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The Effect of Heart Rate Variability Biofeedback Training on Health of Intrapartum Women

The Effect of Heart Rate Variability Biofeedback Training on the Physical and Mental Health of Intrapartum Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04830111
Enrollment
82
Registered
2021-04-02
Start date
2020-08-12
Completion date
2022-08-12
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Stress

Brief summary

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.

Interventions

DEVICEheart rate variability biofeedback Application (Eureka iDestressor)

heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days

Sponsors

National Taipei University of Nursing and Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* woman * aged 20 years or more * able to understand and write Chinese * singleton birth * having a full-term and healthy newborn

Exclusion criteria

* suicidal ideations * psychosis * medical or obstetric complications

Design outcomes

Primary

MeasureTime frameDescription
Stress variablebaseline 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 variablebaseline 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 variablebaseline 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.

Secondary

MeasureTime frameDescription
Stress variableon childbirth fifth day (after 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 variableon childbirth fifth day (after 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 variableon childbirth fifth day (after 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026