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

NCT04830111 | Completed

• 1 other identifier: 109-E-11
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mental Stress

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Stress variable

  on childbirth fifth day (after the intervention)

• Depression variable

  on childbirth fifth day (after the intervention)

• Anxiety variable

  on childbirth fifth day (after the intervention)

Study Arms (2)

heart rate variability biofeedback training group

EXPERIMENTAL

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)

Care as usual

NO INTERVENTION

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

Interventions

heart rate variability biofeedback Application (Eureka iDestressor) DEVICE

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

heart rate variability biofeedback training group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• woman
• aged 20 years or more
• able to understand and write Chinese
• singleton birth
• having a full-term and healthy newborn

You may not qualify if:

• suicidal ideations
• psychosis
• medical or obstetric complications

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead

Study Sites (1)

Wan-Lin Pan

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• YUN-FEI PAO, MD

  Head nurse of research hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: April 2, 2021
• Study Start: August 12, 2020
• Primary Completion: March 2, 2022
• Study Completion: August 12, 2022
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

TW (1)