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

Mental Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04830111
• Other study ID #: 109-E-11
• Status: Completed
• Phase: N/A
• Start date: August 12, 2020
• Est. completion date: August 12, 2022

Study information

• Verified date: January 2024
• Source: National Taipei University of Nursing and Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 12, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Stress
• Stress, Psychological

Intervention

Device:
• heart rate variability biofeedback Application (Eureka iDestressor)
heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days

Locations

Country	Name	City	State
Taiwan	Wan-Lin Pan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .
Primary	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).
Primary	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	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)
Secondary	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)
Secondary	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)