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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483194
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
L'effet Papillon
Information provided by (Responsible Party):
Weprom

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.


Condition or disease Intervention/treatment Phase
Hematologic Neoplasms Device: Virtual Reality Drug: Kalinox Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care
Actual Study Start Date : September 6, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: Kalinox®
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
Usually take care of by a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen for the medical procedure (osteo-medullary biopsy)
Other Name: Control

Experimental: Virtual Reality
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
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
Other Name: Bliss




Primary Outcome Measures :
  1. Assessment of pain [ Time Frame: Fifteen minutes after the osteo-medullary biopsy ]
    Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain).


Secondary Outcome Measures :
  1. Assessment of tolerance [ Time Frame: During or within fifteen minutes after the osteo-medullary biopsy ]
    Quotation of nausea, dizziness or headache according to CTCAE

  2. Assessment of the anxiety by specific questionnaire [ Time Frame: Fifteen minutes after the osteo-medullary biopsy ]
    Anxiety will be evaluated by Inventory of situational anxiety and anxiety trait (IASTA scale)

  3. Assessment of the anxiety by blood pressure measurement [ Time Frame: Fifteen minutes after the osteo-medullary biopsy ]
    Anxiety will be evaluated by bood pressure measurement

  4. Assessment of the fear of pain by questionnaire [ Time Frame: Assessment at Baseline ]
    Fear of pain will be evaluated by a specific questionnaire

  5. Assessment of the fear of pain by Visual Analog Scale [ Time Frame: Assessment at Baseline ]
    Fear of pain will be evaluated by a Visual Analog Scale (0 = no pain at 10 = worst possible pain).

  6. Assessment of residual pain [ Time Frame: One month after the osteo-medullary biopsy ]
    Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain).

  7. Assessment of investigator's satisfaction [ Time Frame: Fifteen minutes after the osteo-medullary biopsy ]
    Satisfaction will be evaluated by a questionnaire for investigators

  8. Assessment of patient's satisfaction [ Time Frame: Fifteen minutes after the osteo-medullary biopsy ]
    Satisfaction will be evaluated by a questionnaire for patients

  9. Assessment of nurse's satisfaction [ Time Frame: Fifteen minutes after the osteo-medullary biopsy ]
    Satisfaction will be evaluated by a questionnaire for nurses

  10. Assessment of drug consumption related to the osteo-medullary biopsy (Xylocaine) [ Time Frame: During the osteo-medullary biopsy ]
    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

  11. Assessment of drug consumption related to the osteo-medullary biopsy (Kalinox) [ Time Frame: During the osteo-medullary biopsy ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with malignant haematological pathology
  2. Patient who must have an osteo-medullary biopsy for diagnostic purposes
  3. Age ≥ 18 years
  4. Performance Status < 3
  5. Patient with no pelvic bone pain before inclusion
  6. Patient with normal coagulation balance (TP, Activated Partial Thromboplastin Time, fibrin) and platelet count> 50 G / L
  7. Patient affiliated to the social security scheme
  8. Patient giving written consent before any specific procedure related to the study

Exclusion Criteria:

  1. Patient regularly taking antalgic treatments from stage 2 or 3
  2. Patient with congenital coagulation disorder or acquired or taking anticoagulant therapy such as: fluindione, acenocoumarol, warfarin, dabigatran, apixaban or rivaroxaban
  3. 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
  4. Any contraindication to the use of the headset: pacemaker or other implanted medical device
  5. Pregnancy or breastfeeding
  6. Persons deprived of liberty, under guardianship or under guardianship
  7. Dementia, mental impairment or psychiatric condition that may compromise patient informed consent and / or protocol compliance and follow-up of the trial
  8. Patient unable to undergo protocol monitoring for psychological, social, family or geographical reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483194


Contacts
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Contact: Magali BALAVOINE 2 41 68 29 40 ext +33 m.balavoine@weprom.fr

Locations
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France
SOL Clinique Sainte-Anne Recruiting
Strasbourg, Alsace, France, 67000
Contact: MALOISEL Frédéric, MD         
Contact: SALER Christine         
Principal Investigator: MALOISEL Frédéric, MD         
Institut Bergonié Active, not recruiting
Bordeaux, Gironde, France, 33000
HIA Bégin Recruiting
Saint-Mandé, Ile De France, France, 94160
Contact: VANQUAETHEM Hélène, MD         
Contact: LEITERER Caroline         
Principal Investigator: VANQUAETHEM Hélène, MD         
CHU Angers Active, not recruiting
Angers, Pays De Loire, France, 49933
Centre Jean Bernard - Clinique Victor Hugo Recruiting
Le Mans, France, 72000
Contact: Katell LE DU, MD       k.ledu@cjb72.org   
Principal Investigator: Katell LE DU, MD         
Sponsors and Collaborators
Weprom
L'effet Papillon
Investigators
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Principal Investigator: Katell LE DU, MD Centre Jean Bernard - Le Mans

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Responsible Party: Weprom
ClinicalTrials.gov Identifier: NCT03483194    
Other Study ID Numbers: WP-2017-01
2017-A02701-52 ( Other Identifier: French Health Products Safety Agency )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weprom:
Therapeutic Virtual Reality
Pain related medical procedure management
Anxiety management
Osteo-medullary biopsy
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Hematologic Diseases
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents