HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition

Condition(s) studied

Investigational drug(s) / intervention(s)

Heart Rate Variability Biofeedback (HRVB) Training: Participants complete a 5-week HRVB protocol consisting of 10 sessions delivered twice weekly (about 10 minutes per session). During each session, participants practice slow-paced breathing (approximately 6 breaths per minute) while recalling a positive memory and receive real-time biofeedback in a game format using an HRV biofeedback device. In addition, participants are asked to practice the breathing exercise daily

Study 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.

Eligibility

Primary outcome measure(s)

• Perceived Stress — Baseline (pre-intervention), immediately post-intervention, and 2 months after the end of the intervention (follow-up)
  Perceived stress will be assessed with the Perceived Stress Scale 10-item version (Perceived Stress Scale, PSS-10). The scale total score ranges from 0 (minimum) to 40 (maximum), where higher scores indicate worse outcome
• State Anxiety — Baseline (pre-intervention), immediately post-intervention, and 2 months after the end of the intervention (follow-up).
  State anxiety will be assessed with the State Anxiety subscale of the State-Trait Anxiety Inventory, Form Y (State-Trait Anxiety Inventory, STAI Y-1). The STAI Y-1 total score ranges from 20 (minimum) to 80 (maximum), where higher scores indicate worse outcome
• Psychological Distress — Baseline (pre-intervention), immediately post-intervention, and 2 months after the end of the intervention (follow-up).
  Psychological distress will be assessed with the Kessler Psychological Distress Scale (K-10). The K-10 total score ranges from 10 (minimum) to 50 (maximum), where higher scores indicate worse outcome

Trial sites (1)

More Egas Moniz - Cooperativa de Ensino Superior, CRL trials in Portugal

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