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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With and then without VR | Active Comparator | Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR. |
|
| Without and then with VR | Active Comparator | Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Headset | Device | Standardized procedures, with or without Virtual Reality Headset. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Analogical visual scale | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety scores | Yale scale | 1 hour |
| Traceability of the procedure | Pain management scorecard | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle PEROT | Contact | 03-83-15-46-31 | isaperot@orange.fr | |
| Marie-Hélène PETIT | Contact | 03-83-15-46-31 | mh.petit@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Ludovic MANSUY | CHRU NANCY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chru Nancy | Vandœuvre-lès-Nancy | Lorraine | 54500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26476281 | Background | Chow CH, Van Lieshout RJ, Schmidt LA, Dobson KG, Buckley N. Systematic Review: Audiovisual Interventions for Reducing Preoperative Anxiety in Children Undergoing Elective Surgery. J Pediatr Psychol. 2016 Mar;41(2):182-203. doi: 10.1093/jpepsy/jsv094. Epub 2015 Oct 17. | |
| 26755209 | Result | Felluga M, Rabach I, Minute M, Montico M, Giorgi R, Lonciari I, Taddio A, Barbi E. A quasi randomized-controlled trial to evaluate the effectiveness of clowntherapy on children's anxiety and pain levels in emergency department. Eur J Pediatr. 2016 May;175(5):645-50. doi: 10.1007/s00431-015-2688-0. Epub 2016 Jan 12. |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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").
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| 27409593 | Result | Al-Khotani A, Bello LA, Christidis N. Effects of audiovisual distraction on children's behaviour during dental treatment: a randomized controlled clinical trial. Acta Odontol Scand. 2016 Aug;74(6):494-501. doi: 10.1080/00016357.2016.1206211. Epub 2016 Jul 13. |
| 27112434 | Result | Aydin D, Sahiner NC, Ciftci EK. Comparison of the effectiveness of three different methods in decreasing pain during venipuncture in children: ball squeezing, balloon inflating and distraction cards. J Clin Nurs. 2016 Aug;25(15-16):2328-35. doi: 10.1111/jocn.13321. Epub 2016 Apr 26. |