Clinical trial NCT04214431: Reducing Fear of Childbirth Among Pregnant Women
Official title: Reducing Fear of Childbirth Among Pregnant Women: Women's Lived Experience, Predictors, and Effects of Mindfulness-based Childbirth Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Childbirth
Keywords: fear of childbirth, pregnancy, childbirth education,
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 404
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fear of childbirth
timeFrame: pregnancy 12-24 weeks
measure: Fear of childbirth
timeFrame: pregnancy 32-36 weeks
measure: Fear of childbirth
timeFrame: postpartum 1 week
Secondary outcomes:
measure: Anxiety
timeFrame: pregnancy 12-24 weeks
measure: Anxiety
timeFrame: pregnancy 32-36 weeks
measure: Anxiety
timeFrame: postpartum 1 week
measure: Depression
timeFrame: pregnancy 12-24 weeks
measure: Depression
timeFrame: pregnancy 32-36 weeks
measure: Depression
timeFrame: postpartum 1 week
measure: Mindfulness
timeFrame: pregnancy 12-24 weeks
measure: Mindfulness
timeFrame: pregnancy 32-36 weeks
measure: Mindfulness
timeFrame: postpartum 1 week
measure: Birth outcomes
timeFrame: postpartum 1 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University, Taiwan, R.O.C.
Study officials:
affiliation: Taipei Medical University
name: Shu-Yu Kuo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.