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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06457932
Enrollment
0
Registered
2024-06-13
Start date
2026-11-01
Completion date
2027-02-01
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Stress

Brief summary

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.

Interventions

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

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.

Sponsors

University of Seville
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
StressT0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-upMeasured using the Percieved Stress Scale (PSS).
Anxiety StateT0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-upMeasured using the State-Trait Anxiety Inventory (STAI).

Secondary

MeasureTime frameDescription
Heart Rate Variability (HRV)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-upMeasured using the Polar H10 band and Elite HRV app.
Academic PerformanceT0: Before the intervention; T1: At one month, before the exam period; T2: At two months, after the semester ends; T3: At three-month follow-upSemester grade averages compared between groups.
AdherenceDaily during the 8 week interventionTracked using an online calendar.

Contacts

PRINCIPAL_INVESTIGATORHermann Fricke-Comellas, PhD Student

University of Seville

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 5, 2026