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Clinical Trials/NCT03888690
NCT03888690
Unknown
N/A

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.

Central Hospital, Nancy, France1 site in 1 country96 target enrollmentApril 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Procedural Pain
Sponsor
Central Hospital, Nancy, France
Enrollment
96
Locations
1
Primary Endpoint
Pain scores
Last Updated
7 years ago

Overview

Brief Summary

  • 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

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
June 30, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria

  • Serious behavioral disorders
  • Serious neurosensory deficit

Outcomes

Primary Outcomes

Pain scores

Time Frame: 1 hour

Analogical visual scale

Secondary Outcomes

  • Anxiety scores(1 hour)
  • Traceability of the procedure(12 months)

Study Sites (1)

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