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

NCT ID: NCT03888690

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-06-30

Brief Summary

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* 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

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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.

Conditions

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Procedural Pain Procedural Anxiety Virtual Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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With and then without VR

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

Group Type ACTIVE_COMPARATOR

Virtual Reality Headset

Intervention Type DEVICE

Standardized procedures, with or without Virtual Reality Headset.

Without and then with VR

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

Group Type ACTIVE_COMPARATOR

Virtual Reality Headset

Intervention Type DEVICE

Standardized procedures, with or without Virtual Reality Headset.

Interventions

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Virtual Reality Headset

Standardized procedures, with or without Virtual Reality Headset.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria

* Serious behavioral disorders
* Serious neurosensory deficit
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ludovic MANSUY

Role: PRINCIPAL_INVESTIGATOR

CHRU NANCY

Locations

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Chru Nancy

Vandœuvre-lès-Nancy, Lorraine, France

Site Status

Countries

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France

Central Contacts

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Isabelle PEROT

Role: CONTACT

03-83-15-46-31

Marie-Hélène PETIT

Role: CONTACT

03-83-15-46-31

References

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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.

Reference Type BACKGROUND
PMID: 26476281 (View on PubMed)

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.

Reference Type RESULT
PMID: 26755209 (View on PubMed)

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.

Reference Type RESULT
PMID: 27409593 (View on PubMed)

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.

Reference Type RESULT
PMID: 27112434 (View on PubMed)

Other Identifiers

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CHRU NANCY

Identifier Type: -

Identifier Source: org_study_id

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