StressNCT06457932
Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress Levels in University Undergraduate Students
A study testing Heart rate variability biofeedback training and Guided meditation in people with Stress and Anxiety State, run by University of Seville.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety State
- What is being tested?
- Heart rate variability biofeedback training and Guided meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress and Anxiety Levels in University Undergraduate Students
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
- Being tested
- Heart rate variability biofeedback training, Guided meditation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart rate variability biofeedback trainingBehavioural
An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application.
Guided meditationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback training | Experimental | An 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application. Receives: 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. Receives: Behavioral: Guided meditation |
| Control | No intervention | Passive, waitlist control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress
Measured using the Percieved Stress Scale (PSS).
Measured: 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).
Measured: 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)
Measured using the Polar H10 band and Elite HRV app.
Measured: 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
Semester grade averages compared between groups.
Measured: 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
Tracked using an online calendar.
Measured: Daily during the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Nov 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Why it stopped: Not enough students enrolled in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermann Fricke Comellas, University of Seville
- Investigators
- Hermann Fricke-Comellas, PhD Student, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457932
- Sponsor's protocol ID
- 77859612N
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2024
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Heart Rate Variability Biofeedback Training Versus a Meditation Program in Reducing Stress and Anxiety Levels in University Undergraduate Students
- ClinicalTrials.gov ID
- NCT06457932
- Acronym / sponsor ID
- 77859612N
- Conditions
- Stress, Anxiety State
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough students enrolled in the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofeedback training | Experimental | Behavioral: Heart rate variability biofeedback trainingAn 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application. |
| Meditation | Active comparator | Behavioral: Guided meditationAn 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation. |
| Control | No intervention | –Passive, waitlist control group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart rate variability biofeedback trainingAn 8-week intervention based on daily 10-minute HRV biofeedback training at rest using the Pulse HRV smartphone application. | Behavioural | Biofeedback training |
| Guided meditationAn 8-week intervention based on daily 10-minute guided meditation sessions led by an instructor with over 20 years of experience in teaching meditation. | Behavioural | Meditation |
Primary outcome
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).
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).
3 secondary outcomes
Heart Rate Variability (HRV)
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
Academic Performance
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
Adherence
Time frame: Daily during the 8 week intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermann Fricke-Comellas, PhD Student principal investigator
University of Seville
Questions about this trial
What is this clinical trial studying?
A study testing Heart rate variability biofeedback training and Guided meditation in people with Stress and Anxiety State, run by University of Seville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.