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Status unknownNCT05474248Updated Jul 26, 2022

Diaphragmatic Breathing Training on Postpartum Anxiety

An interventional study of Experimental group in Postpartum Anxiety, sponsored by Ministry of Science and Technology, Taiwan. Status unknown at 1 site in Taiwan. Open to female participants aged 20 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-26.

Sponsored by Ministry of Science and Technology, Taiwan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Enrolling by invitation — may be out of date.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Feb 2021, registered Jul 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
20 Years to 49 Years
Sex
Female
01

Study 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.

Read the detailed description

Ditto

02

Conditions studied

  • Postpartum Anxiety

Keywords

  • postpartum anxiety
  • biofeedback
  • diaphragmatic breathing
03

In context

Lead sponsor

Ministry of Science and Technology, Taiwan is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • full-term postpartum women
  • aged from 20 to 49
  • STAI-S scored 40 or more at the first postpartum day

Exclusion criteria

Exclusion Criteria:

  • newborn with severe illness or stillbirth
  • maternal suicide or self-harm
  • drug use: sedatives, hypnotics or antipsychotic drugs
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    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.

    Behavioral: Experimental group

  • No intervention
    Control group

    Usual care

Interventions

  • BehavioralExperimental group

    Diaphragmatic Breathing Training

06

What researchers measure

Primary outcomes

  1. Postpartum anxiety

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

    Time frame: Baseline: postpartum day 1-3

  2. Postpartum anxiety

    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 outcomes

  1. Heart rate

    Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for heart rate

    Time frame: Baseline: postpartum day 1-3

  2. Heart rate

    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

  3. Blood pressure

    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

  4. Blood pressure

    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

07

Study locations

1 site
  • Taipei Tzu Chi Hospital
    Taipei, Xindian Dist 231405, Taiwan
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2021 to primary completion in Apr 2021, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2022
First posted
Jul 26, 2022
StartActual
Feb 28, 2021
Primary completionActual
Apr 12, 2021
CompletionEst.
Dec 31, 2022
Last update
Jul 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05474248
Lead sponsor
Ministry of Science and Technology, Taiwan
Collaborators
Taichung Tzu Chi Hospital
Responsible party
Yuh-Kae Shyu (Assistant Professor, Ministry of Science and Technology, Taiwan) — Principal investigator
First posted
Jul 26, 2022
Start date
Feb 28, 2021
Primary completion
Apr 12, 2021
Completion
Dec 31, 2022 (estimated)
Last update
Jul 26, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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