HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition

NCT07415915 | Enrolling By Invitation

• 1 other identifier: CIIEM-ICP-51
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Heart Rate Variability Biofeedback; HRV Biofeedback; Biofeedback Training; Cardiac Coherence; Paced Breathing; Stress; Perceived Stress; Anxiety; State Anxiety; Psychological Distress; Dental Students; Dentistry Students

Outcome Measures

Primary Outcomes (3)

• Perceived Stress

  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

  Baseline (pre-intervention), immediately post-intervention, and 2 months after the end of the intervention (follow-up)

• State Anxiety

  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

  Baseline (pre-intervention), immediately post-intervention, and 2 months after the end of the intervention (follow-up).

• Psychological Distress

  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

  Baseline (pre-intervention), immediately post-intervention, and 2 months after the end of the intervention (follow-up).

Secondary Outcomes (3)

• HRV (RMSSD, ms) During HRV Biofeedback Sessions (Kubios HRV)

  Each intervention session (Sessions 1-10; 10 minutes per session).

• Mean Heart Rate (bpm) During HRV Biofeedback Sessions (Kubios HRV)

  Each intervention session (Sessions 1-10; 10 minutes per session).

• Sympathetic Activity (SNS Index) During HRV Biofeedback Sessions (Kubios HRV)

  Each intervention session (Sessions 1-10; 10 minutes per session).

Study Arms (2)

HRVB Training (Experimental)

EXPERIMENTAL

Participants complete a 5-week HRV biofeedback (HRVB) program consisting of 10 sessions (twice weekly; \~10 minutes/session). They are instructed to breathe slowly (\~6 breaths/min) while recalling a positive memory and receive real-time feedback in a game format using the emWave2 device. In addition, participants practice the breathing exercise daily

Behavioral: Heart Rate Variability Biofeedback (HRVB) Training

Control (No Intervention)

NO INTERVENTION

Participants assigned to the control arm do not receive HRV biofeedback sessions and are not asked to perform daily breathing training as part of the study. They complete the same online questionnaire assessments as the experimental arm at baseline (pre-intervention), immediately after the intervention period (post-intervention), and at approximately 2-month follow-up (completed after email contact).

Interventions

Heart Rate Variability Biofeedback (HRVB) Training BEHAVIORAL

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

Also known as: HRV Biofeedback Training, Cardiac Coherence Biofeedback Training

HRVB Training (Experimental)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the Integrated Master's in Dentistry at Egas Moniz School of Health and Science.
• Attending the 4th year of the program for the first time (transition from pre-clinical to clinical training).
• Able to provide informed consent autonomously.

You may not qualify if:

• Initiation or change in the last 6 months of psychopharmacological medication or psychotherapy (including psychological support/supportive psychotherapy)
• Diagnosed psychiatric disorder.
• Regular use (more than twice per week) of psychotropic substances.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Setúbal District, 2829 - 511, Portugal

Location

Related Publications (16)

• Chaló, P., & Pereira, A. (2020). Biofeedback e bem-estar na universidade: 6 anos de estudos na intervenção sobre stresse e ansiedade elevada. Actas Do 13o Congresso Nacional de Psicologia Da Saúde, 163-172.

  BACKGROUND

• Chaló, P., Batista, P., & Pereira, A. (2017). Biofeedback training on university student's anxiety management: A systematic review. Biomedical Research and Clinical Practice, 2(1), 1-6. https://doi.org/10.15761/BRCP.1000129

  BACKGROUND

• Chalo P, Pereira A, Batista P, Sancho L. Brief Biofeedback Intervention on Anxious Freshman University Students. Appl Psychophysiol Biofeedback. 2017 Sep;42(3):163-168. doi: 10.1007/s10484-017-9361-5.

  PMID: 28527121 BACKGROUND

• Lehrer PM, Gevirtz R. Heart rate variability biofeedback: how and why does it work? Front Psychol. 2014 Jul 21;5:756. doi: 10.3389/fpsyg.2014.00756. eCollection 2014.

  PMID: 25101026 BACKGROUND

• Gullett N, Zajkowska Z, Walsh A, Harper R, Mondelli V. Heart rate variability (HRV) as a way to understand associations between the autonomic nervous system (ANS) and affective states: A critical review of the literature. Int J Psychophysiol. 2023 Oct;192:35-42. doi: 10.1016/j.ijpsycho.2023.08.001. Epub 2023 Aug 3.

