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

Blunt Chest Trauma Clinical Trial

— VIREX PURE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05194176
• Other study ID #: 112814
• Status: Terminated
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: February 23, 2023

Study information

• Verified date: March 2023
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: February 23, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blunt Chest Trauma
• Thoracic Injuries
• Wounds and Injuries

Intervention

Device:
• Virtual Reality
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.

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	Length of hospital stay	Length of hospital stay in days	At end of follow-up, 30 days after discharge
Secondary	Pulmonary complications during admission	Number and type of pulmonary complications during admission	At end of follow-up, 30 days after discharge
Secondary	Transfers to ICU	Participant transferred to ICU during admission yes/no?	At end of follow-up, 30 days after discharge
Secondary	Readmission within 30 days	Participant readmitted within 30 days, yes/no	At end of follow-up, 30 days after discharge
Secondary	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.
Secondary	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.
Secondary	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.