Clinical Trial

HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition

Study acronym: HRVB-MIMD
Enrolling by Invitation
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Record status
This record was last updated February 20, 2026 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to learn if Heart Rate Variability Biofeedback (HRVB) can reduce stress and anxiety in dentistry students during the transition from pre-clinical training to clinical practice. The main questions this study aims to answer are: 1. Does HRVB training reduce perceived stress, measured with the Perceived Stress Scale (PSS-10), from baseline to post-intervention and to 2-month follow-up? 2. Does HRVB training reduce psychological distress, measured with the Kessler Psychological Distress Scale, 10-item version (K-10), from baseline to post-intervention and to 2-month follow-up? 3. Does HRVB training reduce anxiety, measured with the State-Trait Anxiety Inventory, Form Y, State subscale state anxiety (STAI Y-1), from baseline to post-intervention and to 2-month follow-up? Researchers will compare an HRVB training group to a control group (no intervention) to see if HRVB leads to greater improvements in stress, distress, and anxiety across the study time points. Participants will: * Receive study information and provide electronic informed consent. * Complete online baseline questionnaires (sociodemographic questionnaire, K-10, PSS-10, and STAI Y-1). * Be randomly assigned to one of two groups: HRVB training or control (no intervention). * If assigned to the HRVB group, complete a 5-week program with 10 sessions (twice per week; about 10 minutes per session) using an emWave2 HRVB device; participants will practice slow breathing (about 6 breaths per minute) while recalling a positive memory, with real-time feedback provided in a game format. * If assigned to the HRVB group, practice the breathing exercise daily. * If assigned to the control group, not receive HRVB sessions or daily breathing training as part of the study, and only complete the study assessments at the scheduled time points. * Complete the post-intervention assessment online after the intervention period (same questionnaires as baseline except the sociodemographic questionnaire). * Complete a follow-up assessment online about 2 months after the end of the intervention period; participants will be contacted by email to complete this follow-up questionnaire.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-02-10.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-02-18
Trial Details
NCT Number NCT07415915
Lead Sponsor Egas Moniz - Cooperativa de Ensino Superior, CRL
Conditions Stress (Psychology), Anxiety, Psychological Distress
Enrollment 50 participants
Start Date 2026-02
Primary Completion 2026-05-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-20