Fear of ChildbirthNCT04214431
Reducing Fear of Childbirth Among Pregnant Women
A study testing Mindfulness-Based Childbirth Education in people with Fear of Childbirth, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Pregnant women often experience fear of childbirth or anxiety toward the labor pain or uncertainties associated with labor process. To develop and evaluate the efficacy of childbirth educational interventions on reduction of fear or anxiety is an important issue in maternal health care. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- 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
- 404 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Dec 2015to 20 Dec 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged of 20 years or greater;
- 12-25 week of gestation, Singleton pregnancy;
- able to communicate with Mandarin or Taiwanese;
- High levels of fear of Childbirth (greater 9 or above on Numeric Rating Scale).
Who cannot join
- Current having psychological diseases or substance abuse, unable to follow the mindfulness-based childbirth education;
- unable to attend every class or each assessment;
- received any cognitive training in past one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Fear of Childbirth Among Pregnant Women: Women's Lived Experience, Predictors, and Effects of Mindfulness-based Childbirth Education
Pregnant women often experience fear of childbirth or anxiety toward the labor pain or uncertainties associated with labor process. To develop and evaluate the efficacy of childbirth educational interventions on reduction of fear or anxiety is an important issue in maternal health care.
Read the detailed description
Fear of childbirth is a common clinical problem among perinatal women and link to adverse health effects on mother's and offspring's well-being. Recently, reducing the childbirth fear becomes a highly important maternity care issues as a result of the fact that the birth rate has been declining rapidly as well as Cesarean rate increased steadily. However, the studies on fear of childbirth among perinatal population in Taiwan were limited. In this proposal the investigators plan to conduct a randomized controlled study examining the effects of mindfulness-based childbirth education. In the randomized controlled study, women will be recruited and randomized into the experiment group (receiving mindfulness-based childbirth education and traditional childbirth education),or will be allocated in the control group receiving traditional childbirth education. Intention-to-treat analysis as well as mixed regression modeling will be used to estimate the effectiveness of the interventions.
- Conditions
- Fear of Childbirth
- Being tested
- Mindfulness-Based Childbirth Education
- Keywords
- fear of childbirth, pregnancy, childbirth education,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Childbirth EducationBehavioural
8-week mindfulness-based childbirth education
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Childbirth Education | Experimental | Women in the experimental group received eight week mindfulness-based childbirth education program delivered one class each week. Receives: Behavioral: Mindfulness-Based Childbirth Education |
| Control group | No intervention | Women in the control group received standardized care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of childbirth
Fear of childbirth measure by the Wijma Delivery Expectancy/ Experience Questionnaires, W-DEQ with total score ranging between 0~165. The high score indicated higher levels of childbirth fear.
Measured: pregnancy 12-24 weeks
Fear of childbirth
Fear of childbirth measure by the Wijma Delivery Expectancy/ Experience Questionnaires, W-DEQ with total score ranging 0-165. The higher score indicated higher level of childbirth fear.
Measured: pregnancy 32-36 weeks
Fear of childbirth
Fear of childbirth measure by the Wijma Delivery Expectancy/ Experience Questionnaires, W-DEQ, with total score ranging 0-165. The higher score indicated the higher level of childbirth fear.
Measured: postpartum 1 week
Secondary outcomes (10)
Anxiety
Anxiety measure by State-Trait Anxiety Inventory, STAI
Measured: pregnancy 12-24 weeks
Anxiety
Anxiety measure by State-Trait Anxiety Inventory, STAI, with an overall score ranging 20,80. A higher score indicates higher anxiety.
Measured: pregnancy 32-36 weeks
Anxiety
Anxiety measure by State-Trait Anxiety Inventory, STAI, with an overall score ranging 20,80. A higher score indicates higher anxiety.
Measured: postpartum 1 week
Depression
Depression measure by Edinburgh Postnatal Depression Scale, EPDS, , with a total score ranging 0,30. A higher score represents a higher level of depression.
Measured: pregnancy 12-24 weeks
Depression
Depression measure by Edinburgh Postnatal Depression Scale, EPDS, , with a total score ranging 0,30. A higher score represents a higher level of depression.
Measured: pregnancy 32-36 weeks
Depression
Depression measure by Edinburgh Postnatal Depression Scale, EPDS, , with a total score ranging 0,30. A higher score represents a higher level of depression.
Measured: postpartum 1 week
Mindfulness
Mindfulness measure by Chinese Version Mindful Attention Awareness Scale (CMAAS), with a total score ranging 15-90, the higher score and the high levels of mindfulness.
Measured: pregnancy 12-24 weeks
Mindfulness
Mindfulness measure by Chinese Version Mindful Attention Awareness Scale, CMAAS, with a total score ranging from 15-90, the higher score the high levels of mindfulness.
