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

April 11, 2025 updated by: Poznan University of Physical Education

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Poznań, Poland, 61871
        • Poznan University of Physical Education
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

The study will be conducted in a group of paramedics and nurses of both sexes, aged 23-45. It is expected that 60 people will be examined. The study will include hospital emergency department employees, working shifts, with a minimum of two years of work experience. Those who receive a doctor's consent to participate in the study and give informed consent will be admitted to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.

  • A total of 8 sessions over 4 weeks.
  • 2 trainings per week (after the end of night duty).
  • Each session lasts 20 minutes.
Other: Experimental group (C) - breathing training using relaxation music
  • Diaphragmatic breathing - the conscious engagement of the diaphragm in the inhalation process.
  • Controlled exhalation lengthening - a technique to lengthen the exhalation phase.
  • Rhythmic breathing - synchronizing breathing with a set pace to improve breath control.

Structure of each session:

  1. introductory phase (3 minutes)

    • Participants assume a comfortable sitting or lying position.
    • Brief instruction on proper breathing.

  2. training phase (15 minutes).

    • Participants listen to relaxation music while focusing on the breathing techniques they learned before the session.

    • Breathing techniques used include those learned during the training: diaphragmatic breathing, controlled expiration lengthening, rhythmic breathing.

      3 Relaxation phase (2 minutes)

    • Gradual exit from the training session, focusing attention on the sensations of the body and mind.
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.

  • A total of 8 sessions over 4 weeks.
  • 2 trainings per week (after the end of night duty).
  • Each session lasts 20 minutes.
Other: Experimental group (B) - breathing training using VR

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:

  1. diaphragmatic breathing - the participant takes slow, controlled breaths, inhaling into the diaphragm and exhaling at a set pace. The game visualizes breathing through animations of water waves and background color changes.
  2. rhythmic breathing - the participant sts his breathing rhythm to the changing visual and audio stimuli, allowing for synchronous breathing control.
  3. Controlled exhalation lengthening - the participant learns the technique of slow exhalation of air to improve relaxation and reduce tension.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Attention and reaction time
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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.
At the beginning of the study and after 4 weeks of breathing exercises.
Postural stability
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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.
At the beginning of the study and after 4 weeks of breathing exercises.
Sleep quality
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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).
At the beginning of the study and after 4 weeks of breathing exercises.
Stress level and mood
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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.
At the beginning of the study and after 4 weeks of breathing exercises.
Fine motor skills precision
Time Frame: At the beginning of the study and after 4 weeks of breathing exercises.
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).
At the beginning of the study and after 4 weeks of breathing exercises.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poznan University of Physical Education

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 165/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision on data sharing has not been finalized. The availability of individual participant data (IPD) and supporting documents will be assessed after the study is completed. If data sharing is approved, details regarding access, format, and conditions will be provided in future updates.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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