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Hematologic NeoplasmsPhase 2/3REVEHNCT03483194

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

A Phase 2/3 study testing Virtual Reality and Kalinox in people with Hematologic Neoplasms, run by Weprom at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Neoplasms
What is being tested?
Virtual Reality and Kalinox
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
5 sitesFrance
Study dates
6 Sep 2018to 19 Jun 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with malignant haematological pathology
  • Patient who must have an osteo-medullary biopsy for diagnostic purposes
  • Age ≥ 18 years
  • Performance Status < 3
  • Patient with no pelvic bone pain before inclusion
  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites
  • CHU Angers

    Angers, Pays de Loire, 49933

  • Institut Bergonié

    Bordeaux, Gironde, 33000

  • Centre Jean Bernard - Clinique Victor Hugo

    Le Mans, 72000

  • HIA Bégin

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

  • SOL Clinique Sainte-Anne

    Strasbourg, Alsace, 67000

Other trials in France

About this study

Official title: Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care

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.

Read the detailed description

Today, one third of the population suffers from anxiety and 20% of French people suffer from chronic pain. Many health situations or pathologies lead to difficult or painful care. The impact of drug solutions to relieve patients is often limited and more and more scientific studies are demonstrating the benefits of virtual reality to reduce pain, anxiety and addictions.

In 2011, following an experience of close to patient, a person created "l'Effet Papillon", a social enterprise that aims to create a concrete social impact in the lives of people with cancer, in situations of fragility or isolation and those who accompany them. Since 2011 the social enterprise has supported nearly 3,000 patients and today, the Butterfly Effect is a real partner of health actors by adopting a holistic approach to wellness in the face of disease and fragility.

Taking full advantage of the benefits of virtual reality that, used in medical settings, can reduce pain and anxiety, Bliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or or stress.

Bliss has been developed for and with patients in partnership with physicians, researchers and experts in virtual reality for therapeutic purposes.

Bliss offer a new tool for relaxation and well-being that relaxes and distracts users from moments of stress or anxiety.

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.

During the osteo-medullary biopsy the patient will lie on his stomach with his hands positioned under the head. This position is the one recommended by the French Society of Hematology for an osteo-medullary biopsy.

The osteo-medullary biopsy remains independent of the object of the study and will be carried out according to the national recommendations.

For patients randomized to the "Standard" arm, the treatment will be the same as that proposed outside the study (a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen + 1 bottle of xylocaine® 20 mL at the concentration of 10 mg / mL).

For randomized patients in the "Virtual Reality" arm, the VR session should begin 5 minutes before the start of the procedure (+ 1 bottle of Xylocaine® 20 mL at a concentration of 10 mg / mL). The VR session will last between 15 and 30 minutes depending on the speed programmed. The patient can continue the session if the gesture ends before the end of the virtual reality program.

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.

Being tested
Virtual Reality, Kalinox
Keywords
Therapeutic Virtual Reality, Pain related medical procedure management, Anxiety management, Osteo-medullary biopsy
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityDevice

    Also called Bliss

    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

  • KalinoxDrug

    Also called Control

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

Study groups in NCT03483194
Study groupRoleWhat they receive
Kalinox®Active comparatorThe 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®)
Receives: Drug: Kalinox
Virtual RealityExperimentalThe 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.
Receives: Device: Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of pain

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

    Measured: Fifteen minutes after the osteo-medullary biopsy

Secondary outcomes (11)
  1. Assessment of tolerance

    Quotation of nausea, dizziness or headache according to CTCAE

    Measured: During or within fifteen minutes after the osteo-medullary biopsy

  2. Assessment of the anxiety by specific questionnaire

    Anxiety will be evaluated by Inventory of situational anxiety and anxiety trait (IASTA scale)

    Measured: Fifteen minutes after the osteo-medullary biopsy

  3. Assessment of the anxiety by blood pressure measurement

    Anxiety will be evaluated by bood pressure measurement

    Measured: Fifteen minutes after the osteo-medullary biopsy

  4. Assessment of the fear of pain by questionnaire

    Fear of pain will be evaluated by a specific questionnaire

    Measured: Assessment at Baseline

  5. Assessment of the fear of pain by Visual Analog Scale

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

    Measured: Assessment at Baseline

  6. Assessment of residual pain

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

    Measured: One month after the osteo-medullary biopsy

  7. Assessment of investigator's satisfaction

    Satisfaction will be evaluated by a questionnaire for investigators

    Measured: Fifteen minutes after the osteo-medullary biopsy

  8. Assessment of patient's satisfaction

    Satisfaction will be evaluated by a questionnaire for patients

    Measured: Fifteen minutes after the osteo-medullary biopsy

  9. Assessment of nurse's satisfaction

    Satisfaction will be evaluated by a questionnaire for nurses

    Measured: Fifteen minutes after the osteo-medullary biopsy

  10. Assessment of drug consumption related to the osteo-medullary biopsy (Xylocaine)

    Drug consumption related to medical procedure will be evaluated by the number of bottle of xylocaine® (bottle of 20 mL, concentration of 10mg/mL) used

    Measured: During the osteo-medullary biopsy

  11. Assessment of drug consumption related to the osteo-medullary biopsy (Kalinox)

    Drug consumption related to medical procedure will be evaluated by the duration of exposure of a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen (time in minutes)

    Measured: During the osteo-medullary biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2018
  2. Study start6 Sep 2018
  3. Primary completion20 Apr 2020
  4. Study completion19 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03483194
Sponsor's protocol ID
WP-2017-01
Other IDs
2017-A02701-52
Acronym
REVEH
Status last verified
Jul 2019
First submitted
15 Mar 2018
Last updated
23 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36790852

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Virtual Reality and Kalinox in people with Hematologic Neoplasms, run by Weprom at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of pain (time frame: Fifteen minutes after the osteo-medullary biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03483194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.

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