Measured: pregnancy 32-36 weeks
Mindfulness
Mindfulness measure by Chinese Version Mindful Attention Awareness Scale, CMAAS, with a total score ranging 15-90, and the higher the score, the higher levels of mindfulness.
Measured: postpartum 1 week
Birth outcomes
To analyze the mode of delivery, including vaginal delivery or cesarean delivery.
Measured: postpartum 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start7 Dec 2015
- Primary completion23 Feb 2019
- Study completion20 Dec 2019
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 Taipei Medical 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shu-Yu Kuo, Ph.D., Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214431
- Sponsor's protocol ID
- N201508025
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
Publications
O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
PubMed 34231203
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Fear of Childbirth Among Pregnant Women: Women's Lived Experience, Predictors, and Effects of Mindfulness-based Childbirth Education
- ClinicalTrials.gov ID
- NCT04214431
- Acronym / sponsor ID
- N201508025
- Conditions
- Fear of Childbirth
- Keywords
- fear of childbirth, pregnancy, childbirth education,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 23 Feb 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 2 Jan 2020 (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.
Pregnant women often experience fear of childbirth or anxiety toward the labor pain or uncertainties associated with labor process. To develop and evaluate the efficacy of childbirth educational interventions on reduction of fear or anxiety is an important issue in maternal health care.
Detailed description
Fear of childbirth is a common clinical problem among perinatal women and link to adverse health effects on mother's and offspring's well-being. Recently, reducing the childbirth fear becomes a highly important maternity care issues as a result of the fact that the birth rate has been declining rapidly as well as Cesarean rate increased steadily. However, the studies on fear of childbirth among perinatal population in Taiwan were limited. In this proposal the investigators plan to conduct a randomized controlled study examining the effects of mindfulness-based childbirth education. In the randomized controlled study, women will be recruited and randomized into the experiment group (receiving mindfulness-based childbirth education and traditional childbirth education),or will be allocated in the control group receiving traditional childbirth education. Intention-to-treat analysis as well as mixed regression modeling will be used to estimate the effectiveness of the interventions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Childbirth Education | Experimental | Behavioral: Mindfulness-Based Childbirth EducationWomen in the experimental group received eight week mindfulness-based childbirth education program delivered one class each week. |
| Control group | No intervention | –Women in the control group received standardized care. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged of 20 years or greater;
- 12-25 week of gestation, Singleton pregnancy;
- able to communicate with Mandarin or Taiwanese;
- High levels of fear of Childbirth (greater 9 or above on Numeric Rating Scale).
Key exclusion criteria (3 listed)
- Current having psychological diseases or substance abuse, unable to follow the mindfulness-based childbirth education;
- unable to attend every class or each assessment;
- received any cognitive training in past one year.
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 Education8-week mindfulness-based childbirth education | Behavioural | Mindfulness-Based Childbirth Education |
Primary outcome
Fear of childbirth
Time frame: pregnancy 12-24 weeks
Fear of childbirth measure by the Wijma Delivery Expectancy/ Experience Questionnaires, W-DEQ with total score ranging between 0~165. The high score indicated higher levels of childbirth fear.
Fear of childbirth
Time frame: pregnancy 32-36 weeks
Fear of childbirth measure by the Wijma Delivery Expectancy/ Experience Questionnaires, W-DEQ with total score ranging 0-165. The higher score indicated higher level of childbirth fear.
Fear of childbirth
Time frame: postpartum 1 week
Fear of childbirth measure by the Wijma Delivery Expectancy/ Experience Questionnaires, W-DEQ, with total score ranging 0-165. The higher score indicated the higher level of childbirth fear.
10 secondary outcomes
Anxiety
Time frame: pregnancy 12-24 weeks
Anxiety
Time frame: pregnancy 32-36 weeks
Anxiety
Time frame: postpartum 1 week
Depression
Time frame: pregnancy 12-24 weeks
Depression
Time frame: pregnancy 32-36 weeks
Depression
Time frame: postpartum 1 week
Mindfulness
Time frame: pregnancy 12-24 weeks
Mindfulness
Time frame: pregnancy 32-36 weeks
Mindfulness
Time frame: postpartum 1 week
Birth outcomes
Time frame: postpartum 1 week
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 3 Jan 2020.
- Derived from this study: PubMed 34231203O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
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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.
Shu-Yu Kuo, Ph.D. principal investigator
Taipei Medical University
1 site 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, run by Taipei Medical University at 1 site in Taiwan.
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 4 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 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Fear of childbirth (time frame: pregnancy 12-24 weeks). The study lists 3 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 NCT04214431, 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 3 Jan 2020.