Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students.

NCT ID: NCT06457932

Last Updated: 2024-06-13

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-02-01

Brief Summary

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

The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and a control group, in reducing stress and anxiety levels among university undergraduate students.

Detailed Description

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

Conditions

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

Stress Anxiety State

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Biofeedback training

An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.

Group Type EXPERIMENTAL

Heart rate variability biofeedback training

Intervention Type BEHAVIORAL

An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.

Meditation

An 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation.

Group Type ACTIVE_COMPARATOR

Guided meditation

Intervention Type BEHAVIORAL

An 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation.

Control

Passive, waitlist control group.

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 training

An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.

Intervention Type BEHAVIORAL

Guided meditation

An 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

1. Second- and third-year students of the Physiotherapy Degree at various universities in the province of Seville.
2. Enrolled in all courses for the academic year.
3. Enrolled in the courses for the first or second time.

Exclusion Criteria

1. Having a job in addition to academic responsibilities.
2. Having a dependent family member under their care.
3. Diagnosed with any mental health issues.
4. Diagnosed with severe metabolic, cardiovascular, or respiratory conditions, or cancer.
5. Simultaneously pursuing another degree or a dual degree program.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

University of Seville

OTHER

Sponsor Role lead

Responsible Party

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

Hermann Fricke Comellas

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Hermann Fricke-Comellas, PhD Student

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hermann Fricke-Comellas, PhD Student

Role: CONTACT

672279589 ext. +34

Other Identifiers

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

77859612N

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Biofeedback for CHAMPS
NCT04921228 COMPLETED NA
Mindfulness With Biofeedback
NCT02769403 COMPLETED NA
Stress Management Program
NCT06526585 RECRUITING NA
Stress and Sleep Study
NCT05218109 COMPLETED NA