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

Central Hospital, Nancy, France

Status: Unknown

Conditions: Procedural Anxiety; Virtual Reality; Procedural Pain

Treatments: Device: Virtual Reality Headset

Study type: Interventional

Funder types: Other

Identifiers

NCT03888690

CHRU NANCY

Details and patient eligibility

About

• 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.

Full description

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children or Adolescent supported in onco-hematologic unit.

Exclusion criteria

• Serious behavioral disorders
• Serious neurosensory deficit

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

With and then without VR

Active Comparator group

Description:

Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR.

Treatment:

Device: Virtual Reality Headset

Without and then with VR

Active Comparator group

Description:

Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention.

Treatment:

Device: Virtual Reality Headset