Smartphone virtual reality exposure before MRI: effects on pre- and periprocedural anxiety. A multicenter RCT

Every year about 5000 children undergo an MRI in the Erasmus MC - Sophia
Children*s Hospital and the Amsterdam UMC - Emma Children*s Hospital. An MRI
scan often is a frightening experience for a child. Children must lie in a
narrow tube for an extended period of time, scanning is accompanied by very
loud, unpleasant noises and often an infusion must be inserted to administer
contrast fluid. Many children panic, have claustrophobic feelings and are
agitated. As a result, scanning sequences need to be aborted, and/or the
quality of the obtained MRI images is insufficient. Research shows that about
1 in 4 children need to be sedated or given anesthesia prior to and during an
MRI procedure. Anesthesia carries inherent risks, such as gastrointestinal
complaints, emergence delirium leading to prolonged hospitalization and in
exceptional cases(<1 / 10,000), death.
It is well established that gradual exposure to feared situations is a very
effective way to reduce anxiety. However, gradually exposing all children to
the aspects of an MRI is not feasible, because this would interfere
significantly with daily clinical practice. Virtual Reality Exposure (VRE)
provides a unique opportunity to prepare children for MRI in a very realistic,
child friendly and interactive way. This study will be the first, worldwide, to
develop and test the efficacy of smartphone VRE preparation for children
undergoing MRI.

This study aims

(1) To investigate the effectiveness of smartphone VRE preparation, compared
with the regular care (information letter), on reducing anxiety for an MRI
(primary outcome measure), anxiety in the child and the parent before and after
MRI, use of sedation and narcosis, quality of MRI images and duration of MRI
examination (secondary outcome measures).


(2) To investigate the predictor variables for the effectiveness of VRE:
socioeconomic status, age, gender, type
MRI, number of previous MRIs, anxiety of the child and the parent and
psychopathology of the child in the last six
months.

Single-blind randomized study with psychosocial intervention and control group
(RCT).

There will be three measurement moments:

T1 = measurement at home prior to smartphone VR intervention
T2 = measurement prior to MRI in the hospital
T3 = measurement after the MRI in the hospital

One group receives the smartphone Virtual Reality Exposure (VRE) preparation.
The VRE intervention consists of a virtual preparation
by interactively viewing the MRI environment and procedures by means of a
cardboard that is attached to a smartphone. This intervention takes place in
the home situation and children can see the VR preparation as often as desired.

The other group receives regular care (information letter that is sent to
parents).

The risks associated with participation are negligible and burden is minimal.

Risks: The goal is to use smartphone Virtual Reality Exposure (VRE) to reduce
anxiety. However, it can not be excluded that
some children become tense or scared during the VRE. We will inform parents
that children may become anxious about the
VR intervention. In that case we advise them to terminate the VRE procedure and
to reassure the child. In a current study of VR in preparation for children on
an operation, it turned out to be hardly the case that children became anxious
about the VRE intervention. Risks related to participation are therefore
negligible.


Burden: Patients and their parents do not have to come to the hospital extra.
All measurements take place on the day of
the MRI itself or at home. The tax for children is minimal because they only
have to indicate their anxiety level on a Visual Analogue Scale (VAS). The tax
for parents is also minimal because they only have to fill out a number of
questionnaires.
Parents and their children will spend a total of approximately 45 minutes on
the research, namely on undergoing the
VR preparation (15 min) and the different questionnaires.