Postpartum AnxietyNCT05474248
Diaphragmatic Breathing Training on Postpartum Anxiety
A study testing Experimental group in people with Postpartum Anxiety, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Anxiety
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Feb 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- full-term postpartum women
- aged from 20 to 49
- STAI-S scored 40 or more at the first postpartum day
Who cannot join
- newborn with severe illness or stillbirth
- maternal suicide or self-harm
- drug use: sedatives, hypnotics or antipsychotic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of A Biofeedback-assisted Diaphragmatic Breathing Training on Postpartum Anxiety: A Randomized Controlled Trial
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
- Conditions
- Postpartum Anxiety
- Being tested
- Experimental group
- Keywords
- postpartum anxiety, biofeedback, diaphragmatic breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
Diaphragmatic Breathing Training
| Study group | Role | What they receive |
|---|---|---|
| Diaphragmatic Breathing Training | Experimental | 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. Receives: Behavioral: Experimental group |
| Control group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum anxiety
Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms
Measured: Baseline: postpartum day 1-3
Postpartum anxiety
Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms
Measured: Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum
Secondary outcomes (4)
Heart rate
Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for heart rate
Measured: Baseline: postpartum day 1-3
Heart rate
Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for heart rate
Measured: Post-test: Change from baseline heart rate at 4 weeks postpartum
Blood pressure
Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Measured: Baseline: postpartum day 1-3
Blood pressure
Assessments using A\&D sphygmomanometer (Model 767Plus, A\&D Co., LTD., Japan) for systolic blood pressure and diastolic blood pressure
Measured: Post-test: Change from baseline heart rate at 4 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start28 Feb 2021
- Primary completion12 Apr 2021
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, Taiwan
- Sponsor type
- Other government
- Collaborators
- Taichung Tzu Chi Hospital
- Responsible party
- Principal investigator, Yuh-Kae Shyu, Ministry of Science and Technology, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474248
- Sponsor's protocol ID
- TCRD-TPE-110-61
- Status last verified
- Jul 2022
- First submitted
- 22 Jul 2022
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of A Biofeedback-assisted Diaphragmatic Breathing Training on Postpartum Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05474248
- Acronym / sponsor ID
- TCRD-TPE-110-61
- Conditions
- Postpartum Anxiety
- Keywords
- postpartum anxiety, biofeedback, diaphragmatic breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology, TaiwanOther government
- Collaborators
- Taichung Tzu Chi Hospital
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diaphragmatic Breathing Training | Experimental | Behavioral: Experimental groupThe 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. |
| Control group | No intervention | –Usual care |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- full-term postpartum women
- aged from 20 to 49
- STAI-S scored 40 or more at the first postpartum day
Key exclusion criteria (3 listed)
- newborn with severe illness or stillbirth
- maternal suicide or self-harm
- drug use: sedatives, hypnotics or antipsychotic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupDiaphragmatic Breathing Training | Behavioural | Diaphragmatic Breathing Training |
Primary outcome
Postpartum anxiety
Time frame: Baseline: postpartum day 1-3
Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms
Postpartum anxiety
Time frame: Post-test: Change from baseline postpartum anxiety at 4 weeks postpartum
Assessments using the State-Trait Anxiety Inventory-State (STAI-S) for self-reported anxiety symptoms
4 secondary outcomes
Heart rate
Time frame: Baseline: postpartum day 1-3
Heart rate
Time frame: Post-test: Change from baseline heart rate at 4 weeks postpartum
Blood pressure
Time frame: Baseline: postpartum day 1-3
Blood pressure
Time frame: Post-test: Change from baseline heart rate at 4 weeks postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Postpartum Anxiety, run by Ministry of Science and Technology, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum anxiety (time frame: Baseline: postpartum day 1-3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.