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
About this trial
This is an interventional treatment trial for Postpartum Anxiety focused on measuring postpartum anxiety, biofeedback, diaphragmatic breathing
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
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
NCT ID
NCT05474248
First Posted
July 22, 2022
Last Updated
July 22, 2022
Sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Taichung Tzu Chi Hospital
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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