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

Primary Purpose

Mental Stress

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
heart rate variability biofeedback Application (Eureka iDestressor)
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Stress

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Wan-Lin PanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

heart rate variability biofeedback training group

Care as usual

Arm Description

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.

In this condition, all of this group take care by hospital routine and the questionnaires were completed over a period with similar intervals.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 16, 2021
Last Updated
April 1, 2021
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04830111
Brief Title
The Effect of Heart Rate Variability Biofeedback Training on Health of Intrapartum Women
Official Title
The Effect of Heart Rate Variability Biofeedback Training on the Physical and Mental Health of Intrapartum Women
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
August 12, 2021 (Anticipated)
Study Completion Date
December 12, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
heart rate variability biofeedback training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
In this condition, all of this group take care by hospital routine and the questionnaires were completed over a period with similar intervals.
Intervention Type
Device
Intervention Name(s)
heart rate variability biofeedback Application (Eureka iDestressor)
Intervention Description
heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days
Primary Outcome Measure Information:
Title
Stress variable
Description
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) .
Title
Depression variable
Description
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).
Title
Anxiety variable
Description
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 Outcome Measure Information:
Title
Stress variable
Description
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)
Title
Depression variable
Description
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
on childbirth fifth day (after the intervention)
Title
Anxiety variable
Description
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
on childbirth fifth day (after the intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
WAN-LIN PAN, PHD
Phone
0933710737
Email
wanlimp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YUN-FEI PAO, MD
Organizational Affiliation
Head nurse of research hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wan-Lin Pan
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WAN-LIN PAN, PHD
Phone
0933710737
Email
wanlimp@gmail.com

12. IPD Sharing Statement

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

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