Mental StressNCT04830111
The Effect of Heart Rate Variability Biofeedback Training on Health of Intrapartum Women
A study testing heart rate variability biofeedback Application (Eureka iDestressor) in people with Mental Stress, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Stress
- What is being tested?
- heart rate variability biofeedback Application (Eureka iDestressor)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2020to 12 Aug 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman
- aged 20 years or more
- able to understand and write Chinese
- singleton birth
- having a full-term and healthy newborn
Who cannot join
- suicidal ideations
- psychosis
- medical or obstetric complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Heart Rate Variability Biofeedback Training on the Physical and Mental Health of Intrapartum Women
In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women.
Read the detailed description
In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women. The following validated self-report measures were administered before and at five days after the intervention, Perceived stress scale-10, Beck Anxiety Inventory, and Edinburgh Postnatal Depression Scale.
- Conditions
- Mental Stress
- Being tested
- heart rate variability biofeedback Application (Eureka iDestressor)
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability biofeedback Application (Eureka iDestressor)Device
heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days
| Study group | Role | What they receive |
|---|---|---|
| heart rate variability biofeedback training group | Experimental | The goal of heart rate variability biofeedback is to increase heart rate variability through paced breathing exercises, which have shown to be effective in reducing stress and anxiety in general adult populations. Receives: Device: heart rate variability biofeedback Application (Eureka iDestressor) |
| Care as usual | No intervention | In this condition, all of this group take care by hospital routine and the questionnaires were completed over a period with similar intervals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress variable
The Perceived Stress Scale using 10 items to determine the self-perceived levels of unpredictability, lack of control, and burden during the last month of pregnancy. Responses are rated from 0 (never) to 4 (very often), with higher scores corresponding to higher perceived stress.
Measured: baseline on childbirth first day (before the intervention) .
Depression variable
The Edinburgh Postnatal Depression Scale was using 10 items to provide a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with item scores summed to produce a total The Edinburgh Postnatal Depression Scale was using 10 items to provides a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with higher scores corresponding to higher depression.
Measured: baseline on childbirth first day (before the intervention).
Anxiety variable
The Beck Anxiety Inventory using 21 items on the scale describes a symptom of anxiety. Responses are rated from 0 (never) to 3 (very often), with higher scores corresponding to higher perceived anxiety.
Measured: baseline on childbirth first day (before the intervention).
Secondary outcomes (3)
Stress variable
The Perceived Stress Scale using 10 items to determine the self-perceived levels of unpredictability, lack of control, and burden during the last month of pregnancy. Responses are rated from 0 (never) to 4 (very often), with higher scores corresponding to higher perceived stress.
Measured: on childbirth fifth day (after the intervention)
Depression variable
The Edinburgh Postnatal Depression Scale was using 10 items to provide a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with item scores summed to produce a total The Edinburgh Postnatal Depression Scale was using 10 items to provides a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with higher scores corresponding to higher depression.
Measured: on childbirth fifth day (after the intervention)
Anxiety variable
The Beck Anxiety Inventory using 21 items on the scale describes a symptom of anxiety. Responses are rated from 0 (never) to 3 (very often), with higher scores corresponding to higher perceived anxiety.
Measured: on childbirth fifth day (after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start12 Aug 2020
- Primary completion2 Mar 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Lin Pan, National Taipei University of Nursing and Health Sciences
- Investigators
- YUN-FEI PAO, MD, Principal investigator, Head nurse of research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830111
- Sponsor's protocol ID
- 109-E-11
- Status last verified
- Jan 2024
- First submitted
- 16 Mar 2021
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heart Rate Variability Biofeedback Training on the Physical and Mental Health of Intrapartum Women
- ClinicalTrials.gov ID
- NCT04830111
- Acronym / sponsor ID
- 109-E-11
- Conditions
- Mental Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 2 Apr 2021 (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.
In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women.
Detailed description
In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women. The following validated self-report measures were administered before and at five days after the intervention, Perceived stress scale-10, Beck Anxiety Inventory, and Edinburgh Postnatal Depression Scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heart rate variability biofeedback training group | Experimental | Device: heart rate variability biofeedback Application (Eureka iDestressor)The goal of heart rate variability biofeedback is to increase heart rate variability through paced breathing exercises, which have shown to be effective in reducing stress and anxiety in general adult populations. |
| Care as usual | No intervention | –In this condition, all of this group take care by hospital routine and the questionnaires were completed over a period with similar intervals. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- woman
- aged 20 years or more
- able to understand and write Chinese
- singleton birth
- having a full-term and healthy newborn
Key exclusion criteria (3 listed)
- suicidal ideations
- psychosis
- medical or obstetric complications
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 |
|---|---|---|
| heart rate variability biofeedback Application (Eureka iDestressor)heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days | Device | heart rate variability biofeedback training group |
Primary outcome
Stress variable
Time frame: baseline on childbirth first day (before the intervention) .
The Perceived Stress Scale using 10 items to determine the self-perceived levels of unpredictability, lack of control, and burden during the last month of pregnancy. Responses are rated from 0 (never) to 4 (very often), with higher scores corresponding to higher perceived stress.
Depression variable
Time frame: baseline on childbirth first day (before the intervention).
The Edinburgh Postnatal Depression Scale was using 10 items to provide a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with item scores summed to produce a total The Edinburgh Postnatal Depression Scale was using 10 items to provides a valuable and efficient way to identify patients at risk of perinatal depression. Each item is scored from 0 to 3, with higher scores corresponding to higher depression.
Anxiety variable
Time frame: baseline on childbirth first day (before the intervention).
The Beck Anxiety Inventory using 21 items on the scale describes a symptom of anxiety. Responses are rated from 0 (never) to 3 (very often), with higher scores corresponding to higher perceived anxiety.
3 secondary outcomes
Stress variable
Time frame: on childbirth fifth day (after the intervention)
Depression variable
Time frame: on childbirth fifth day (after the intervention)
Anxiety variable
Time frame: on childbirth fifth day (after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
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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.
YUN-FEI PAO, MD principal investigator
Head nurse of research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart rate variability biofeedback Application (Eureka iDestressor) in people with Mental Stress, run by National Taipei University of Nursing and Health Sciences 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 5 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: finished, as of the sponsor's last update on 26 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Stress variable (time frame: baseline on childbirth first day (before the intervention) .). The study lists 3 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 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.