NCT03185910

Brief Summary

The purpose of this study is to explore the differences between stress, depression, childbirth self-efficacy, mindfulness and postnatal maternal outcomes in pregnant women with Mindfulness-Based Childbirth and Parenting education program.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

June 14, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

May 27, 2017

Last Update Submit

June 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • change of prenatal and postnatal stress

    Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale

    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth

Secondary Outcomes (4)

  • postpartum medical records

    After the childbirth within 24 hours will be collected

  • change of symptoms with depression and anxiety

    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth

  • change of the childbirth self-efficacy

    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth

  • change of mindfulness

    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth

Study Arms (2)

MBCP education

EXPERIMENTAL

The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well.

Behavioral: MBCP education

Hospital-based antenatal education

PLACEBO COMPARATOR

Hospital-based antenatal education program will be held 2 hrs once a month for 2 months.

Behavioral: Hospital-based antenatal education

Interventions

MBCP educationBEHAVIORAL

MBCP education involves mindfulness breathing and other skills with mindfulness meditations.

MBCP education

Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.

Hospital-based antenatal education

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects were pregnant from 13th to 28th weeks gestation with a singleton pregnancy
  • Subjects were at the age over 20
  • Could speak and read Chinese fluently
  • Willing and be able to attend the education program
  • Determined to have a vaginal birth

You may not qualify if:

  • Taking medication for diagnosing mental illness
  • With complicated or high-risk pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pan WL, Chang CW, Chen SM, Gau ML. Assessing the effectiveness of mindfulness-based programs on mental health during pregnancy and early motherhood - a randomized control trial. BMC Pregnancy Childbirth. 2019 Oct 10;19(1):346. doi: 10.1186/s12884-019-2503-4.

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Wan-Lin Pan, MD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing department

Study Record Dates

First Submitted

May 27, 2017

First Posted

June 14, 2017

Study Start

February 3, 2016

Primary Completion

December 2, 2017

Study Completion

February 28, 2018

Last Updated

June 14, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share