Blunt Chest TraumaVIREX PURENCT05194176
The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma
A study testing Virtual Reality in people with Blunt Chest Trauma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Blunt chest trauma comprises over 10% of all trauma patients presenting to emergency departments worldwide and is the most frequent injury in polytrauma patients. It is associated with high risk (>10%) of pulmonary complications such as pneumonia. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Blunt Chest Trauma
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Mar 2022to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted to the trauma ward with sustained blunt chest trauma
- Age≥16
- Patient is willing and able to comply with the study protocol
Who cannot join
- Neurotrauma with GCS ≤13
- History of dementia, seizures, epilepsy
- Severe hearing/visual impairment not corrected
- Head wounds or damaged skin with which comfortable and hygienic use is not possible.
- Stay at intensive care unit (ICU) during current hospital admission.
- Erect position in bed not possible/allowed.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center
Nijmegen, Gelderland, 6525 GA
About this study
Blunt chest trauma comprises over 10% of all trauma patients presenting to emergency departments worldwide and is the most frequent injury in polytrauma patients. It is associated with high risk (>10%) of pulmonary complications such as pneumonia. Pillars of treatment are adequate pain relief, respiratory function exercises and rapid mobilisation through physiotherapy. Inadequate pain control can result in restricted ventilatory function and in reduced mobility, both resulting in a higher risk of particularly pulmonary complications. Virtual Reality (VR) might be an easy to use, individualized, and harmless technique that can facilitate pulmonary recovery and aid in the prevention of complications through reducing pain and promoting exercising. The investigators hypothesize that VR improves respiratory function and mobilisation in the post-acute phase of blunt chest trauma by distracting patients from pain and stress, and by stimulating pulmonary and physical exercise.
- Conditions
- Blunt Chest Trauma
- Being tested
- Virtual Reality
- Keywords
- Virtual Reality, Trauma, Pulmonary Recovery
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
For all VR exercises a head mounted display (HMD), the PICO G2 4K (Barcelona, Spain) will be used. Together with SyncVRMedical (Utrecht, Netherlands) a VR dashboard has been created from which patients can chose the different exercises.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will receive usual care. Patients will be instructed to perform respiratory exercises 8 times daily for 10 minutes and to extend these exercises 2 times daily with (sitting) physical exercises for an additional 10 minutes. Respiratory exercises include using incentive spirometry and exercises for deep breathing, huffing and coughing. Patients receive a leaflet with the exercises described and the exercises will be performed once daily under supervision of a physiotherapist. The other sessions will be unsupervised. |
| Virtual Reality | Experimental | The intervention group will be instructed to perform the respiratory exercises using the VR-intervention 8 times daily for 10 minutes and to extend these exercises 2 times daily with (sitting) physical exercises for an additional 10 minutes. The respiratory exercises in VR are comparable to the exercises in usual care but performed in a virtual environment and without incentive spirometry. The physical exercises consist of several games through which patients are challenged to reach out to objects while engaging their core. Patients are allowed to continue these exercises or play some relaxation games for up to 30 minutes per session in total. The exercises will be performed once daily under supervision of a physiotherapist. The other sessions will be unsupervised. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiration volume, mean change from baseline
Mean change from baseline in inspiration volume in ml, measured with an incentive spirometer (Voldyne)
Measured: From baseline to end of treatment at day 5.
Inspiration volume, repeated measures over 5 days
change in mean daily inspiration volume in mL, measured with an incentive spirometer (Voldyne)
Measured: Twice daily from enrollment to day 5 of treatment
Secondary outcomes (8)
Time spent sitting or standing, mean change from baseline
Measured continuously using a wearable activity monitor, calculated as percentage of time spent sitting or standing.
Measured: Continuously from enrollment to end of treatment at day 5.
Length of hospital stay
Length of hospital stay in days
Measured: At end of follow-up, 30 days after discharge
Pulmonary complications during admission
Number and type of pulmonary complications during admission
Measured: At end of follow-up, 30 days after discharge
Transfers to ICU
Participant transferred to ICU during admission yes/no?
Measured: At end of follow-up, 30 days after discharge
Readmission within 30 days
Participant readmitted within 30 days, yes/no
Measured: At end of follow-up, 30 days after discharge
Pain score during breathing exercise using Visual Analogue Score (VAS)
VAS pain score during breathing exercise (0-100mm). A higher score means a worse outcome.
Measured: Daily from baseline to end of treatment at day 5.
Powerless in Daily living questionnaire
Powerless in Daily living questionnaire (0-21), a higher score means a worse outcome.
Measured: Daily from baseline to end of treatment at day 5.
Quality of Recovery-15 questionnaire
Quality of Recovery-15 questionnaire (0-150), a higher score means a better outcome.
Measured: Daily from baseline to end of treatment at day 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start28 Mar 2022
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Why it stopped: Inclusion rate too low.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blunt Chest TraumaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194176
- Sponsor's protocol ID
- 112814
- Acronym
- VIREX PURE
- Status last verified
- Mar 2023
- First submitted
- 2 Jan 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable patient characteristics, questionnaire data, diaries and measurements will be shared in a pseudonimised manner in DANS EASY under restricted access
Publications
Groenveld TD, Smits IG, Scholten N, de Vries M, van Goor H, Stirler VM. Pulmonary and Physical Virtual Reality Exercises for Patients With Blunt Chest Trauma: Randomized Clinical Trial. JMIR Serious Games. 2024 Dec 9;12:e54389. doi: 10.2196/54389.
