Heart Rate Variability Biofeedback Training to Reduce Stress and Anxiety During Dentistry Students' Clinical Transition
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Perceived Stress
研究概览
简要总结
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:
- 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?
- 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?
- 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.
详细描述
This study is a randomized clinical trial designed to evaluate a brief Heart Rate Variability Biofeedback (HRVB) training program to help manage stress and anxiety during a critical stage of dentistry education: the transition from pre-clinical training to clinical practice with real patients. During this transition, students may experience increased pressure and responsibility, adapt to new clinical routines and interactions, and face concerns related to performance and making mistakes. The project focuses on whether a structured HRVB training protocol can support students' adaptation during this period and whether any potential benefits are maintained after the end of the training.
Study setting and overall design:
The study will be conducted with students from the Integrated Master's in Dentistry at Egas Moniz School of Health and Science. The design is a randomized, two-arm, parallel-group clinical trial with repeated assessments over time. After enrollment, participants will be allocated to one of two groups: (1) an experimental group that will receive the HRVB training protocol or (2) a control group that will not receive an intervention during the study period. Both groups will be assessed at three time points: baseline (pre-intervention), immediately after the intervention period (post-intervention assessment), and approximately two months after the end of the intervention (follow-up). This structure allows the study to examine changes over time within each group and to explore differences between groups across the same schedule of assessments.
Recruitment and enrollment procedures:
Recruitment will occur through direct contact with students to present the study and its objectives, as well as via announcements in university social media and flyers made available in the dental clinic. Interested students will be provided with a link to access the electronic informed consent process. Only after providing informed consent will participants be given access to the baseline assessment. Throughout recruitment, students will be provided with clear information about the study's objectives, procedures, potential risks and benefits, and the confidentiality of collected data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HRVB Training (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
干预措施: Heart Rate Variability Biofeedback (HRVB) Training (Behavioral)
Control (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).
结局指标
主要结局
Perceived Stress
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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).)