
  • Being able to speak and understand Turkish,
  • Pregnant women who are having their first pregnancy will be included.

Exclusion criteria

Exclusion Criteria:

    • Women whose current pregnancy is high-risk (such as multiple pregnancy, preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios),

      • Women diagnosed with mental illnesses (depression, anxiety disorder, schizophrenia, bipolar disorder, etc.),
      • All pregnant women who have undergone infertility treatment and become pregnant will not be included in the study.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Behavioral: Intervention group

    The mindfulness training was conducted over three weeks, with two sessions per week, for a total of six sessions. Pregnant women were given brochures and booklets prepared by the researcher, appropriate to the training content, before the training (Appendix 13). Pregnant women in the intervention group received training reminders via text message the day before the training and again via text message a few hours before the training, sometimes by phone. The training was conducted at times convenient for the pregnant women, with each session lasting 40-45 minutes. At least two weeks after the mindfulness training, data were collected online using the W-DEQ-A and mindfulness scales; those who could not be reached were administered face-to-face, and those who could not be reached were administered via text message. Between days 7 and 15 postpartum, the postpartum information form, the W-DEQ-B and mindfulness scales, and the birth satisfaction scale were administered to the women at times

    Behavioral: Mindfulness-Based Childbirth Education

  • No intervention
    control group

    No Intervention: Control group The control group continued to receive the routine care

Interventions

  • BehavioralMindfulness-Based Childbirth Education

    The intervention consisted of a structured mindfulness-based childbirth education program delivered over three weeks, with two sessions per week (six sessions in total). Each session lasted approximately 40-45 minutes. The program aimed to reduce fear of childbirth and improve childbirth satisfaction. Educational materials were provided to participants, and reminder messages were sent before each session.

    Also known as: Intervention group

06

What researchers measure

Primary outcomes

  1. 2. Fear of childbirth after intervention

    2\. Fear of childbirth after intervention assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth. \[Time Frame: 36-38 gestational weeks\]

    Time frame: [Time Frame: 37-40 gestational weeks]

  2. Fear of childbirth before intervention

    . Fear of childbirth before intervention assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version A. This instrument contains questions on women's prenatal expectations to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel before their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version A is based on a 6-point Likert scale numbered 0-5. Zero corresponds to the response, "Totally" and five means "none." The minimum possible score on the scale is a "0"; maximum is 165. Higher scores indicate greater levels of Fear of Childbirth.

    Time frame: [Time Frame: 28-32 gestational weeks

  3. Fear of childbirth after birth

    Fear of childbirth after birth assessed using the Wijma Delivery Expectancy/Experience Questionnaire- Version B. This instrument contains questions on women's postpartum experiences to measure the nature of the fear experienced during and following childbirth. The instrument makes it possible to identify the nature of the fear of childbirth women feel after their delivery. This scale contain 33 questions. Wijma Delivery Expectancy/Experience Questionnaire- Version-B is based on a 6- point Likert scale where the responses are numbered from 1-6 and one corresponds to the response, "Totally" and six means "none." The total possible score on the scale varies between 33-198. Higher scores indicate greater levels of Fear of Childbirth.

    Time frame: [Time Frame: 7-15 day after the birth]

  4. Birth satisfaction scale.

    Birth satisfaction scale. Each item is rated on a four-point Likert scale (1=strongly agree, 2=partially agree, 3=somewhat agree, 4=strongly disagree). A minimum score of 10 and a maximum score of 40 are accepted. There is no cutoff point on the scale. A high score is associated with low birth satisfaction. \[Time Frame: 7-15 days after birth\]

    Time frame: [Time Frame: 7-15 days after birth

Secondary outcomes

  1. The Mindfulness Scale

    The Mindfulness Scale is a 15-item scale that measures the general tendency to be aware of and attentive to present experiences in daily life. The scale has a single-factor structure and gives a single total score. Higher scores on the scale indicate higher mindfulness. The scale is a 6-point Likert-type scale (Almost always, most of the time, sometimes, rarely, quite rarely, almost never).

    Time frame: Time Frame: 28-32 gestational weeks Time Frame: 37-40 gestational weeks Time Frame: 7-15. day after birth

07

Study locations

2 sites
  • Aydin Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
    Aydin, Aydın 09100, Turkey (Türkiye)
  • Aydin Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
    Aydin, 09100, Turkey (Türkiye)
08

References and documents

Publications

  • https://earsiv.odu.edu.tr/jspui/bitstream/11489/3915/1/10435776.pdf

Related links

Individual participant data

Plan to share: Yes

Supporting information: Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07320794
Lead sponsor
Aydin Adnan Menderes University
Responsible party
Funda ÇINAR SAY (Principal Investigator, Aydin Adnan Menderes University) — Principal investigator
First posted
Jan 6, 2026
Start date
Jan 6, 2025
Primary completion
Jul 10, 2025
Completion
Jul 10, 2025
Last update
Jan 9, 2026

Oversight

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

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