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Clinical Trials/NCT04830111
NCT04830111
Completed
Not Applicable

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

National Taipei University of Nursing and Health Sciences1 site in 1 country82 target enrollmentAugust 12, 2020
ConditionsMental Stress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mental Stress
Sponsor
National Taipei University of Nursing and Health Sciences
Enrollment
82
Locations
1
Primary Endpoint
Stress variable
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 12, 2020
End Date
August 12, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wan-Lin Pan

assistant professor

National Taipei University of Nursing and Health Sciences

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Stress variable(on childbirth fifth day (after the intervention))
  • Anxiety variable(on childbirth fifth day (after the intervention))
  • Depression variable(on childbirth fifth day (after the intervention))

Study Sites (1)

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