NCT04830111 - The Effect of Heart Rate Variability Biofeedback Training on Health of Intrapartum Women | Crick

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

82

Conditions

Mental Stress

Interventions

heart rate variability biofeedback Application (Eureka iDestressor)DEVICE

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wan-Lin Pan

Taipei, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: baseline on childbirth first day (before the intervention).

Secondary Outcomes

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.

Time frame: 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.