Clinical trial NCT04737668: Virtual Reality During Intrathecal Pump Refills in Children
Official title: Virtual Reality During Intrathecal Pump Refills in Children: a Randomised Controlled Trial With Crossover Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Virtual Reality
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 6
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Children with cerebral palsy between 8 and 16 years who have an implanted pump for intrathecal drug delivery
* Child and parents have been informed of the study procedures and have given written informed consent
* Child and parents willing to comply with study protocol
* Child and parents are able to speak Dutch/French (questionnaires)
* Cognitive and language functioning enabling communication between the physician/researcher and the child

Exclusion Criteria:

* Children with susceptibility to motion sickness or cyber-sickness
* Children with susceptibility to claustrophobia
* History of seizures/epilepsia

Primary outcomes:
measure: Pain intensity
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
measure: Procedural pain
timeFrame: Through study completion, an average of 6 months.
measure: Fear
timeFrame: Through study completion, an average of 6 months.
measure: Anxiety
timeFrame: Through study completion, an average of 6 months.
measure: Statisfaction
timeFrame: Through study completion, an average of 6 months.
measure: Adverse events
timeFrame: Through study completion, an average of 6 months.
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
References: