NCT03888690

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

March 25, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

March 18, 2019

Last Update Submit

March 21, 2019

Conditions

Procedural PainProcedural AnxietyVirtual Reality

Keywords

ChildrenAdolescentnon pharmacological interventionsonco-hematologic

Outcome Measures

Primary Outcomes (1)

  • Pain scores

    Analogical visual scale

    1 hour

Secondary Outcomes (2)

  • Anxiety scores

    1 hour

  • Traceability of the procedure

    12 months

Study Arms (2)

With and then without VR

ACTIVE COMPARATOR

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

Device: Virtual Reality Headset

Without and then with VR

ACTIVE COMPARATOR

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

Device: Virtual Reality Headset

Interventions

Virtual Reality HeadsetDEVICE

Standardized procedures, with or without Virtual Reality Headset.

With and then without VRWithout and then with VR

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children or Adolescent supported in onco-hematologic unit.

You may not qualify if:

  • Serious behavioral disorders
  • Serious neurosensory deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, Lorraine, 54500, France

Location

Related Publications (4)

  • 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.

    PMID: 26476281BACKGROUND

  • 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.

    PMID: 26755209RESULT

  • 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.

    PMID: 27409593RESULT

  • 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.

    PMID: 27112434RESULT

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ludovic MANSUY

    CHRU NANCY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle PEROT

CONTACT

03-83-15-46-31isaperot@orange.fr

Marie-Hélène PETIT

CONTACT

03-83-15-46-31mh.petit@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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").
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 25, 2019

Study Start

April 1, 2019

Primary Completion

March 31, 2020

Study Completion

June 30, 2020

Last Updated

March 25, 2019

Record last verified: 2019-03

Locations

FR(1)