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

Virtual Reality Clinical Trial

— ReVaDo  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03888690
• Other study ID #: CHRU NANCY
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2019
• Source: Central Hospital, Nancy, France
• Contact: Isabelle PEROT
• Phone: 03-83-15-46-31
• Email: isaperot[@]orange.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 30, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria:

• Serious behavioral disorders

• Serious neurosensory deficit

Related Conditions & MeSH terms

• Pain, Procedural
• Procedural Anxiety
• Procedural Pain
• Virtual Reality

Intervention

Device:
• Virtual Reality Headset
Standardized procedures, with or without Virtual Reality Headset.

Locations

Country	Name	City	State
France	Chru Nancy	Vandœuvre-lès-Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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 — View Citation

Aydin D, Sahiner NC, Çiftçi 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/j — View 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. Review. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	Analogical visual scale	1 hour
Secondary	Anxiety scores	Yale scale	1 hour
Secondary	Traceability of the procedure	Pain management scorecard	12 months