Diaphragmatic Breathing Training on Postpartum Anxiety

NCT ID: NCT05474248

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2022-12-31

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

Conditions

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Postpartum Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Diaphragmatic Breathing Training

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.

Group Type EXPERIMENTAL

Experimental group

Intervention Type BEHAVIORAL

Diaphragmatic Breathing Training

Control group

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Experimental group

Diaphragmatic Breathing Training

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taichung Tzu Chi Hospital

OTHER

Sponsor Role collaborator

Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yuh-Kae Shyu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei Tzu Chi Hospital

Taipei, Xindian Dist, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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TCRD-TPE-110-61

Identifier Type: -

Identifier Source: org_study_id

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