Primary Objective:To investigate the effect of respiratory and physical exercises in VR on pulmonary recovery compared to the standard of care of patients suffering from blunt chest trauma.Secondary Objective(s):- To investigate if VRx can improveā¦
ID
Source
Brief title
Condition
- Injuries NEC
- Thoracic disorders (excl lung and pleura)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
mean daily inspiration volume in mL, measured with an incentive spirometer
(Voldyne).
Secondary outcome
Patient mobility:Time spent lying, sitting and moving measured with a wearable
activity monitor (ActivPal/Activ8).
Clinical outcomes: Length of hospital stay in days, pulmonary complications
during admission, transfer to ICU, readmission within 30 days
Pain: VAS score during breathing exercise, analgesic use (paracetamol, NSAIDs,
opioids), use of add-on/escape medication
Activities of daily livin: Powerlessness in Daily Living questionnaire (PDL)
Patient reported outcomes: Quality of Recovery-15 questionnaire, treatment
satisfaction questionnaire
Safety outcomes: Reasons for withdrawal, adverse events during VR therapy incl.
virtual reality sickness questionnaire (VRSQ)
Barriers to implementation: Treatment adherence, measured by the number of
times pulmonary and physical exercise are performed, technical problems,
feedback on apps.
Background summary
Blunt chest trauma comprises over 10% of all trauma patients presenting to
emergency departments worldwide and is the most frequent injury (44.5%) in
polytrauma patients.The most frequent thoracic injuries are rib fractures,
pneumothorax and pulmonary contusion, with rib fractures being present in
40-80% of patients. Chest trauma is associated with high risk (>10%) of
pulmonary complications such as pneumonia, ARDS and patients often require
ventilatory support. Mortality after blunt chest trauma is 4-20%, with
pneumonia being its most important risk factor.
Management is mainly focussed on prevention of pulmonary complications. The
most important pillars herein are adequate pain relief, respiratory function
exercises and rapid mobilisation. Because these different aspects all affect
each other, they are targeted in care bundles. These care bundles improve
clinical outcomes and decrease ICU and hospital length of stay. Inadequate pain
control can result in restricted ventilatory function and in reduced mobility,
both adding to a higher risk of complications. Currently, multimodal analgesics
(i.e. different combinations of epidural analgesics, opioids, NSAIDs etc.) are
recommended for pain control. Epidural and systemic opioids are the most
frequently used modalities.However, especially opioids can have deleterious
side-effects such as sedation and respiratory depression, which directly
negatively affects pulmonary recovery. Additionally, side-effects such as
nausea and dizziness can make patients refrain from physical activity. As a
result, effective pain control without disrupting pulmonary recovery remains a
challenge in daily practice.
A second problem in the recovery after blunt chest trauma is the fact that
hospitalized patients with blunt chest trauma spend between 53-57% of the time
lying in bed, despite interventions to improve physical activity. Inactivity
can lead to general deconditioning and ultimately to complications, whereas
higher levels of physical exercise are associated with better functional
outcomes and reduced length of hospital stay. Furthermore, daily practice
learns that adherence to prescribed pulmonary and physical exercise is low.
Therefore, ongoing research is needed into new innovative methods that affect
all these pillars by reducing pain effectively and motivating patients to
exercise.
VR is a technique with the possibility to promote both physical and mental
wellbeing of patients with blunt chest trauma. The ability of VR to immerse
someone into another world brings opportunities that, amongst others, can
reduce acute pain and procedural pain, helps patients to relax and motivate
patients to do more physical exercises. VR has proven effective for reducing
procedural pain by distracting patients from the painful experience through an
immersive and playful environment. Exergaming, gaming that requires physical
exercise, has shown to improve patient adherence and physical fitness.
Furthermore, VR therapy (VRx) in an inhospital setting has shown to reduce pain
and anxiety and possibly length of stay. Another advantage of VRx is the few
side-effects, which are usually mild and transient.
To our knowledge VRx has not been administered to patients with chest trauma.
We hypothesize it might improve respiratory recovery by breaking the vicious
circle of pain, pain avoidance and passivity of patients with blunt chest
trauma. Respiratory and physical exercises can be made fun through VRx, while
distracting patients from pain and stress. The primary objective of this study
is to investigate if VR respiratory and physical exercises can improve the
pulmonary recovery in inpatients suffering from blunt chest trauma. Secondary
objectives are to investigate if VRx can improve patient mobility, clinical
outcomes, pain reduction, patient reported outcomes and to investigate the
safety of VRx and barriers to implementations, and last to generate hypotheses
which individual characteristics might be used to determine which patients can
benefit most from VR.
Study objective
Primary Objective:
To investigate the effect of respiratory and physical exercises in VR on
pulmonary recovery compared to the standard of care of patients suffering from
blunt chest trauma.
Secondary Objective(s):
- To investigate if VRx can improve mobility of patients recovering from blunt
chest trauma, compared to a control condition.
- To investigate if using VRx during different stages of inpatient
rehabilitation from blunt chest trauma can improve clinical outcomes, compared
to a control condition.
- To investigate if VRx can improve pain reduction in patients after blunt
chest trauma, compared to a control condition
- To investigate if VRx can improve patient reported outcomes of patients with
blunt chest trauma, compared to a control condition.
- To investigate the safety of VR treatment
- To generate hypotheses which individual characteristics might be used to
determine which patients can benefit most from VR.
- To investigate barriers to implementation
Study design
Randomized controlled parallel design.
Intervention
All patients from both groups will receive care according to existing
guidelines (Guideline: *thoraxwandletsels*). Similarly, pain management will be
according to the standardized Radboudumc guideline for acute pain in adults
(Guideline: *Acute pijn bij volwassenen*). Only the treatment regarding the
breathing exercises will differ between control and intervention group.
Participants will be randomly assigned to the control group or intervention
group.
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.
For all VR exercises a head mounted display (HMD), the PICO G2 4K (Barcelona,
Spain) will be used. Together with SyncVR Medical (Utrecht, Netherlands) a VR
dashboard has been created from which patients can chose the different
exercises
Study burden and risks
Participants in the intervention group may benefit in the form of accelerated
pulmonary recovery, increased mobility and decreased post-traumatic pain. The
results from the study will provide new insights into feasibility and
effectivity of VR therapeutics in recovery after blunt chest trauma. The risks
for participants are negligible. We expect no or only minimal adverse effects
from the VR intervention. The burden of the participants associated with this
study is related to measurements of endpoints and, in the intervention group,
the time spent on the VR intervention. The questionnaires will take
approximately 5 minutes to fill out at the beginning and 10 minutes at the end
of the study. Filling out the diary will take approximately 5 minutes daily.
The intervention group will spend approximately 100 minutes on VR therapy
daily. However, part of this will be spent on respiratory exercises which would
normally also take approximately 40-80 minutes daily. The participants are
allowed to use VR longer, with an advised daily maximum of 240 minutes spread
over 8 sessions.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
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
- Headwounds 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL80011.091.21 |