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

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

Study Overview

• Status: Completed
• Conditions: Mental Stress
• Intervention / Treatment: Device: heart rate variability biofeedback Application (Eureka iDestressor)

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.

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Wan-Lin Pan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: heart rate variability biofeedback training group; 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); heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days
No Intervention: Care as usual; 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?

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)

Collaborators and Investigators

• Sponsor: National Taipei University of Nursing and Health Sciences
• Investigators: Principal Investigator: YUN-FEI PAO, MD, Head nurse of research hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): March 2, 2022
• Study Completion (Actual): August 12, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: 109-E-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No