The aim of the current study is to explore the effect of virtual reality on pain in children who undergo an intrathecal pump refill compared to usual care and distraction.
Virtual reality (VR) is a technological rehabilitation tool that allows the user to experience the interaction with a computer-generated environment. It may provide some advantages over conventional care: it allows the simulation of realistic environments and patients feel more motivated by this kind of virtual environment. VR constitutes an enriched environment with augmented multiple sensory feedbacks (auditory, visual, tactile VR enriched environment) that has already shown some efficiency in reducing chronic pain. There is mounting evidence from acute pain conditions, such as wound care, that VR could play a role as an additional treatment method to relieve pain A possible explanation for its mechanism of action is provided by "the gate-theory of attention". VR reduces the perception of pain by diverting attention away from the pain. Most children experience pain and fear when receiving a medical treatment; two feelings which are closely related and affecting one another. Moreover, children often describe procedures involving needles as the most stressful portion of the hospital experience. Children who have been implanted with an intrathecal baclofen (ITB) pump, need to come to the hospital for a refill approximately every 3 months, depending on the exact dose. During the refill, the physician places a needle directly into the reservoir to refill the pump. To alleviate the pain and fear with these refill procedures, it is hypothesized that VR could alleviate pain and make these refills more feasible. Therefore, the aim of this study is to evaluate whether VR is reducing pain during a refill procedure, in children receiving intrathecal drug delivery compared to usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
VR game
Video
daily routine care for pump refill
Universitair Ziekenhuis Brussel
Jette, Belgium
Pain intensity
Pain intensity will be assessed with the Wong-Baker FACES scale in children, parents, physician and researcher, to evaluate differences in the 3 conditions (usual refill, refill with VR and refill with distraction).
Time frame: Through study completion, an average of 6 months.
Procedural pain
Procedural pain during refill is assessed with the Face, Legs, Activity, Cry, Consolability scale.
Time frame: Through study completion, an average of 6 months.
Fear
The degree of fear will be measured using the Child Fear Scale, based on reporting from the child and parent.
Time frame: Through study completion, an average of 6 months.
Anxiety
The Children's Anxiety Meter (CAM) will be used to measure anxiety. This scale will be filled in by children and parents.
Time frame: Through study completion, an average of 6 months.
Statisfaction
The statisfaction will be evaluated by two questions, scoring on a 5-point Likert agreement scale, by the children, parents and physician after the refill with VR and after the refill with distraction.
Time frame: Through study completion, an average of 6 months.
Adverse events
The incidence of adverse events (nausea, vomiting, motion sickness, dizziness, seizure) will be evaluated after the refill with VR.
Time frame: Through study completion, an average of 6 months.
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