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

NCT ID: NCT04830111

Last Updated: 2024-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-12

Study Completion Date

2022-08-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

heart rate variability biofeedback Application (Eureka iDestressor)

Intervention Type DEVICE

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

heart rate variability biofeedback Application (Eureka iDestressor)

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wan-Lin Pan

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

YUN-FEI PAO, MD

Role: PRINCIPAL_INVESTIGATOR

Head nurse of research hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wan-Lin Pan

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

109-E-11

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mental Training and Childbirth
NCT00914082 COMPLETED NA
The Effect of Podcast Training on Birth Fear in Couples
NCT06929975 ENROLLING_BY_INVITATION NA