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Completed

NCT Number: NCT04737668

Virtual Reality During Intrathecal Pump Refills in Children

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrathecal pump refill with Virtual Reality

Other

VR game

Intrathecal pump refill with distraction

Other

Video

Intrathecal pump refill

Other

daily routine care for pump refill

Primary outcomes

  1. 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

  1. Procedural pain

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

    Procedural pain during refill is assessed with the Face, Legs, Activity, Cry, Consolability scale.

  2. Fear

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

    The degree of fear will be measured using the Child Fear Scale, based on reporting from the child and parent.

  3. Anxiety

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

    The Children's Anxiety Meter (CAM) will be used to measure anxiety. This scale will be filled in by children and parents.

  4. Statisfaction

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

    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.

  5. Adverse events

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

    The incidence of adverse events (nausea, vomiting, motion sickness, dizziness, seizure) will be evaluated after the refill with VR.

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Registry information

Official study title

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

Acronym: VAMPIRE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 4, 2021
Registry last updated
Mar 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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