HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
NCT07415915 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-02-20
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.
Conditions
- Stress (Psychology)
- Anxiety
- Psychological Distress
Interventions
- BEHAVIORAL
-
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
Sponsors & Collaborators
-
Egas Moniz - Cooperativa de Ensino Superior, CRL
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2026-05-01
- Completion
- 2026-08-01
Countries
- Portugal
Study Locations
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