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

NCT07320794 | Completed

• 1 other identifier: Interventional(clinical) Trial
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fear of Childbirth; Mindfulness

Keywords

Mindfulness; Fear of childbirth; Birth satisfaction; Midwifery, Education

Outcome Measures

Primary Outcomes (4)

• 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: 37-40 gestational weeks]

• 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: 28-32 gestational weeks

• 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: 7-15 day after the birth]

• 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: 7-15 days after birth

Secondary Outcomes (1)

• The Mindfulness Scale

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

Study Arms (2)

Behavioral: Intervention group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Mindfulness-Based Childbirth Education BEHAVIORAL

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

Behavioral: Intervention group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (2)

Aydin Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Aydin, Aydın, 09100, Turkey (Türkiye)

Location

Aydin Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (1)

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

  BACKGROUND

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: January 6, 2025
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after publication
• Access Criteria: elevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (2)