Diaphragmatic Breathing Training on Postpartum Anxiety

Postpartum Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05474248
• Other study ID #: TCRD-TPE-110-61
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 28, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2022
• Source: Ministry of Science and Technology, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Ditto

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 128
• Est. completion date: December 31, 2022
• Est. primary completion date: April 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Postpartum Anxiety
• Respiratory Aspiration

Intervention

Behavioral:
• Experimental group
Diaphragmatic Breathing Training

Locations

Country	Name	City	State
Taiwan	Taipei Tzu Chi Hospital	Taipei	Xindian Dist

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Science and Technology, Taiwan	Taichung Tzu Chi Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum anxiety	Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms	Baseline: postpartum day 1-3
Primary	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	Heart rate	Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for heart rate	Baseline: postpartum day 1-3
Secondary	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
Secondary	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
Secondary	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