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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06457932
• Other study ID #: 77859612N
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: June 2024
• Source: University of Seville
• Contact: Hermann Fricke-Comellas, PhD Student
• Phone: 672279589
• Email: hfricke[@]us.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 54
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State
• Stress

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Heart Rate Variability (HRV)	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
Secondary	Academic Performance	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
Secondary	Adherence	Tracked using an online calendar.	Daily during the 8 week intervention