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

NCT05194176 | Terminated DMC

• 1 other identifier: 112814
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blunt Chest Trauma

Keywords

Virtual Reality; Trauma; Pulmonary Recovery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Time spent sitting or standing, mean change from baseline

  Continuously from enrollment to end of treatment at day 5.

• Length of hospital stay

  At end of follow-up, 30 days after discharge

• Pulmonary complications during admission

  At end of follow-up, 30 days after discharge

• Transfers to ICU

  At end of follow-up, 30 days after discharge

• Readmission within 30 days

  At end of follow-up, 30 days after discharge

Study Arms (2)

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.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

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.

Virtual Reality

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to the trauma ward with sustained blunt chest trauma
• Age≥16
• Patient is willing and able to comply with the study protocol

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39652866 DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: January 18, 2022
• Study Start: March 28, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: March 8, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE

Locations

NL (1)