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Clinical Trials/NCT05474248
NCT05474248
Unknown
Not Applicable

Effects of A Biofeedback-assisted Diaphragmatic Breathing Training on Postpartum Anxiety: A Randomized Controlled Trial

Ministry of Science and Technology, Taiwan1 site in 1 country128 target enrollmentFebruary 28, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postpartum Anxiety
Sponsor
Ministry of Science and Technology, Taiwan
Enrollment
128
Locations
1
Primary Endpoint
Postpartum anxiety
Last Updated
3 years ago

Overview

Brief Summary

This is a two-group pretest-posttest, triple-blinded and randomized controlled trial examining the effects of a biofeedback-assisted diaphragmatic breathing training on postpartum anxiety. This study will include full-term postpartum women, aged from 20 to 49, who experienced anxious symptoms with State Anxiety Inventory (A-State) scored 40 or more at the first postpartum day. Participants will be randomly assigned to either an experimental group (n = 64) or a control group (n = 64). The experimental group will undergo the diaphragmatic breathing training assisted with StressEraser to breath slowly 4-6 times per minute and practice 15 minutes twice daily. Participants in the control condition receive postpartum usual care. The outcome measures include anxiety measured by State-Trait Anxiety Inventory (STAI) and the physiological parameters expressed by blood pressure (BP) and heart rate (HR). Measurements will be taken at the first postpartum day and one month postpartum. We except this breathing training design is able to improve women's postpartum anxiety, and in turn improve their physio-psychological health, breastfeeding and baby care skills.

Detailed Description

Ditto

Registry
clinicaltrials.gov
Start Date
February 28, 2021
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Ministry of Science and Technology, Taiwan
Responsible Party
Principal Investigator
Principal Investigator

Yuh-Kae Shyu

Assistant Professor

Ministry of Science and Technology, Taiwan

Eligibility Criteria

Inclusion Criteria

  • full-term postpartum women
  • aged from 20 to 49
  • STAI-S scored 40 or more at the first postpartum day

Exclusion Criteria

  • newborn with severe illness or stillbirth
  • maternal suicide or self-harm
  • drug use: sedatives, hypnotics or antipsychotic drugs

Outcomes

Primary Outcomes

Postpartum anxiety

Time Frame: Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum

Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms

Secondary Outcomes

  • Blood pressure(Post-test: Change from baseline heart rate at 4 weeks postpartum)
  • Heart rate(Post-test: Change from baseline heart rate at 4 weeks postpartum)

Study Sites (1)

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