Reducing Fear of Childbirth Among Pregnant Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fear of Childbirth

Intervention / Treatment
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* Behavioral: Mindfulness-Based Childbirth Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Childbirth Education<br>Women in the experimental group received eight week mindfulness-based childbirth education program delivered one class each week. | Behavioral: Mindfulness-Based Childbirth Education<br>* 8-week mindfulness-based childbirth education<br>|
| No Intervention: Control group<br>Women in the control group received standardized care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety measure by State-Trait Anxiety Inventory, STAI | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | postpartum 1 week | 
| Birth outcomes | To analyze the mode of delivery, including vaginal delivery or cesarean delivery. | postpartum 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fear of childbirth, pregnancy, childbirth education,