Reducing Fear of Childbirth Among Pregnant Women

Not Applicable

Completed

• Conditions: Fear of Childbirth
• Interventions: Behavioral: Mindfulness-Based Childbirth Education

• Registration Number: NCT04214431
• Lead Sponsor: Taipei Medical University

Brief 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.

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 Timeline

• Study Start: 2015-12-07
• Primary Completion: 2019-02-23
• Status Verified: 2019-12
• Study Completion: 2019-12-20
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-27
• Last Update Submitted: 2019-12-31
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 404

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Childbirth Education	Mindfulness-Based Childbirth Education	Women in the experimental group received eight week mindfulness-based childbirth education program delivered one class each week.

Primary Outcome Measures

Name	Time	Method
Fear of childbirth	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety	postpartum 1 week	Anxiety measure by State-Trait Anxiety Inventory, STAI, with an overall score ranging 20,80. A higher score indicates higher anxiety.
Mindfulness	postpartum 1 week	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.
Depression	postpartum 1 week	Depression measure by Edinburgh Postnatal Depression Scale, EPDS, , with a total score ranging 0,30. A higher score represents a higher level of depression.
Birth outcomes	postpartum 1 week	To analyze the mode of delivery, including vaginal delivery or cesarean delivery.

Trial Locations

Locations (1)

Taipei Medical University, Taiwan, R.O.C.; 🇨🇳 Taipei, Taiwan