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Clinical Trials/NCT06457932
NCT06457932
Not yet recruiting
Not Applicable

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

University of Seville0 sites54 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
University of Seville
Enrollment
54
Primary Endpoint
Anxiety State
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
February 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hermann Fricke Comellas

PhD Student

University of Seville

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • 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)

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