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

• Sponsor: National Taipei University of Nursing and Health Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04830111
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 16
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Stress	Device: heart rate variability biofeedback Application (Eureka iDestressor)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: The Effect of Heart Rate Variability Biofeedback Training on the Physical and Mental Health of Intrapartum Women
• Actual Study Start Date: Aug 12, 2020
• Anticipated Primary Completion Date: Aug 12, 2021
• Anticipated Study Completion Date: Dec 12, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Stress variable [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 [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 [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 Outcome Measures

1. Stress variable [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wan-Lin Pan	Taipei		Taiwan	114

Sponsors and Collaborators

• National Taipei University of Nursing and Health Sciences

Investigators

• Principal Investigator: YUN-FEI PAO, MD, Head nurse of research hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wan-Lin Pan, assistant professor, National Taipei University of Nursing and Health Sciences
• ClinicalTrials.gov Identifier: NCT04830111
• Other Study ID Numbers: 109-E-11
• First Posted: Apr 2, 2021
• Last Update Posted: Apr 2, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stress, Psychological

Study Results

No Results Posted as of Apr 2, 2021