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NCT Number: NCT04214431

Reducing Fear of Childbirth Among Pregnant Women

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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Key information

Conditions

Fear of Childbirth

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University, Taiwan, R.O.C.

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Childbirth Education

Behavioral

8-week mindfulness-based childbirth education

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Anxiety

    Time frame: pregnancy 12-24 weeks

    Anxiety measure by State-Trait Anxiety Inventory, STAI

  2. Anxiety

    Time frame: pregnancy 32-36 weeks

    Anxiety measure by State-Trait Anxiety Inventory, STAI, with an overall score ranging 20,80. A higher score indicates higher anxiety.

  3. Anxiety

    Time frame: postpartum 1 week

    Anxiety measure by State-Trait Anxiety Inventory, STAI, with an overall score ranging 20,80. A higher score indicates higher anxiety.

  4. Depression

    Time frame: pregnancy 12-24 weeks

    Depression measure by Edinburgh Postnatal Depression Scale, EPDS, , with a total score ranging 0,30. A higher score represents a higher level of depression.

  5. Depression

    Time frame: pregnancy 32-36 weeks

    Depression measure by Edinburgh Postnatal Depression Scale, EPDS, , with a total score ranging 0,30. A higher score represents a higher level of depression.

  6. Depression

    Time frame: 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.

  7. Mindfulness

    Time frame: pregnancy 12-24 weeks

    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.

  8. Mindfulness

    Time frame: pregnancy 32-36 weeks

    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.

  9. Mindfulness

    Time frame: 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.

  10. Birth outcomes

    Time frame: postpartum 1 week

    To analyze the mode of delivery, including vaginal delivery or cesarean delivery.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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