Meta description regulatory update notes a not yet recruiting trial evaluating heart rate variability biofeedback to ease stress and anxiety in dental students during clinical transition. Publication date context February 19, 2026. A regulatory style notice highlights a not yet recruiting trial that evaluates heart rate variability biofeedback as a behavioral intervention to address stress and anxiety in dental students during clinical transition. Sponsor is Egas Moniz Cooperativa de Ensino Superior CRL. The intervention is described as Behavioral HRVB Training. The trial is not yet recruiting and is registered on ClinicalTrials.gov with the identifier NCT07415915. For more information refer to the official ClinicalTrials.gov page at ClinicalTrials.gov NCT07415915.
What is the intervention and who is involved?
The record lists an intervention described as Behavioral HRVB Training. The target population comprises dentistry students undergoing clinical transition and experiencing stress, anxiety and psychological distress as described by the conditions list on the record. The sponsor is Egas Moniz Cooperativa de Ensino Superior CRL. The trial is not yet recruiting and is registered on ClinicalTrials.gov with the identifier NCT07415915.
For more information refer to the official ClinicalTrials.gov page at ClinicalTrials.gov NCT07415915.
What is HRV biofeedback training?
Heart rate variability biofeedback training is described as a behavioral intervention intended to support stress and anxiety management. The entry does not include device claims or direct disease treatment statements in this entry.
Who is sponsoring?
The sponsor listed is Egas Moniz Cooperativa de Ensino Superior CRL, with the registration appearing on the ClinicalTrials.gov entry.
What are the regulatory considerations for a HRVB trial in education?
The record frames the approach as a behavioral intervention rather than a device intended to treat a disease. This distinction influences how the intended use is described and what safety claims would be appropriate in the future. The entry does not provide results and states not yet recruiting, which affects regulatory oversight at this stage.
What is the intended use as described in the record?
The entry frames the activity as addressing stress and anxiety through a behavioral approach and does not specify a therapeutic indication or disease modification claim.
Are safety and potential outcomes described?
The entry provides no trial results in this posting. No outcomes are reported. Safety monitoring plans or protocols are not included in the registry entry and would typically be expected if the trial progresses to later phases or reports results.
What outcomes could be tracked in such trials?
In similar contexts, outcomes would include measures of stress and anxiety, but the current record does not list these as defined endpoints.
What is the recruitment status and timeline?
The ClinicalTrials.gov entry indicates Not yet recruiting. As a result signal, implementation timelines and results release would depend on protocol development and regulatory review if the study proceeds.
FAQ
- 1. What is HRVB training? The entry describes HRVB training as a behavioral intervention aimed at reducing stress and anxiety among dentistry students during clinical transition.
- 2. Who is sponsoring? The sponsor is Egas Moniz Cooperativa de Ensino Superior CRL as listed in the registry.
- 3. Where can I find more information? See the ClinicalTrials.gov page for NCT07415915 at the link below.
Conclusion and takeaways for professionals
HRVB based trial in dental education shows how regulators and researchers approach non drug strategies for mental health in an educational setting. For regulatory teams the key steps are to monitor the registry for updates, assess any future device related claims and prepare the necessary safety and performance documentation if the study progresses.
Disclaimer
This information is intended for professionals and does not constitute legal advice. It reflects the content of the source text and is not a formal regulatory interpretation.
https://clinicaltrials.gov/study/NCT07415915?term=medical+device