NCT04214431

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
404

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

3.2 years

First QC Date

December 20, 2019

Last Update Submit

December 31, 2019

Conditions

Fear of Childbirth

Keywords

fear of childbirth, pregnancy, childbirth education,

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (10)

  • Anxiety

    pregnancy 12-24 weeks

  • Anxiety

    pregnancy 32-36 weeks

  • Anxiety

    postpartum 1 week

  • Depression

    pregnancy 12-24 weeks

  • Depression

    pregnancy 32-36 weeks

  • +5 more secondary outcomes

Study Arms (2)

Mindfulness-Based Childbirth Education

EXPERIMENTAL

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

Behavioral: Mindfulness-Based Childbirth Education

Control group

NO INTERVENTION

Women in the control group received standardized care.

Interventions

Mindfulness-Based Childbirth EducationBEHAVIORAL

8-week mindfulness-based childbirth education

Mindfulness-Based Childbirth Education

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • aged of 20 years or greater;
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 34231203DERIVED

Study Officials

  • Shu-Yu Kuo, Ph.D.

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2019

First Posted

January 2, 2020

Study Start

December 7, 2015

Primary Completion

February 23, 2019

Study Completion

December 20, 2019

Last Updated

January 3, 2020

Record last verified: 2019-12

Locations

TW(1)