NCT06926257

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 13, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 7, 2025

Last Update Submit

April 11, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Attention and reaction time

    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

    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

    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

    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

    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.

Study Arms (3)

Control group (A) - no intervention

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 group (B) - breathing training using VR

EXPERIMENTAL

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

Experimental group (C) - breathing training using relaxation music

EXPERIMENTAL

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

Interventions

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.

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 group (B) - breathing training using VR

Eligibility Criteria

Age23 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Poznań University of Physical Education

Poznan, 61871, Poland

Location

MeSH Terms

Conditions

EmergenciesSleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChronobiology DisordersNervous System DiseasesDyssomniasSleep Wake DisordersOccupational DiseasesMental Disorders

Central Study Contacts

Łucja Rząsa, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 13, 2025

Study Start

April 7, 2025

Primary Completion

October 30, 2025

Study Completion

December 30, 2025

Last Updated

April 13, 2025

Record last verified: 2025-04

Locations