Reducing Fear of Childbirth Among Pregnant Women

Fear of Childbirth Clinical Trial

Official title:

Reducing Fear of Childbirth Among Pregnant Women: Women's Lived Experience, Predictors, and Effects of Mindfulness-based Childbirth Education

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214431
• Other study ID #: N201508025
• Status: Completed
• Phase: N/A
• Start date: December 7, 2015
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2019
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: December 20, 2019
• Est. primary completion date: February 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. aged of 20 years or greater;

2. 12-25 week of gestation, Singleton pregnancy;

3. able to communicate with Mandarin or Taiwanese;

4. High levels of fear of Childbirth (greater 9 or above on Numeric Rating Scale).

Exclusion Criteria:

1. Current having psychological diseases or substance abuse, unable to follow the mindfulness-based childbirth education;

2. unable to attend every class or each assessment;

3. received any cognitive training in past one year.

Related Conditions & MeSH terms

• Fear of Childbirth

Intervention

Behavioral:
• Mindfulness-Based Childbirth Education
8-week mindfulness-based childbirth education

Locations

Country	Name	City	State
Taiwan	Taipei Medical University, Taiwan, R.O.C.	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pregnancy 12-24 weeks
Primary	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.	pregnancy 32-36 weeks
Primary	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.	postpartum 1 week
Secondary	Anxiety	Anxiety measure by State-Trait Anxiety Inventory, STAI	pregnancy 12-24 weeks
Secondary	Anxiety	Anxiety measure by State-Trait Anxiety Inventory, STAI, with an overall score ranging 20,80. A higher score indicates higher anxiety.	pregnancy 32-36 weeks
Secondary	Anxiety	Anxiety measure by State-Trait Anxiety Inventory, STAI, with an overall score ranging 20,80. A higher score indicates higher anxiety.	postpartum 1 week
Secondary	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.	pregnancy 12-24 weeks
Secondary	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.	pregnancy 32-36 weeks
Secondary	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.	postpartum 1 week
Secondary	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.	pregnancy 12-24 weeks
Secondary	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.	pregnancy 32-36 weeks
Secondary	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.	postpartum 1 week
Secondary	Birth outcomes	To analyze the mode of delivery, including vaginal delivery or cesarean delivery.	postpartum 1 week