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

NCT06457932 | Withdrawn

• 1 other identifier: 77859612N
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Anxiety State

Outcome Measures

Primary Outcomes (2)

• Stress

  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

  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 Outcomes (3)

• 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-up

• Academic Performance

  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

  Daily during the 8 week intervention

Study Arms (3)

Biofeedback training

EXPERIMENTAL

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

Meditation

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Passive, waitlist control group.

Interventions

Heart rate variability biofeedback training BEHAVIORAL

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

Biofeedback training

Guided meditation 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.

Meditation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Having a job in addition to academic responsibilities.
• Having a dependent family member under their care.
• Diagnosed with any mental health issues.
• Diagnosed with severe metabolic, cardiovascular, or respiratory conditions, or cancer.
• Simultaneously pursuing another degree or a dual degree program.

Sponsors & Collaborators

• University of Seville: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Hermann Fricke-Comellas, PhD Student

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04