Diaphragmatic Breathing Training on Postpartum Anxiety

Study Overview
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Brief Summary
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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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Ditto

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

Conditions
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Postpartum Anxiety

Intervention / Treatment
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* Behavioral: Experimental group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diaphragmatic Breathing Training<br>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. | Behavioral: Experimental group<br>* Diaphragmatic Breathing Training<br>|
| No Intervention: Control group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum anxiety | Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms | Baseline: postpartum day 1-3 | 
| Postpartum anxiety | Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms | Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for heart rate | Baseline: postpartum day 1-3 | 
| Heart rate | Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for heart rate | Post-test: Change from baseline heart rate at 4 weeks postpartum | 
| Blood pressure | Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure | Baseline: postpartum day 1-3 | 
| Blood pressure | Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure | Post-test: Change from baseline heart rate at 4 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postpartum anxiety, biofeedback, diaphragmatic breathing