Effect of Virtual Reality Distraction on Procedural Pain for Children and Adolescents in Onco-Hematology Unit.

Study Overview
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Brief Summary
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Demonstrate the effectiveness of the Virtual Reality (VR) distraction on pain reduction in children and adolescents in onco-hematology unit compared to standard practice. Evaluate the impact of VR on the level of anxiety induced by invasive procedures Report traceability of assessment of pain and anxiety scores, and reproducibility of procedural analgesia techniques. Evaluate the impact of VR on the short-term consequences of procedural pain, especially in terms of phobia of care.

Detailed Description
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Diagnosis and therapeutic management of onco-hematological pathologies in children and adolescents require multiple invasive procedures that cause pain and discomfort. These are paramedical procedures (blood sampling on the peripheral vein, placement of infusions, placement of Hubert's needles on an implantable device, ...) and medical procedures (lumbar punctures, medullary punctures, ...). The short-term (phobia of care) and long-term consequences (memory of pain, behavioral disorders, nociceptive sensitization) are clearly reported in the medical literature, and the importance of thinking about pharmacological and non-pharmacological techniques well-established procedural pain prevention. The quality of the management of the pain and anxiety induced by these invasive oprocedures in pediatric onco-hematology conditions the adhesion to the care and the treatments, and thus constitutes a challenge in the care of the patients. The non-pharmacological methods are numerous and still insufficiently used by the care teams. Virtual Reality is on interesting option.

Official Title
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Randomized Controlled Trial Evaluating the Effectiveness of the Virtual Reality Distraction Compared to Current Practice, on Reducing Procedural Pain in Children and Adolescents Supported in Pediatric Onco-Hematology Unit.

Conditions
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Procedural Pain, Procedural Anxiety, Virtual Reality

Intervention / Treatment
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* Device: Virtual Reality Headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children or Adolescent supported in onco-hematologic unit. Exclusion Criteria: Serious behavioral disorders Serious neurosensory deficit

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Interventional monocentric regional study opened in crossover test with randomization of sequence (sequence 1 with then without Virtual Reality, sequence 2 without then with Virtual reality).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: With and then without VR<br>Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR. | Device: Virtual Reality Headset<br>* Standardized procedures, with or without Virtual Reality Headset.<br>|
| Active Comparator: Without and then with VR<br>Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention. | Device: Virtual Reality Headset<br>* Standardized procedures, with or without Virtual Reality Headset.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Analogical visual scale | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety scores | Yale scale | 1 hour | 
| Traceability of the procedure | Pain management scorecard | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Adolescent, non pharmacological interventions, onco-hematologic