Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care (REVEH)

NCT03483194 | Completed Phase 2

• 2 other identifiers: WP-2017-012017-A02701-52
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

Brief Summary

The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment. However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment. Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness. The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.

Conditions

Hematologic Neoplasms

Keywords

Therapeutic Virtual Reality; Pain related medical procedure management; Anxiety management; Osteo-medullary biopsy

Outcome Measures

Primary Outcomes (1)

• Assessment of pain

  Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain).

  Fifteen minutes after the osteo-medullary biopsy

Secondary Outcomes (11)

• Assessment of tolerance

  During or within fifteen minutes after the osteo-medullary biopsy

• Assessment of the anxiety by specific questionnaire

  Fifteen minutes after the osteo-medullary biopsy

• Assessment of the anxiety by blood pressure measurement

  Fifteen minutes after the osteo-medullary biopsy

• Assessment of the fear of pain by questionnaire

  Assessment at Baseline

• Assessment of the fear of pain by Visual Analog Scale

  Assessment at Baseline

Study Arms (2)

Kalinox®

ACTIVE COMPARATOR

The included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen (Kalinox®)

Drug: Kalinox

Virtual Reality

EXPERIMENTAL

The included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a virtual reality (VR) session.

Device: Virtual Reality

Interventions

Virtual Reality DEVICE

Bliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or stress and / or during painful care here osteo-medullary biopsy

Also known as: Bliss

Virtual Reality

Kalinox DRUG

Usually take care of by a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen for the medical procedure (osteo-medullary biopsy)

Also known as: Control

Kalinox®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with malignant haematological pathology
• Patient who must have an osteo-medullary biopsy for diagnostic purposes
• Age ≥ 18 years
• Performance Status \< 3
• Patient with normal coagulation balance (TP, Activated Partial Thromboplastin Time, fibrin) and platelet count\> 50 G / L
• Patient affiliated to the social security scheme
• Patient giving written consent before any specific procedure related to the study

You may not qualify if:

• Patient regularly taking antalgic treatments from stage 2 or 3
• Patient with congenital coagulation disorder or acquired or taking anticoagulant therapy such as: fluindione, acenocoumarol, warfarin, dabigatran, apixaban or rivaroxaban
• Contraindication to a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen administration: true allergy, severe respiratory failure requiring continuous oxygen therapy, emphysema, pneumothorax, history of air embolism or diving accident, epilepsy or uncontrolled neurological disorder, unsubstituted vitamin deficiency B12 and folic acid, abdominal gas distension
• Any contraindication to the use of the headset: pacemaker or other implanted medical device
• Pregnancy or breastfeeding
• Persons deprived of liberty, under guardianship or under guardianship
• Dementia, mental impairment or psychiatric condition that may compromise patient informed consent and / or protocol compliance and follow-up of the trial
• Patient unable to undergo protocol monitoring for psychological, social, family or geographical reasons

Sponsors & Collaborators

• Weprom: lead
• L'effet Papillon: collaborator

Study Sites (5)

SOL Clinique Sainte-Anne

Strasbourg, Alsace, 67000, France

Location

Institut Bergonié

Bordeaux, Gironde, 33000, France

Location

CHU Angers

Angers, Pays de Loire, 49933, France

Location

Centre Jean Bernard - Clinique Victor Hugo

Le Mans, 72000, France

Location

HIA Bégin

Saint-Mandé, Île-de-France Region, 94160, France

Location

Related Publications (1)

• Le Du K, Septans AL, Maloisel F, Vanquaethem H, Schmitt A, Le Goff M, Clavert A, Zinger M, Bourgeois H, Dupuis O, Denis F, Bouchard S. A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study. J Med Internet Res. 2023 Feb 15;25:e38619. doi: 10.2196/38619.

  PMID: 36790852 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

kalinox

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Katell LE DU, MD

  Centre Jean Bernard - Le Mans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: March 30, 2018
• Study Start: September 6, 2018
• Primary Completion: April 20, 2020
• Study Completion: June 19, 2020
• Last Updated: June 23, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)