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Completed

NCT Number: NCT04830111

The Effect of Heart Rate Variability Biofeedback Training on 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.

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Key information

Conditions

Mental Stress Behavior Behavioral Symptoms Stress, Psychological

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wan-Lin Pan

Taipei, 114, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

heart rate variability biofeedback Application (Eureka iDestressor)

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Stress variable

    Time frame: on 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.

  2. Depression variable

    Time frame: on 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.

  3. Anxiety variable

    Time frame: on 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.

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 2, 2021
Registry last updated
Jan 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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