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

Not Applicable

Not yet recruiting

• Conditions: Anxiety State; Stress
• Interventions: Behavioral: Guided meditation; Behavioral: Heart rate variability biofeedback training

• Registration Number: NCT06457932
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Study Start: 2024-11-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meditation	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.
Biofeedback training	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.

Primary Outcome Measures

Name	Time	Method
Anxiety State	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	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 Outcome Measures

Name	Time	Method
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	Measured using the Polar H10 band and Elite HRV app.
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	Semester grade averages compared between groups.
Adherence	Daily during the 8 week intervention	Tracked using an online calendar.