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Mindfulness-Based Childbirth and Parenting Education on Pregnant Women

Primary Purpose

Stress, Psychological, Pregnancy Related

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MBCP education
Hospital-based antenatal education
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MBCP education

    Hospital-based antenatal education

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    postpartum medical records
    This instrument was to explore whether recording of pregnancy outcome in medical records
    change of symptoms with depression and anxiety
    Self reported the symptoms with depression and anxiety change from baseline to 6 months after childbirth using the Edinburgh Postnatal Depression Scale
    change of the childbirth self-efficacy
    Self reported the childbirth self-efficacy change from baseline to 6 months after childbirth using the Childbirth Self-Efficacy Inventory
    change of mindfulness
    Self reported the mindfulness change from baseline to 6 months after childbirth using Five Factor Mindfulness Questionnaire

    Full Information

    First Posted
    May 27, 2017
    Last Updated
    June 10, 2017
    Sponsor
    National Taipei University of Nursing and Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03185910
    Brief Title
    Mindfulness-Based Childbirth and Parenting Education on Pregnant Women
    Official Title
    The Efficacy of a Mindfulness-Based Childbirth and Parenting Education on Pregnant Women's Childbirth Self-efficacy, Psychological Health and Maternal Outcomes: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 3, 2016 (Actual)
    Primary Completion Date
    December 2, 2017 (Anticipated)
    Study Completion Date
    February 28, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National Taipei University of Nursing and Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Being a mother is a huge change for women, and she will undergo a high degree of change and a strong threat in this transformation process. The purpose of this study is to explore the efficacy of a Mindfulness-Based Childbirth and Parenting(MBCP) Education Program on prenatal stress, depression, mindfulness, childbirth self-efficacy, and postnatal maternal outcomes. Randomized Controlled Trial comparing two education programs with health and singleton pregnant women is run by the Random Allocation Software (Saghaei, 2004). Use the G-Power 3.1.9 windows: repeated measures and between factors among two groups to calculate the number of samples, and setting the power = .8, α = .05, effect size = .25. The estimated number of samples may be lost 20%, total 104 samples ( 52 samples in each group). The protocol for the study used MBCP education, this program helps participants practice in the present moment, so that they may develop more confidence and well-being during pregnancy. The MBCP course is held for 3 hrs once a week for 8 weeks. They also had the home practice of 30 minutes a day with a DVD for the experimental group. The control group attending a hospital-based antenatal education program for 2 hrs once a month for 2 months from hospital staff nurses in all aspects of pregnancy, childbirth and postpartum. This study uses a standard verbal script to the eligible participants who were volunteers of pregnant women in the waiting room of metropolitan hospital in Taiwan.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Psychological, Pregnancy Related

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MBCP education
    Arm Type
    Experimental
    Arm Description
    The intervention includes 3-hour classes per week during the duration of eight weeks and a 7- hour silent meditation practice as well.
    Arm Title
    Hospital-based antenatal education
    Arm Type
    Placebo Comparator
    Arm Description
    Hospital-based antenatal education program will be held 2 hrs once a month for 2 months.
    Intervention Type
    Behavioral
    Intervention Name(s)
    MBCP education
    Intervention Description
    MBCP education involves mindfulness breathing and other skills with mindfulness meditations.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Hospital-based antenatal education
    Intervention Description
    Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.
    Primary Outcome Measure Information:
    Title
    change of prenatal and postnatal stress
    Description
    Self reported the perception of stress change from baseline to 6 months after childbirth using The Perceived Stress Scale
    Time Frame
    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
    Secondary Outcome Measure Information:
    Title
    postpartum medical records
    Description
    This instrument was to explore whether recording of pregnancy outcome in medical records
    Time Frame
    After the childbirth within 24 hours will be collected
    Title
    change of symptoms with depression and anxiety
    Description
    Self reported the symptoms with depression and anxiety change from baseline to 6 months after childbirth using the Edinburgh Postnatal Depression Scale
    Time Frame
    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
    Title
    change of the childbirth self-efficacy
    Description
    Self reported the childbirth self-efficacy change from baseline to 6 months after childbirth using the Childbirth Self-Efficacy Inventory
    Time Frame
    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth
    Title
    change of mindfulness
    Description
    Self reported the mindfulness change from baseline to 6 months after childbirth using Five Factor Mindfulness Questionnaire
    Time Frame
    Baseline, T1: After 2-month intervention, T2: At 36th week pregnancy, T3: 6 months after childbirth

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Taking medication for diagnosing mental illness With complicated or high-risk pregnancies
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wan-Lin Pan, MD
    Organizational Affiliation
    National Taipei University of Nursing and Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31601170
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Mindfulness-Based Childbirth and Parenting Education on Pregnant Women

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