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

April 27, 2026 updated by: Hermann Fricke Comellas, University of Seville

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biofeedback training
An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.
Behavioral: 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.
Active Comparator: 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.
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.
No Intervention: Control
Passive, waitlist control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Measured using the Percieved Stress Scale (PSS).
T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Anxiety State
Time Frame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Measured using the State-Trait Anxiety Inventory (STAI).
T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability (HRV)
Time Frame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Measured using the Polar H10 band and Elite HRV app.
T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Academic Performance
Time Frame: T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Semester grade averages compared between groups.
T0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-up
Adherence
Time Frame: Daily during the 8 week intervention
Tracked using an online calendar.
Daily during the 8 week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Investigators

  • Principal Investigator: Hermann Fricke-Comellas, PhD Student, University of Seville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 7, 2024

First Submitted That Met QC Criteria

June 7, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77859612N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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