Fear of ChildbirthNCT07320794
The Effect of Mindful Awareness on Fear and Satisfaction of Childbirth.
A study testing Mindfulness-Based Childbirth Education in people with Fear of Childbirth and Mindfulness, run by Aydin Adnan Menderes University at 2 sites in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth, Mindfulness
- What is being tested?
- Mindfulness-Based Childbirth Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- • 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aydin Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
Aydin, Aydın, 09100
Aydin Adnan Menderes University, Faculty of Health Sciences, Division of Midwifery
Aydin, 09100
About this study
Official title: The Effect of Mindfulness Training on Coping With Fear of Birth Training Applied Online to Pregnant Women on Fear of Birth and Birth Satisfaction
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.
- Conditions
- Fear of Childbirth, Mindfulness
- Being tested
- Mindfulness-Based Childbirth Education
- Keywords
- Mindfulness, Fear of childbirth, Birth satisfaction, Midwifery, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Childbirth EducationBehavioural
Also called Intervention group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Mindfulness-Based Childbirth Education |
| control group | No intervention | No Intervention: Control group The control group continued to receive the routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
2. Fear of childbirth after intervention
- 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]
Measured: [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.
Measured: [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.
Measured: [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]
Measured: [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).
Measured: Time Frame: 28-32 gestational weeks Time Frame: 37-40 gestational weeks Time Frame: 7-15. day after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start6 Jan 2025
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Funda ÇINAR SAY, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320794
- Sponsor's protocol ID
- Interventional(clinical) Trial
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
https://earsiv.odu.edu.tr/jspui/bitstream/11489/3915/1/10435776.pdf
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness Training on Coping With Fear of Birth Training Applied Online to Pregnant Women on Fear of Birth and Birth Satisfaction
- ClinicalTrials.gov ID
- NCT07320794
- Acronym / sponsor ID
- Interventional(clinical) Trial
- Conditions
- Fear of Childbirth, Mindfulness
- Keywords
- Mindfulness, Fear of childbirth, Birth satisfaction, Midwifery, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Intervention group | Experimental | Behavioral: Mindfulness-Based Childbirth EducationThe 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 |
| control group | No intervention | –No Intervention: Control group The control group continued to receive the routine care |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (3 listed)
- • Women whose current pregnancy is high-risk (such as multiple pregnancy, preeclampsia, diabetes, heart disease, placenta previa, oligohydramnios),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Childbirth EducationAlso: Intervention groupThe 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. | Behavioural | Behavioral: Intervention group |
Primary outcome
2. Fear of childbirth after intervention
Time frame: [Time Frame: 37-40 gestational weeks]
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]
Fear of childbirth before intervention
Time frame: [Time Frame: 28-32 gestational weeks
. 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.
Fear of childbirth after birth
Time frame: [Time Frame: 7-15 day after the 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.
Birth satisfaction scale.
Time frame: [Time Frame: 7-15 days after birth
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]
1 secondary outcome
The Mindfulness Scale
Time frame: Time Frame: 28-32 gestational weeks Time Frame: 37-40 gestational weeks Time Frame: 7-15. day after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Backgroundhttps://earsiv.odu.edu.tr/jspui/bitstream/11489/3915/1/10435776.pdf
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Childbirth Education in people with Fear of Childbirth and Mindfulness, run by Aydin Adnan Menderes University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2. Fear of childbirth after intervention (time frame: [Time Frame: 37-40 gestational weeks]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07320794, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.