Clinical trial · Interventional
Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care (REVEH)
Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Kalinox | Drug | — | UNRESOLVED |
| Virtual Reality | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Kalinox®
- description
- 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®)
- interventionNames
- Drug: Kalinox
- type
- EXPERIMENTAL
- label
- Virtual Reality
- description
- 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.
- interventionNames
- Device: Virtual Reality
Primary outcomes (1)
- measure
- Assessment of pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLe 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. PMID 36790852