- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06926257
Effects of VR-based Respiratory Training on Motor Reaction Time and Correctness, Stress Levels, Attention, Motor Skills, Postural Stability and Sleep Quality in Shift Healthcare Workers
This study investigates the effects of virtual reality (VR)-based respiratory training on various physiological and cognitive functions in shift-working healthcare professionals, including paramedics and nurses. The research will evaluate how VR-guided breathing exercises influence: stress levels, motor reaction time and accuracy, attention and cognitive performance, motor skills and postural stability, sleep quality
Participants will be divided into three groups:
VR-based respiratory training group - performing guided breathing exercises in a VR environment.
Music-based relaxation group - listening to relaxing music without structured breathing instructions.
Control group - no intervention.
The findings will help determine whether VR-based respiratory training is an effective method for improving stress resilience, cognitive function, and physical performance in shift-working healthcare professionals.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Łucja Rząsa, MSc
- Phone Number: +48790885122
- Email: rzasa@awf.poznan.pl
Study Locations
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Poznań, Poland, 61871
- Poznan University of Physical Education
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Contact:
- Marzena Szerment
- Phone Number: 61 835 50 00
- Email: szerment@awf.poznan.pl
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control group (A) - no intervention
All participants will first be measured before and after their first night's duty to determine the baseline level of the accepted variables.
Subsequently, the subjects will be informed not to use any additional forms of relaxation, and after four weeks, the study participants will undergo a final measurement.
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Experimental: Experimental group (B) - breathing training using VR
Breathing training in the experimental group will be carried out under controlled conditions, in a quiet room, using VR goggles and the Flowborne VR - Biofeedback Breathing Meditation application. The goal of the program is to learn conscious breathing and reduce stress levels through an immersive virtual reality environment.
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Structure of each session:
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Experimental: Experimental group (C) - breathing training using relaxation music
Breathing training will be based on traditional relaxation methods using relaxation music. This program will be conducted under controlled conditions in a quiet room, without the use of VR technology.
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The Flowborne VR - Biofeedback Breathing Meditation game is an interactive training environment that guides the participant through a series of breathing exercises. The app adjusts the difficulty level and pace of the workout in real time based on the participant's physiological parameters, such as breathing rhythm. Types of exercises in the game:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Attention and reaction time
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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he MOXO Test is a computer-based diagnostic tool used to assess attention and impulse control.
Participants respond to various visual and auditory stimuli appearing on the screen, where they must quickly and accurately recognize those that require a response while ignoring others designed to distract them.
The test lasts approximately 15-18 minutes and evaluates four key indicators: reaction time, impulsivity, hyperactivity, and inattention.
This allows for a detailed analysis of the participant's cognitive abilities and identification of potential attention deficits.
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At the beginning of the study and after 4 weeks of breathing exercises.
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Postural stability
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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The assessment will be conducted using a standard, low, stable posturographic platform.
The first measurement will be taken in an upright posture with an attempt to lean the body as far forward and backward as possible while maintaining stability.
The second measurement involves standing on one leg.
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At the beginning of the study and after 4 weeks of breathing exercises.
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Sleep quality
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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The impact of the intervention on participants' sleep quality, particularly in the context of shift work, will be assessed using the Polish version of the Pittsburgh Sleep Quality Index (PSQI).
This measurement will be conducted twice: before the first night shift and before the last night shift (Mollayeva et al., 2016).
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At the beginning of the study and after 4 weeks of breathing exercises.
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Stress level and mood
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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Stress levels will be assessed using the PSS-10 Perceived Stress Scale (Cohen S., Kamarck T., Mermelstein R., 1983), adapted to Polish (Juczyński Z., Ogińska-Bulik N., 2009), which evaluates the intensity of stress related to one's life situation over the past month (Matuszczak-Świgoń et al., 2023).
Additionally, the PANAS (Positive and Negative Affect Schedule) questionnaire will be used to measure participants' positive and negative affect, assessing the intensity of their emotions before and after the intervention (Piotr Brzozowski, 2019).
Subjective mood and the intensity of its changes will also be evaluated using a 0-10 scale before each measurement.
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At the beginning of the study and after 4 weeks of breathing exercises.
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Fine motor skills precision
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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Fine motor skills precision will be assessed using the WorkAbility Rate of Manipulation Test (WRMT).
This test is a tool for evaluating manual skills in a work-related context.
It consists of a task requiring participants to transfer discs from one place to another, measuring precision, speed, and dexterity.
WRMT is used in the assessment of manual task performance abilities in various industries, including vocational rehabilitation and work capacity evaluation (Wang et al., 2018).
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At the beginning of the study and after 4 weeks of breathing exercises.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 165/25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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