Status:
COMPLETED
Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care (REVEH)
Lead Sponsor:
Weprom
Collaborating Sponsors:
L'effet Papillon
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 emis...
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03483194
Start Date
September 6 2018
End Date
June 19 2020
Last Update
June 23 2020
Active Locations (5)
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1
SOL Clinique Sainte-Anne
Strasbourg, Alsace, France, 67000
2
Institut Bergonié
Bordeaux, Gironde, France, 33000
3
CHU Angers
Angers, Pays de Loire, France, 49933
4
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, France, 72000