Reducing Fear of Childbirth Among Pregnant Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

404 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-07

Study Completion Date

2019-12-20

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.

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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.

Conditions

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Fear of Childbirth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mindfulness-Based Childbirth Education

Women in the experimental group received eight week mindfulness-based childbirth education program delivered one class each week.

Group Type EXPERIMENTAL

Mindfulness-Based Childbirth Education

Intervention Type BEHAVIORAL

8-week mindfulness-based childbirth education

Control group

Women in the control group received standardized care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-Based Childbirth Education

8-week mindfulness-based childbirth education

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes