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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03888690
Acronym
ReVaDo
Enrollment
96
Registered
2019-03-25
Start date
2019-04-01
Completion date
2020-06-30
Last updated
2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Procedural Anxiety, Procedural Pain, Virtual Reality

Keywords

Children, Adolescent, non pharmacological interventions, onco-hematologic

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.

Interventions

DEVICEVirtual Reality Headset

Standardized procedures, with or without Virtual Reality Headset.

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Children or Adolescent supported in onco-hematologic unit.

Exclusion criteria

* Serious behavioral disorders * Serious neurosensory deficit

Design outcomes

Primary

MeasureTime frameDescription
Pain scores1 hourAnalogical visual scale

Secondary

MeasureTime frameDescription
Anxiety scores1 hourYale scale
Traceability of the procedure12 monthsPain management scorecard

Countries

France

Contacts

Primary ContactIsabelle PEROT
isaperot@orange.fr03-83-15-46-31
Backup ContactMarie-Hélène PETIT
mh.petit@chru-nancy.fr03-83-15-46-31

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026