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

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 Overview

• Status: Recruiting
• Conditions: Blunt Chest Trauma
• Intervention / Treatment: Device: Virtual Reality

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tjitske Groenveld, MD; Phone Number: +31243667331; Email: tjitske.groenveld@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Recruiting
      • Radboud University Medical Center
      • Contact: Groenveld, MD; Email: tjitske.groenveld@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Virtual Reality; Trauma; Pulmonary Recovery
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries
• Other Study ID Numbers: 112814

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Non-identifiable patient characteristics, questionnaire data, diaries and measurements will be shared in a pseudonimised manner in DANS EASY under restricted access
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No