Mindfulness-based Prenatal Education on Women

NCT04693130 | Completed DMC

• 1 other identifier: 108-E-14
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the differences between stress, anxiety, depression, mindfulness, mother and infants bonding, salivary amylase activity, and postnatal maternal outcomes for prenatal mental disorders in women with mindfulness prenatal education program

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• stress

  Perceived stress scale, that was 10 items to determine the self-perceived levels of unpredictability, lack of control, and burden during the last month of pregnancy. Responses are rated from 0 (never) to 4 (very often), with higher scores corresponding to higher perceived stress

  baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

Secondary Outcomes (1)

• depression

  baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

Other Outcomes (3)

• mindfulness

  baseline , and at eight weeks (after the intervention), 36 weeks of gestation, and the follow-up at 2 , 4 months postpartum

• anxiety

  baseline , and at eight weeks (after the intervention), 36 weeks of gestation.

• bonding

  the follow-up at 2 , 4 months postpartum.

Study Arms (2)

Mindfulness-based prenatal 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: Mindfulness-based prenatal education

Hospital-based antenatal education

PLACEBO COMPARATOR

Hospital-based antenatal education program.

Behavioral: Hospital-based antenatal care

Interventions

Mindfulness-based prenatal education BEHAVIORAL

Mindfulness-based prenatal education involves mindfulness breathing and other skills with mindfulness meditations.

Mindfulness-based prenatal education

Hospital-based antenatal care BEHAVIORAL

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

Hospital-based antenatal education

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects were at the age over 20
• Could speak and read Chinese fluently
• Willing and be ale to attend the education program

You may not qualify if:

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

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Wan-Lin Pan

Taipei, 114, Taiwan

Location

Related Publications (1)

• Pan WL, Lin LC, Kuo LY, Chiu MJ, Ling PY. Effects of a prenatal mindfulness program on longitudinal changes in stress, anxiety, depression, and mother-infant bonding of women with a tendency to perinatal mood and anxiety disorder: a randomized controlled trial. BMC Pregnancy Childbirth. 2023 Jul 31;23(1):547. doi: 10.1186/s12884-023-05873-2.

  PMID: 37525110 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Wan-Lin Pan, PHD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nursing department

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: January 5, 2021
• Study Start: December 24, 2020
• Primary Completion: March 3, 2022
• Study Completion: February 3, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)