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

Primary Purpose

Blunt Chest Trauma

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual Reality
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blunt Chest Trauma focused on measuring Virtual Reality, Trauma, Pulmonary Recovery

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radboud university medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Virtual Reality

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Inspiration volume, mean change from baseline
Mean change from baseline in inspiration volume in ml, measured with an incentive spirometer (Voldyne)
Inspiration volume, repeated measures over 5 days
change in mean daily inspiration volume in mL, measured with an incentive spirometer (Voldyne)

Secondary Outcome Measures

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.
Length of hospital stay
Length of hospital stay in days
Pulmonary complications during admission
Number and type of pulmonary complications during admission
Transfers to ICU
Participant transferred to ICU during admission yes/no?
Readmission within 30 days
Participant readmitted within 30 days, yes/no
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.
Powerless in Daily living questionnaire
Powerless in Daily living questionnaire (0-21), a higher score means a worse outcome.
Quality of Recovery-15 questionnaire
Quality of Recovery-15 questionnaire (0-150), a higher score means a better outcome.

Full Information

First Posted
January 2, 2022
Last Updated
March 6, 2023
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05194176
Brief Title
The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma
Acronym
VIREX PURE
Official Title
The Effect of Virtual Reality on Pulmonary Recovery and Mobility in Patients With Blunt Chest Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Inclusion rate too low.
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Chest Trauma
Keywords
Virtual Reality, Trauma, Pulmonary Recovery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Virtual Reality
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Virtual Reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inspiration volume, mean change from baseline
Description
Mean change from baseline in inspiration volume in ml, measured with an incentive spirometer (Voldyne)
Time Frame
From baseline to end of treatment at day 5.
Title
Inspiration volume, repeated measures over 5 days
Description
change in mean daily inspiration volume in mL, measured with an incentive spirometer (Voldyne)
Time Frame
Twice daily from enrollment to day 5 of treatment
Secondary Outcome Measure Information:
Title
Time spent sitting or standing, mean change from baseline
Description
Measured continuously using a wearable activity monitor, calculated as percentage of time spent sitting or standing.
Time Frame
Continuously from enrollment to end of treatment at day 5.
Title
Length of hospital stay
Description
Length of hospital stay in days
Time Frame
At end of follow-up, 30 days after discharge
Title
Pulmonary complications during admission
Description
Number and type of pulmonary complications during admission
Time Frame
At end of follow-up, 30 days after discharge
Title
Transfers to ICU
Description
Participant transferred to ICU during admission yes/no?
Time Frame
At end of follow-up, 30 days after discharge
Title
Readmission within 30 days
Description
Participant readmitted within 30 days, yes/no
Time Frame
At end of follow-up, 30 days after discharge
Title
Pain score during breathing exercise using Visual Analogue Score (VAS)
Description
VAS pain score during breathing exercise (0-100mm). A higher score means a worse outcome.
Time Frame
Daily from baseline to end of treatment at day 5.
Title
Powerless in Daily living questionnaire
Description
Powerless in Daily living questionnaire (0-21), a higher score means a worse outcome.
Time Frame
Daily from baseline to end of treatment at day 5.
Title
Quality of Recovery-15 questionnaire
Description
Quality of Recovery-15 questionnaire (0-150), a higher score means a better outcome.
Time Frame
Daily from baseline to end of treatment at day 5.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Radboud university medical center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Non-identifiable patient characteristics, questionnaire data, diaries and measurements will be shared in a pseudonimised manner in DANS EASY under restricted access

Learn more about this trial

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

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