Reducing Fear of Childbirth Among Pregnant Women

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

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.

Study Overview

• Status: Completed
• Conditions: Fear of Childbirth
• Intervention / Treatment: Behavioral: Mindfulness-Based Childbirth Education

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 Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Shu-Yu Kuo, Ph.D., Taipei Medical University

Publications and helpful links

General Publications

• O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7:CD013321. doi: 10.1002/14651858.CD013321.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2015
• Primary Completion (Actual): February 23, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: fear of childbirth, pregnancy, childbirth education,
• Other Study ID Numbers: N201508025