Virtual Reality to Reduce Pain and Anxiety During Acute Pain Episodes in Patients with Sickle Cell Disease

Sickle cell disease (SCD) patients can suffer from vaso-occlusive crises (VOC),
extremely painful acute episodes that can occur frequently (3x/year),
unexpectedly, and last from hours until days . Periodic episodes of painful
crises negatively impact the quality of life and may cause negative long-term
effects such as chronic pain syndrome, anxiety and psychological distress that
can last into adulthood. Early interventions in children may influence pain
perception positively throughout life and may help individuals with SCD to
manage their pain and enhance their confidence and resilience.
Adequate management of acute pain in SCD patients is difficult because of its
complex nature as a result of its biological, psychological and social
components. As pharmacological therapy is insufficient to manage all the
aspects of pain, a comprehensive pain management plan is required. Virtual
Reality (VR) technology, via distraction, can produce an analgesic effect in
patients with pain. This effect has been long studied and also implemented
into clinical care, however not within the SCD population. VR has the potential
to more effectively reduce sickle cell-related pain and anxiety during a
vaso-occlusive crisis. If successful, VR technology can be easily implemented
into clinical practice and will contribute to the urgent clinical need to
optimize treatment of painful crisis in individuals with SCD.

The primary objective is to investigate the efficacy of VR, complementary to
standard care, in reducing intensity of pain in SCD patients hospitalized with
VOC compared to the efficacy of another distraction method (tablet use) next to
standard care. As secondary objectives we will investigate anxiety, total
opioid use, length of stay, incidence of complications (including intensive
care unit admission, need for blood transfusion, and acute chest syndrome), and
the cost-effectiveness of this therapy. The VR sessions* feasibility,
acceptability, tolerability and satisfaction will be investigated and compared
with control group.

The study concerns a single centre, randomised controlled trial (RCT).

Control group (standard care + tablet): 3 tablet-session per day, lasting 15
minutes. Before and after every session they will answer about their pain and
anxiety level. Every day they will answer about their health-related quality of
life using (less than 2 minutes). They will also answer, at admission and
discharge, to an anxiety questionnaire. At admission, a short socio-demographic
list will also be answered by patient/parents. At discharge they will be
briefly interviewed about their hospitalization experience and the use of the
tablet.
Intervention group (standard care + VR): 3 VR-sessions per day, lasting 15
minutes. Before and after every session they will answer about their pain and
anxiety level. Every day they will answer about their health-related quality of
life using (less than 2 minutes). They will also answer, at admission and
discharge, to an anxiety questionnaire. At admission, a short socio-demographic
list will also be answered by patient/parents. At discharge they will be
briefly interviewed about their hospitalization experience and the use of the
VR.

The risk of participation in this study is expected to be negligibly low. VR
technology does not impose any life-threatening or other major risks. The user
of the VR glasses can possibly experience complaints of nausea and dizziness.
This is called motion sickness, and the side-effects of VR are comparable to
the symptoms of carsickness or seasickness. Motion sickness refers to symptoms
that can occur during the experience of a virtual environment. The main cause
is the conflict of the visual feeling and the physical feeling that you can
experience of the virtual environment. When those complaints occur, the
intervention can be stopped immediately. The chance of injury by falling of the
hospital bed is very small as patients will use the VR glasses while seated or
in bed (while using hospital bed side rails), and we will not use intense
movement-requiring software. Possible skin and/or eye contamination while using
the device will be prevented by the use of hairnets and proper disinfection.
Age appropriate software will be downloaded and made available in accordance
with advice from SyncVR. With the least risk of a possible harmful effect of
the glasses, the VR intervention will be stopped. Even though both pain and
anxiety levels will be investigated daily, we have designed this study to be as
less of a burden to the patient as possible. Pain level will be measured each
time using a NRS that is estimated to take around 30 seconds to be answered.
The anxiety questionnaires, PROMIS Anxiety Pediatric Custom Short-form 8/PROMIS
Anxiety Short-form 8a, are estimated to take around 2 minutes to be answered,
and will only be fully answered in the first 24h of admission and at discharge.
One item from the questionnaire PROMIS Anxiety Pediatric Custom Short-form 8
questionnaire (*I felt scared**) will be asked before and after intervention,
but it also supposed to be answered in less than 30 seconds. Every day,
participants will answer about health-related quality of life by answering the
EQ-5D questionnaire, taking less than 2 minutes. At admission, both groups
will answer to a short socio-demographic questionnaire, containing only 4
questions. The VR/tablet interview is also supposed to be answered without
taking much time from the patient, during less than 15 minutes. The
parents/companions of the participants will also be quickly asked, at
discharge, how many days were they absent from work because of the
hospitalization. Benefits of participating in this study can occur in short-
and long-term . The use of VR technology during hospitalization for VOC pain
management, if our hypothesis is correct, can lead to reduction of pain,
reduction of anxiety, total dosage of opioids, LOS, and incidence of
complications. In long-term, participating of this study can help the future
development of non-invasive technologies and the implementation of a better
pain management plan for SCD patients.
In this way, the possible risks and burdens are outweighed by the benefits
reached.