Diaphragmatic Breathing Training on Postpartum Anxiety

Not Applicable

• Conditions: Postpartum Anxiety
• Interventions: Behavioral: Experimental group

• Registration Number: NCT05474248
• Lead Sponsor: Ministry of Science and Technology, Taiwan

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

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Study Timeline

• Study Start: 2021-02-28
• Primary Completion: 2021-04-12
• Status Verified: 2022-07
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Study First Posted: 2022-07-26
• Last Update Posted: 2022-07-26
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diaphragmatic Breathing Training	Experimental group	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.

Primary Outcome Measures

Name	Time	Method
Postpartum anxiety	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 Outcome Measures

Name	Time	Method
Heart rate	Post-test: Change from baseline heart rate at 4 weeks postpartum	Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for heart rate
Blood pressure	Post-test: Change from baseline heart rate at 4 weeks postpartum	Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure

Trial Locations

Locations (1)

Taipei Tzu Chi Hospital; 🇨🇳 Taipei, Xindian Dist, Taiwan