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

Not Applicable

• Conditions: Procedural Anxiety; Procedural Pain; Virtual Reality

• Registration Number: NCT03888690
• Lead Sponsor: Central Hospital, Nancy, France

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.

Study Timeline

• Status Verified: 2019-03
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-21
• Last Update Submitted: 2019-03-21
• Study First Posted: 2019-03-25
• Last Update Posted: 2019-03-25
• Study Start: 2019-04-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria

• Serious behavioral disorders
• Serious neurosensory deficit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain scores	1 hour	Analogical visual scale

Secondary Outcome Measures

Name	Time	Method
Anxiety scores	1 hour	Yale scale
Traceability of the procedure	12 months	Pain management scorecard

Trial Locations

Locations (1)

Chru Nancy; 🇫🇷 Vandœuvre-lès-Nancy, Lorraine, France