Hematologic Neoplasms Clinical Trial
— REVEHOfficial title:
Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care
Verified date | July 2019 |
Source | Weprom |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 126 |
Est. completion date | June 19, 2020 |
Est. primary completion date | April 20, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Angers | Angers | Pays De Loire |
France | Institut Bergonié | Bordeaux | Gironde |
France | Centre Jean Bernard - Clinique Victor Hugo | Le Mans | |
France | HIA Bégin | Saint-Mandé | Ile De France |
France | SOL Clinique Sainte-Anne | Strasbourg | Alsace |
Lead Sponsor | Collaborator |
---|---|
Weprom | L'effet Papillon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Assessment of tolerance | Quotation of nausea, dizziness or headache according to CTCAE | During or within fifteen minutes after the osteo-medullary biopsy | |
Secondary | Assessment of the anxiety by specific questionnaire | Anxiety will be evaluated by Inventory of situational anxiety and anxiety trait (IASTA scale) | Fifteen minutes after the osteo-medullary biopsy | |
Secondary | Assessment of the anxiety by blood pressure measurement | Anxiety will be evaluated by bood pressure measurement | Fifteen minutes after the osteo-medullary biopsy | |
Secondary | Assessment of the fear of pain by questionnaire | Fear of pain will be evaluated by a specific questionnaire | Assessment at Baseline | |
Secondary | 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). | Assessment at Baseline | |
Secondary | Assessment of residual pain | Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain). | One month after the osteo-medullary biopsy | |
Secondary | Assessment of investigator's satisfaction | Satisfaction will be evaluated by a questionnaire for investigators | Fifteen minutes after the osteo-medullary biopsy | |
Secondary | Assessment of patient's satisfaction | Satisfaction will be evaluated by a questionnaire for patients | Fifteen minutes after the osteo-medullary biopsy | |
Secondary | Assessment of nurse's satisfaction | Satisfaction will be evaluated by a questionnaire for nurses | Fifteen minutes after the osteo-medullary biopsy | |
Secondary | 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 | During the osteo-medullary biopsy | |
Secondary | 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) | During the osteo-medullary biopsy |
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