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

Primary Purpose

Procedural Pain, Procedural Anxiety, Virtual Reality

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual Reality Headset
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Procedural Pain focused on measuring Children, Adolescent, non pharmacological interventions, onco-hematologic

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria:

  • Serious behavioral disorders
  • Serious neurosensory deficit

Sites / Locations

  • Chru Nancy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

With and then without VR

Without and then with VR

Arm Description

Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR.

Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention.

Outcomes

Primary Outcome Measures

Pain scores
Analogical visual scale

Secondary Outcome Measures

Anxiety scores
Yale scale
Traceability of the procedure
Pain management scorecard

Full Information

First Posted
March 18, 2019
Last Updated
March 21, 2019
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT03888690
Brief Title
Effect of Virtual Reality Distraction on Procedural Pain for Children and Adolescents in Onco-Hematology Unit.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain, Procedural Anxiety, Virtual Reality
Keywords
Children, Adolescent, non pharmacological interventions, onco-hematologic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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").
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
With and then without VR
Arm Type
Active Comparator
Arm Description
Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR.
Arm Title
Without and then with VR
Arm Type
Active Comparator
Arm Description
Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention.
Intervention Type
Device
Intervention Name(s)
Virtual Reality Headset
Intervention Description
Standardized procedures, with or without Virtual Reality Headset.
Primary Outcome Measure Information:
Title
Pain scores
Description
Analogical visual scale
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Anxiety scores
Description
Yale scale
Time Frame
1 hour
Title
Traceability of the procedure
Description
Pain management scorecard
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children or Adolescent supported in onco-hematologic unit. Exclusion Criteria: Serious behavioral disorders Serious neurosensory deficit
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle PEROT
Phone
03-83-15-46-31
Email
isaperot@orange.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène PETIT
Phone
03-83-15-46-31
Email
mh.petit@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludovic MANSUY
Organizational Affiliation
CHRU NANCY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chru Nancy
City
Vandœuvre-lès-Nancy
State/Province
Lorraine
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26476281
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.
Results Reference
background
PubMed Identifier
26755209
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.
Results Reference
result
PubMed Identifier
27409593
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.
Results Reference
result
PubMed Identifier
27112434
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.
Results Reference
result

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

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