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

Study Overview
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Brief Summary
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In this study, the investigators examined the efficacy of heart rate variability biofeedback on physical and mental health problems in childbirth women.

Detailed Description
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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.

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

Conditions
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Mental Stress

Intervention / Treatment
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* Device: heart rate variability biofeedback Application (Eureka iDestressor)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: heart rate variability biofeedback training group<br>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. | Device: heart rate variability biofeedback Application (Eureka iDestressor)<br>* heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days<br>|
| No Intervention: Care as usual<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | baseline on childbirth first day (before the intervention). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | on childbirth fifth day (after the intervention) |