Effect of the Format of a Video Game on Children's Experience During Venipuncture
Condition: Pain, Procedural
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      Anxiolysis and analgesia are of paramount importance when conducting medical procedures,
      particularly in children. Nonpharmacologic techniques such as distraction and hypnosis
      improve the patient experience when used in the correct setting and may reduce the need for
      medications and pharmacological sedation. Virtual reality immersion is a novel approach to
      anxiolysis and analgesia but the content (i.e. games) available on the market are limited in
      their appropriateness for age, and the lack of specific design for medical procedures.
      VRelief, designed using a multidisciplinary team of clinicians, hypnosis practitioners,
      psychologists and computer scientists specializing in the Multimodal Modelling of Emotion &
      Feeling may present a safe and superior alternative to a similar game presented in a video
      tablet format, in mitigating procedural anxiety and pain and improving the patient experience
      during venipuncture.
    

Detailed description: 
      Pain and anxiety experienced in the acute care setting remain a major global problem,
      resulting in high costs for those involved as well as for health care institutions. Pain and
      anxiety management techniques affect the quality of the care experienced by patients,
      relatives, and healthcare workers. Pharmacological procedures remain the most widely used
      approach, although they have important limitations, such as potential for adverse effects and
      dosing errors, especially in the most vulnerable populations such as young children.
      Non-pharmacological approaches to analgesia and anxiolysis have been explored, among which
      placebo, expectant, distraction, positive induction, reward, self-regulation, relaxation and
      hypnosis. Unfortunately, translational applications have been only partially successful, due
      to the limited and variable effectiveness of each approach, which often requires active and
      continuous patient cooperation. Hypnosis is an effective but incomplete approach that
      requires the presence of a specialist and can only be practiced from a certain age.

      Virtual Reality (VR) is a promising technology that combines all of these methods above into
      an immersive and engaging tool for pain and anxiety relief that could equal or exceed the
      effectiveness of other existing non-pharmacological techniques. In addition, it is relatively
      inexpensive and provides a relevant alternative when hypnosis practitioners are not
      available.

      The virtual reality contents (hereon ''games'') available on the market are varied. However,
      these tools are mainly based on distraction and often do not take into account the
      therapeutic communication and hypnosis principles proven useful in managing anxious children,
      as well as other psychological factors facilitating, for example, the "empowerment" of
      patients. Moreover, the quality of immersion in a virtual environment is essential for its
      effectiveness, and the tools currently available remain limited in this respect (mini-games,
      360-degree video). Moreover, these tools have little external control and even fewer
      intelligent mechanisms to adapt content to the patient experience.

      The investigators developed a prototype VR tool, which, unlike tools from other clinical
      studies of virtual reality, implemented a narration integrating several properties of
      hypnosis induction (in particular relaxation and regulation) with a gameplay designed to
      induce distraction and empowerment. The game was developed with the objective of engaging the
      child in an environment where he or she is first familiarized and reassured, then engaged in
      the missions of the game, and finally rewarded, all with the intent of decreasing anxiety and
      pain during a procedure. The investigators have carefully adapted the initial versions of
      this VR scenario to young, hospitalized children (starting from the age of 5 years of age)
      undergoing painful and anxiogenic procedures such as venipuncture. This population is ideal
      for our needs because they are often resistant to other non-pharmacological techniques
      (hypnosis susceptibility peaks between 8 and 12 years and, at the same time, have a good
      knowledge of artificial environments and computer games. A pilot study conducted in our
      department showed that children who played the VR game rated their pain and anxiety less high
      than children who received standard of care, during venipuncture. Venipuncture is some of the
      most common procedures in pediatric emergency departments and one of the most common sources
      of unrelieved pain and anxiety in hospitalized children.

      To date, no study has attempted to isolate the added value of VR by comparing it with a
      similar game offered in a format such as a video tablet (ie.g.: iPad, etc.).

      When used in a correct subset of patients (excluding patients with light-sensitive epilepsy),
      there are no risks anticipated aside from potential mild nausea or dizziness, which is rarely
      described in children using virtual reality, which would make this study a risk category A
      study.
    

Intervention name(s): Venipuncture
Intervention type(s): Diagnostic Test
Intervention description(s): Diagnostic venipuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypnosis; Virtual Reality; Behavioral intervention; Venipuncture