Primary- Does the application of Virtual Reality (VR) reduce anxiety in patients undergoing treatment for traumatic injury in the emergency department compared to patients not using VR headset? Secondary- Does the use of Virtual Reality (VR) lead to…
ID
Source
Brief title
Condition
- Fractures
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anxiety reduction (Δ anxiety = preprocedural STAI-C - postprocedural STAI-C).
The anxiety score is measured with STAI-C (State-Trait Anxiety Inventory -
Children, abbreviated version). The STAI-C score is measured before and after
the procedure. The questionnaire consists of 6 items with 3 options:
1) I feel: very calm, calm or not calm
2) I am: very tense, tense or not tense
3) I am: very confused, confused or not confused
4) I feel: very relaxed, relaxed or not relaxed
5) I feel: very satisfied, satisfied or not satisfied
6) I am: very worried, worried or not worried
Secondary outcome
- Postprocedural anxiety score (STAI-C)
- Painreduction (postprocedural painscore - preprocedural pain score)
- Pain score after treatment, using WONG-Baker Faces Scale Indicator for Pain
- Procedural distress (distress) and coping of a child periprocedural, measured
with the CAMPIS-SF score (Child Adult Medical Procedure Interaction Scale -
Short Form).
- Coping and distress promoting factors by parents and healthcare provider
measured with the CAMPIS-SF
- VRMS (virtual reality motion sickness) during the procedure
- Treatment satisfaction, both child and parents
- VR headset use satisfaction, by child, parents and healthcare provider
- Duration of treatment in minutes (start treatment to discharge)
- Future perspective of using a VR headset for a medical intervention
Background summary
Children often undergo painful and stressful procedures in the emergency
department. There has been much focus on providing trauma-free care in
hospitalised children, as inadequate pain management can lead to traumatic
experiences, increased anxiety and stress, decreased patient satisfaction and,
in the long term, even risk of care avoidance. Moreover, exposure to the
procedure contributes to increasing levels of procedural distress and,
consequently, the intensity of pain.
A pain-free procedure using 'procedural sedation and analgesia' (PSA) is not
feasible for every patient in the emergency department. This is partly due to
the time burden of one to two hours and the presence of trained staff.
Furthermore, PSA is not strictly pain-free: intravenous access must be created.
Also, PSA is not desirable in every patient because of the risks of
complications (cardiopulmonary, anaphylaxis or aspiration). Careful
consideration must be made per patient.
Recent studies have shown that Virtual Reality (VR) is an effective and
non-invasive distraction method to reduce pain and anxiety perception in
children during various medical procedures such as blood sampling, dressing
change in burns and obtaining intravenous access in chemotherapy. The advantage
of a VR headset is that a virtual 3D environment is created and thus the child
is not exposed to the medical procedure. This has also led to higher patient
satisfaction in previous studies. Given these experiences, VR headsets could
provide a solution for anxious and painful patients who are not eligible for
PSA in the emergency department.
To date, no studies have been conducted on the use of a VR headset in the
treatment of traumatic injuries in children. It is hypothesised that the use of
a VR headset will reduce the anxiety, pain and procedural distress levels in
children undergoing trauma-related treatment in the emergency department.
Study objective
Primary
- Does the application of Virtual Reality (VR) reduce anxiety in patients
undergoing treatment for traumatic injury in the emergency department compared
to patients not using VR headset?
Secondary
- Does the use of Virtual Reality (VR) lead to pain reduction in children
undergoing treatment for traumatic injury in the emergency department compared
to the non-VR group
- Is there a difference in post-procedural anxiety and painscore in children
undergoing treatment for traumatic injury (between the groups)?
- Does the use of VR headset lead to less procedural distress and better coping
in contrast to the non-VR group?
- Is there a difference in duration of treatment and amount of pain relief
between the two groups?
- Investigating patient satisfaction and satisfaction of children, parents and
caregivers regarding the use of VR headset
Study design
* A single-centre prospective randomised trial (n=112)
* This study is conducted at the emergency department in Onze Lieve Vrouwe
Gasthuis (OLVG)
Intervention
VR versus non-VR group (care as usual)
Study burden and risks
Wearing a VR headset is not associated with any risks. Desorientation and
balance disturbance is avoided by having the patient sit or lie down during the
procedure. The included patients answer some questions before and after
treatment of the traumatic injury. Completing this questionnaire takes about 15
minutes per patient. The patients won't receive compensation for participating
in this study.
Oosterpark *
Amsterdam 1091 AC
NL
Oosterpark *
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
Aged 8-18 years
Medical treatment required after traumatic injury (e.g. wound closure, closed
reduction of a fracture / luxation)
Exclusion criteria
o Contact isolation
o Resistance
o PSA (Procedural Sedation and Analgesia) with propofol, ketamin and/or
midazolam
o Language barrier
o Intellectual disability
o History of epilepsy
o Hearing impairment
o Visual impairment
o High energy injury
Design
Recruitment
Medical products/devices used
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 | NL83738.100.23 |