Clinical trial NCT03888690: Effect of Virtual Reality Distraction on Procedural Pain for Children and Adolescents in Onco-Hematology Unit.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Pain
Procedural Anxiety
Virtual Reality
Keywords: Children
Adolescent
non pharmacological interventions
onco-hematologic
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 96
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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").
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria:

* Serious behavioral disorders
* Serious neurosensory deficit

Primary outcomes:
measure: Pain scores
timeFrame: 1 hour
Secondary outcomes:
measure: Anxiety scores
timeFrame: 1 hour
measure: Traceability of the procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Chru Nancy
state: Lorraine
Study officials:
affiliation: CHRU NANCY
name: Ludovic MANSUY
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.