PubMed 39652866
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma
- ClinicalTrials.gov ID
- NCT05194176
- Acronym / sponsor ID
- VIREX PURE / 112814
- Conditions
- Blunt Chest Trauma
- Keywords
- Virtual Reality, Trauma, Pulmonary Recovery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rate too low.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blunt chest trauma comprises over 10% of all trauma patients presenting to emergency departments worldwide and is the most frequent injury in polytrauma patients. It is associated with high risk (>10%) of pulmonary complications such as pneumonia. Pillars of treatment are adequate pain relief, respiratory function exercises and rapid mobilisation through physiotherapy. Inadequate pain control can result in restricted ventilatory function and in reduced mobility, both resulting in a higher risk of particularly pulmonary complications. Virtual Reality (VR) might be an easy to use, individualized, and harmless technique that can facilitate pulmonary recovery and aid in the prevention of complications through reducing pain and promoting exercising. The investigators hypothesize that VR improves respiratory function and mobilisation in the post-acute phase of blunt chest trauma by distracting patients from pain and stress, and by stimulating pulmonary and physical exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will receive usual care. Patients will be instructed to perform respiratory exercises 8 times daily for 10 minutes and to extend these exercises 2 times daily with (sitting) physical exercises for an additional 10 minutes. Respiratory exercises include using incentive spirometry and exercises for deep breathing, huffing and coughing. Patients receive a leaflet with the exercises described and the exercises will be performed once daily under supervision of a physiotherapist. The other sessions will be unsupervised. |
| Virtual Reality | Experimental | Device: Virtual RealityThe intervention group will be instructed to perform the respiratory exercises using the VR-intervention 8 times daily for 10 minutes and to extend these exercises 2 times daily with (sitting) physical exercises for an additional 10 minutes. The respiratory exercises in VR are comparable to the exercises in usual care but performed in a virtual environment and without incentive spirometry. The physical exercises consist of several games through which patients are challenged to reach out to objects while engaging their core. Patients are allowed to continue these exercises or play some relaxation games for up to 30 minutes per session in total. The exercises will be performed once daily under supervision of a physiotherapist. The other sessions will be unsupervised. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to the trauma ward with sustained blunt chest trauma
- Age≥16
- Patient is willing and able to comply with the study protocol
Key exclusion criteria (6 listed)
- Neurotrauma with GCS ≤13
- History of dementia, seizures, epilepsy
- Severe hearing/visual impairment not corrected
- Head wounds or damaged skin with which comfortable and hygienic use is not possible.
- Stay at intensive care unit (ICU) during current hospital admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityFor all VR exercises a head mounted display (HMD), the PICO G2 4K (Barcelona, Spain) will be used. Together with SyncVRMedical (Utrecht, Netherlands) a VR dashboard has been created from which patients can chose the different exercises. | Device | Virtual Reality |
Primary outcome
Inspiration volume, mean change from baseline
Time frame: From baseline to end of treatment at day 5.
Mean change from baseline in inspiration volume in ml, measured with an incentive spirometer (Voldyne)
Inspiration volume, repeated measures over 5 days
Time frame: Twice daily from enrollment to day 5 of treatment
change in mean daily inspiration volume in mL, measured with an incentive spirometer (Voldyne)
8 secondary outcomes
Time spent sitting or standing, mean change from baseline
Time frame: Continuously from enrollment to end of treatment at day 5.
Length of hospital stay
Time frame: At end of follow-up, 30 days after discharge
Pulmonary complications during admission
Time frame: At end of follow-up, 30 days after discharge
Transfers to ICU
Time frame: At end of follow-up, 30 days after discharge
Readmission within 30 days
Time frame: At end of follow-up, 30 days after discharge
Pain score during breathing exercise using Visual Analogue Score (VAS)
Time frame: Daily from baseline to end of treatment at day 5.
Powerless in Daily living questionnaire
Time frame: Daily from baseline to end of treatment at day 5.
Quality of Recovery-15 questionnaire
Time frame: Daily from baseline to end of treatment at day 5.
Results and safety
The study was stopped early (reason given: Inclusion rate too low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Derived from this study: PubMed 39652866Groenveld TD, Smits IG, Scholten N, de Vries M, van Goor H, Stirler VM. Pulmonary and Physical Virtual Reality Exercises for Patients With Blunt Chest Trauma: Randomized Clinical Trial. JMIR Serious Games. 2024 Dec 9;12:e54389. doi: 10.2196/54389.
- Individual participant dataSharing planned: Yes. Non-identifiable patient characteristics, questionnaire data, diaries and measurements will be shared in a pseudonimised manner in DANS EASY under restricted access
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Blunt Chest Trauma, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusion rate too low.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiration volume, mean change from baseline (time frame: From baseline to end of treatment at day 5.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05194176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.