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

• Status: Completed
• Trial end date: 2020-06-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weprom
• Collaborator: L'effet Papillon

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