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Diaphragmatic Breathing Training on Postpartum Anxiety

Primary Purpose

Postpartum Anxiety

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Experimental group
Sponsored by
Ministry of Science and Technology, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Anxiety focused on measuring postpartum anxiety, biofeedback, diaphragmatic breathing

Eligibility Criteria

20 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Taipei Tzu Chi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diaphragmatic Breathing Training

Control group

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for heart rate
Heart rate
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for heart rate
Blood pressure
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Blood pressure
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure

Full Information

First Posted
July 22, 2022
Last Updated
July 22, 2022
Sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Taichung Tzu Chi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05474248
Brief Title
Diaphragmatic Breathing Training on Postpartum Anxiety
Official Title
Effects of A Biofeedback-assisted Diaphragmatic Breathing Training on Postpartum Anxiety: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 28, 2021 (Actual)
Primary Completion Date
April 12, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Taichung Tzu Chi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Anxiety
Keywords
postpartum anxiety, biofeedback, diaphragmatic breathing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diaphragmatic Breathing Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Experimental group
Intervention Description
Diaphragmatic Breathing Training
Primary Outcome Measure Information:
Title
Postpartum anxiety
Description
Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms
Time Frame
Baseline: postpartum day 1-3
Title
Postpartum anxiety
Description
Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms
Time Frame
Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum
Secondary Outcome Measure Information:
Title
Heart rate
Description
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for heart rate
Time Frame
Baseline: postpartum day 1-3
Title
Heart rate
Description
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for heart rate
Time Frame
Post-test: Change from baseline heart rate at 4 weeks postpartum
Title
Blood pressure
Description
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Time Frame
Baseline: postpartum day 1-3
Title
Blood pressure
Description
Assessments using A&D sphygmomanometer (Model 767Plus, A&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Time Frame
Post-test: Change from baseline heart rate at 4 weeks postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Taipei Tzu Chi Hospital
City
Taipei
State/Province
Xindian Dist
ZIP/Postal Code
231405
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Diaphragmatic Breathing Training on Postpartum Anxiety

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