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

Sponsor
Radboud University Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05194176
Collaborator
(none)
126
1
2
10.2
12.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
126 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

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

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
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.

Outcome Measures

Primary Outcome Measures

  1. Inspiration volume, mean change from baseline [From baseline to end of treatment at day 5.]

    Mean change from baseline in inspiration volume in ml, measured with an incentive spirometer (Voldyne)

  2. Inspiration volume, repeated measures over 5 days [Twice daily from enrollment to day 5 of treatment]

    change in mean daily inspiration volume in mL, measured with an incentive spirometer (Voldyne)

Secondary Outcome Measures

  1. Time spent sitting or standing, mean change from baseline [Continuously from enrollment to end of treatment at day 5.]

    Measured continuously using a wearable activity monitor, calculated as percentage of time spent sitting or standing.

  2. Length of hospital stay [At end of follow-up, 30 days after discharge]

    Length of hospital stay in days

  3. Pulmonary complications during admission [At end of follow-up, 30 days after discharge]

    Number and type of pulmonary complications during admission

  4. Transfers to ICU [At end of follow-up, 30 days after discharge]

    Participant transferred to ICU during admission yes/no?

  5. Readmission within 30 days [At end of follow-up, 30 days after discharge]

    Participant readmitted within 30 days, yes/no

  6. Pain score during breathing exercise using Visual Analogue Score (VAS) [Daily from baseline to end of treatment at day 5.]

    VAS pain score during breathing exercise (0-100mm). A higher score means a worse outcome.

  7. Powerless in Daily living questionnaire [Daily from baseline to end of treatment at day 5.]

    Powerless in Daily living questionnaire (0-21), a higher score means a worse outcome.

  8. Quality of Recovery-15 questionnaire [Daily from baseline to end of treatment at day 5.]

    Quality of Recovery-15 questionnaire (0-150), a higher score means a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Radboud university medical center Nijmegen Gelderland Netherlands 6525 GA

Sponsors and Collaborators

  • Radboud University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT05194176
Other Study ID Numbers:
  • 112814
First Posted:
Jan 18, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Radboud University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2022