Virtual reality exposure before elective pediatric day-care surgery: effects on pre- and postoperative anxiety and pain

(Please also see METC protocol par. 1, which includes references)

Every year about 6000 children undergo surgery under general anesthesia in the
Erasmus MC - Sophia Children*s Hospital. About 50% to 70% of children
undergoing surgery experience elevated levels of anxiety and stress. Parents
are often anxious, which negatively influences the child*s anxiety. Children*s
preoperative anxiety is associated with less cooperation during induction of
anesthesia, increased risk of postoperative emergence delirium (ED), more
intense and prolonged postoperative pain, analgesic use, postoperative
maladaptive behavior, poorer recovery, and sleep disturbance. These adverse
outcomes indicate the urgent need to develop effective strategies to minimize
preoperative anxiety in children, and reduce postoperative pain.

It is well established that gradual exposure to feared situations is a very
effective way to reduce anxiety. However, gradually exposing children to the
aspects of the preoperative (e.g. waiting room, operating room, anesthesia) and
the postoperative (e.g. recovery room) procedures and environment is not
feasible, because this would interfere significantly with daily clinical
practice. Virtual Reality Exposure (VRE) provides a unique opportunity to
prepare children for their surgery in a very realistic, child friendly and
interactive way. This study will be the first, worldwide, to develop and test
the efficacy of VRE preparation for children undergoing surgery. This study is
in line with the renewed emphasis on patient- and family-centered care of the
Sophia Children*s Hospital.
Our hypotheses are: (1) VRE will be significantly more efficacious than care as
usual (CAU) on both the primary outcome (the child*s situational preoperative
anxiety) and secondary outcomes, and (2) children with unfavorable predictor
variables will benefit more from VRE.

The objective is:
(1) To test the efficacy of VRE versus CAU in 200 children undergoing surgery
on the anxiety level of the child during induction of anesthesia (primary
outcome), pre- and postoperative child anxiety, pre- and postoperative parental
anxiety, postoperative pain, postoperative ED, analgesic use, and health care
use (secondary outcomes).
(2) To examine predictors of VRE efficacy: socioeconomic status (SES), age,
sex, type of surgery, number of prior surgeries, child and parental anxiety,
and psychopathology in the previous six months.

(Please also see METC protocol par. 3 and fig. 1)

Single blinded randomised controlled trial (RCT) involving a psychosocial
intervention.

There will be five moments of assessment:
T1. At admission to the hospital (before intervention)
After T1 randomization will take place.
T2. After the VRE intervention or in case of CAU, without intervention,
approximately 15 minutes prior to entering the surgery room
T3. During induction of anesthesia, in the surgery room
T4. Postoperatively, in the recovery room
T5. Three days after surgery, at home

(Please also see METC protocol par. 5)

One group will receive Virtual Reality Exposure (VRE) preparation. VRE
preparation encompasses an animated virtual environment, using 3D glasses,
that mimics the environment of the operation theatre in the Sophia Children*s
Hospital, as well as procedures regarding induction of anesthesia.

The other group will receive care as usual (CAU).

The risks associated with participation can be considered negligible and the
burden can be considered minimal.

Risks: The aim of the study is that this Virtual Reality Exposure (VRE)
approach will diminish anxiety in children. However, it cannot be ruled out
that some children will become stressed and anxious during the VRE. If this is
the case, we will immediately terminate the VR procedure and comfort the child.
Therefore the risk associated with participation is negligible.

Burden: There are no extra visits to the hospital needed. All questionnaires
will be filled out at the day of admission to the hospital, or at home, three
days after surgery.
The burden for children is minimal, as they only rate their anxiety on a Visual
Analogue Scale (VAS) and pain on a Faces Pain Scale (FPS). The burden for
parents is also minimal, as they only fill out a number of questionnaires. In
total, the study will take about 45 minutes: VRE will take approximately 15
minutes - the other time will be spend on filling out questionnaires.