  PMID: 37543289 BACKGROUND

• Gonçalves, M. F. P., Rebelo, P. M., & Macedo de Oliveira, M. V. (2023). Estresse, Ansiedade E Depressão Em Acadêmicos De Odontologia De Uma Instituição De Montes Claros. Revista Unimontes Científica, 25(2), 1-24. https://doi.org/10.46551/ruc.v25n2a4

  BACKGROUND

• van der Zwan JE, de Vente W, Huizink AC, Bogels SM, de Bruin EI. Physical activity, mindfulness meditation, or heart rate variability biofeedback for stress reduction: a randomized controlled trial. Appl Psychophysiol Biofeedback. 2015 Dec;40(4):257-68. doi: 10.1007/s10484-015-9293-x.

  PMID: 26111942 BACKGROUND

• Pham T, Lau ZJ, Chen SHA, Makowski D. Heart Rate Variability in Psychology: A Review of HRV Indices and an Analysis Tutorial. Sensors (Basel). 2021 Jun 9;21(12):3998. doi: 10.3390/s21123998.

  PMID: 34207927 BACKGROUND

• Gerreth K, Chlapowska J, Lewicka-Panczak K, Sniatala R, Ekkert M, Borysewicz-Lewicka M. Self-Evaluation of Anxiety in Dental Students. Biomed Res Int. 2019 Dec 28;2019:6436750. doi: 10.1155/2019/6436750. eCollection 2019.

  PMID: 31950047 BACKGROUND

• de Souza Ferreira F, Barros I, da Costa Neves T, Pazos JM, Garcia PPNS. Stress amongst dental students in the transition from preclinical training to clinical training: A qualitative study. Eur J Dent Educ. 2023 Aug;27(3):568-574. doi: 10.1111/eje.12842. Epub 2022 Aug 9.

  PMID: 35945161 BACKGROUND

• Ratanasiripong P, Ratanasiripong N, Kathalae D. Biofeedback Intervention for Stress and Anxiety among Nursing Students: A Randomized Controlled Trial. ISRN Nurs. 2012;2012:827972. doi: 10.5402/2012/827972. Epub 2012 Jun 28.

  PMID: 22811932 BACKGROUND

• Blase K, Vermetten E, Lehrer P, Gevirtz R. Neurophysiological Approach by Self-Control of Your Stress-Related Autonomic Nervous System with Depression, Stress and Anxiety Patients. Int J Environ Res Public Health. 2021 Mar 24;18(7):3329. doi: 10.3390/ijerph18073329.

  PMID: 33804817 BACKGROUND

• Brinkmann AE, Press SA, Helmert E, Hautzinger M, Khazan I, Vagedes J. Comparing Effectiveness of HRV-Biofeedback and Mindfulness for Workplace Stress Reduction: A Randomized Controlled Trial. Appl Psychophysiol Biofeedback. 2020 Dec;45(4):307-322. doi: 10.1007/s10484-020-09477-w.

  PMID: 32556709 BACKGROUND

• Basudan S, Binanzan N, Alhassan A. Depression, anxiety and stress in dental students. Int J Med Educ. 2017 May 24;8:179-186. doi: 10.5116/ijme.5910.b961.

  PMID: 28553831 BACKGROUND

• Alzahem AM, Van der Molen HT, Alaujan AH, De Boer BJ. Stress management in dental students: a systematic review. Adv Med Educ Pract. 2014 May 28;5:167-76. doi: 10.2147/AMEP.S46211. eCollection 2014.

  PMID: 24904226 BACKGROUND

• Alamoush RA, Al-Sawaeir S, Baker DA, Aljamani SA, Alomoush SA, Al-Omiri MK. Stress experienced by dental students performing clinical training in different dental disciplines: a cross-sectional study. J Occup Health. 2024 Jan 4;66(1):uiae006. doi: 10.1093/joccuh/uiae006.

  PMID: 38348494 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel-group design with two arms: an experimental HRVB training group and a control group with no intervention during the study period; both groups complete the same online assessments at baseline (pre-intervention), immediately post-intervention, and at \~2-month follow-up.

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)