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

March 21, 2019 updated by: Central Hospital, Nancy, France

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.

  • 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Lorraine
      • Vandœuvre-lès-Nancy, Lorraine, France, 54500
        • CHRU Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children or Adolescent supported in onco-hematologic unit.

Exclusion Criteria:

  • Serious behavioral disorders
  • Serious neurosensory deficit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With and then without VR
Virtual Reality with standardized procedures for first intervention, Standardized procedures for second intervention, without VR.
Device: Virtual Reality Headset
Standardized procedures, with or without Virtual Reality Headset.
Active Comparator: Without and then with VR
Standardized procedures without VR for first intervention, Virtual Reality with standardized procedures for second intervention.
Device: Virtual Reality Headset
Standardized procedures, with or without Virtual Reality Headset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: 1 hour
Analogical visual scale
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety scores
Time Frame: 1 hour
Yale scale
1 hour
Traceability of the procedure
Time Frame: 12 months
Pain management scorecard
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Ludovic MANSUY, CHRU Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRU NANCY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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