Smartphone virtual reality exposure before paediatric surgery: effects on pre- and post-procedural pain and anxiety

Fifty percent of children and 80% of adolescents experience anxiety and
distress prior to surgery. Preoperative anxiety is related to higher levels of
post-operative pain and sleep problems. We recently showed that half as many
children that received preoperative Virtual Reality Exposure (VRE) prior to
anaesthesia for tonsillectomy needed morphine compared to children who did not
receive this preparation. However, there are some disadvantages to this VRE,
e.g. it is installed on a PC at the Sophia Children*s Hospital, which limits
the implementation of this intervention. Therefore, we further developed this
VRE into a smartphone app with the aim of improved exposure to the VRE (at
home, at a child*s own pace) and reducing healthcare costs.

This study aims to test the efficacy of this smartphone VRE application (sVRE)
versus care as usual (CAU) in children undergoing major and/or painful surgery
on postoperative pain and analgesia. Our hypotheses are: (1) sVRE will be
significantly more efficacious than care as usual (CAU) on both primary
(postoperative pain) and secondary outcomes, and (2) children with unfavourable
predictor variables will benefit more from sVRE.

The objectives of this study are to (1) test the efficacy of sVRE versus CAU in
180 children undergoing surgery on the postoperative pain of the child (primary
outcome), postoperative analgesics use, anxiety level of the child during
induction of anaesthesia, compliance during induction of anaesthesia,
postoperative sleep problems, and length of hospital stay (secondary outcomes).
(2) To examine predictors of VRE efficacy, including socioeconomic status
(SES), age, sex, number of prior surgeries, preoperative child and parental
anxiety, and preoperative sleep problems.

A multicentre, randomized controlled trial (RCT) in which 180 participants (128
patients undergoing (adeno)tonsillectomy and 52 patients undergoing scoliosis
surgery) will be allocated to either the sVRE intervention condition (n=90) or
CAU (n=90). The longitudinal design will include six measurements points:
Pre-intervention, one week before surgery (T0); post-intervention, prior to
entering surgery room (T1); during induction of anaesthesia (T2);
postoperatively in the recovery room (T3); 5 days postoperative (T4); 21 days
postoperative (only for scoliosis surgery.

sVRE preparation encompasses a virtual, three-dimensional environment that
replicates the operating rooms of the Sophia Children*s Hospital and the
Maasstad Hospital. This virtual 3D environment contains the waiting room,
corridor to the operating room, operating room and recovery room. The
procedures children will undergo before they are induced for anaesthesia are
also animated in the sVRE environment. Children can use the VR preparation at
home with a smartphone VR app and cardboard VR glasses. The smartphone app
provides the child the opportunity to fully look around in the virtual 3D
environment and thus explore the sVRE environment at his own pace, in a
child-friendly way, as often as the child wants.

The risks are negligible and the burden is minimal. All children receive care
as usual, and those who are randomized to the sVRE condition will wear VR
glasses to use the sVRE application. Since this VRE is performed at home, there
is a risk that children run into tables, chairs or other furniture. To limit
this risk, parents and children are instructed to only use the sVRE
intervention when an adult/guardian is present. Moreover, it cannot be ruled
out that some children will become stressed and anxious during the VR. If this
is the case, parents are instructed to immediately terminate the sVRE procedure
and comfort the child. If there is a need for acute psychosocial care, adequate
referral will be arranged. If children will be allocated to the CAU group, no
risks are incurred beyond those associated with CAU.

The only potential burden for parents and children are the short assessments.
The burden for children is minimal, as they only rate their pain and anxiety on
a NRS and Visual Analogue Scale (VAS) and complete questionnaires on the user
experience and sleep. The burden for parents is also minimal, as they only
complete a number of questionnaires.