The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma

Conditions
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Blunt Chest Trauma

Intervention / Treatment
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* Device: Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to the trauma ward with sustained blunt chest trauma Age≥16 Patient is willing and able to comply with the study protocol Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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. | |
| Experimental: Virtual Reality<br>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. | Device: Virtual Reality<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiration volume, mean change from baseline | Mean change from baseline in inspiration volume in ml, measured with an incentive spirometer (Voldyne) | 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) | Twice daily from enrollment to day 5 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Continuously from enrollment to end of treatment at day 5. | 
| Length of hospital stay | Length of hospital stay in days | At end of follow-up, 30 days after discharge | 
| Pulmonary complications during admission | Number and type of pulmonary complications during admission | At end of follow-up, 30 days after discharge | 
| Transfers to ICU | Participant transferred to ICU during admission yes/no? | At end of follow-up, 30 days after discharge | 
| Readmission within 30 days | Participant readmitted within 30 days, yes/no | 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. | 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. | 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. | Daily from baseline to end of treatment at day 5. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Trauma, Pulmonary Recovery