Skip to main content
Clinical Trials/NCT04737668
NCT04737668CompletedNot Applicable

Virtual Reality During Intrathecal Pump Refills in Children: a Randomised Controlled Trial With Crossover Design

Moens Maarten1 site in 1 country6 target enrollmentStarted: February 10, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
6
Locations
1
Primary Endpoint
Pain intensity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Usual care

Other

Pump refill will be performed as usual.

Intervention: Intrathecal pump refill (Other)

Virtual Reality

Other

Children will play a commercially available VR game during pump refill

Intervention: Intrathecal pump refill with Virtual Reality (Other)

Distraction

Other

Children will watch a commercial 360° music video on YouTube during pump refill

Intervention: Intrathecal pump refill with distraction (Other)

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Through study completion, an average of 6 months.

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).

Secondary Outcomes

  • Anxiety(Through study completion, an average of 6 months.)
  • Fear(Through study completion, an average of 6 months.)
  • Statisfaction(Through study completion, an average of 6 months.)
  • Procedural pain(Through study completion, an average of 6 months.)
  • Adverse events(Through study completion, an average of 6 months.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Moens Maarten

principal investigator

Universitair Ziekenhuis Brussel

Study Sites (1)

Loading locations...

Similar Trials