Virtual reality (VR) to reduce anxiety in children in the plaster room

Fractures occur frequently in children in the Netherlands. In our hospital we
see about 2000 fractures in children each year. Most fractures are treated with
plaster, sometimes in combination with Kirschner wires. Kirschner wires or
k-wires are used to fixate some displaced fractures. The k-wires are often
removed in the plaster room, right after the plaster is removed. The
application or removal of plaster (and k-wires) is often an anxious experience
for children, particularly under the age of 13. In order to improve the quality
of the healthcare for children with fractures who have to undergo plaster
treatment, a method to effectively reduce this anxiety in children has yet to
be found.
Different methods have been researched to reduce anxiety in children in
clinical situations. Many of these have proven to be ineffective, such as using
midazolam and showing an instructional video ahead of the procedure. However, a
few methods were found to have a positive effect on the anxiety: watching
videos on a smartphone or tablet during the procedure and using hearing
protectors during the removal of a cast. Since both visual distraction and
noise reduction seem to have a positive effect on the anxiety levels in
children, researching the effect of Virtual Reality goggles connected to a pair
of headphones is a logical next step.
Virtual Reality (VR) goggles are used in clinical settings to distract patients
from anxious situations. A positive effect of VR goggles on anxiety and pain
perception - and therefore on the quality of healthcare - is shown in children
in several other situations, such as blood draw, dental procedures,
vaccinations and treatment of burns. The use of VR goggles has shown to be more
effective in reducing anxiety and pain perception than watching a video on a
tablet. However, the effect of VR goggles during plastering specifically, has
not yet been researched. Our hypothesis is that the use of VR goggles will
lower the anxiety of children in the plaster room.

Primary Objective:
The primary objective of this study is to evaluate the difference in anxiety
levels in children in the plaster room with or without distraction with VR
goggles.

Primary outcome parameter:
Child*s anxiety score right after the plaster intervention, using the Child
Fear Scale (CFS).

Secondary Objective(s):
The secondary objectives of this study are evaluating the difference in anxiety
and pain levels in children, the difference in amount of satisfaction from the
child and the parent(s), and the difference in heart rates of the children in
the plaster room, with or without distraction with VR goggles.

Secondary outcome measures:
- Anxiety reduction (child) (difference between the CFS score before and after
the plaster intervention)
- NRS Pain (child) (right before and after the plaster intervention)
- NRS Satisfaction (child and parent) (right after the plaster intervention)
- Heart rate (child) (during the plaster intervention)

The study design is a randomised controlled study. The randomisation will have
a build-in stratification, to make sure that the two groups are equal when it
comes to the different ages and whether k-wires are removed. The control group
will include the 150 children who will receive standard treatment for a
fracture in the plaster room. The intervention group will include the 150
children who will get VR goggles and headphones during the procedure on top of
the standard treatment.
Before and after the plaster intervention, we conduct a short questionnaire
with the patients and parents. During the plaster intervention, all patients
will get a finger pulse oximeter to measure their pulse during the procedure.
Both age groups (5-11 and 12-17 years old) will have a choice between two
videos of about 20 minutes long. The video length is based on the maximum
length of the plaster intervention. The videos the children can choose between
are single episodes of different series on Netflix. The content of the video is
chosen based on Netflix recommendations and is screened to make sure the
content is appropriate for the hospital setting and the age group. The age
groups have different choices of videos and the video that is chosen will be
recorded. The following videos are selected for the age groups:
- Age 5-11: Masha and the Bear season 1 episode 2, The Thundermans season 1
episode 2.
- Age 12-17: Modern Family season 1 episode 2, Brooklyn Nine-Nine season 1
episode 2.

The burden associated with participation is having to fill out short surveys
and the addition of the finger pulse oximeter and for the intervention group
also the VR goggles and headphones. The treatment itself and the follow up are
unchanged.
The benefit of the study is to provide an answer to the question if Virtual
Reality has a positive effect on the anxiety level of children in the plaster
room.