Clinical trial · Interventional
Trial Evaluating Hypnosis Using Virtural Reality vs Standard Pain Management During Musculoskelettal Biopsy
Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy
NCT03418597CI-TRIAL-00034528REVENRIcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 primary objective of this trial is to evaluate the benefit of the virtual reality technology in the pain management for patients having a radio-guided musculoskeletal biopsy indication
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 |
|---|---|---|---|
| Musculoskeletal Cancers | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep local anesthesia alone | Procedure | — | UNRESOLVED |
| Deep local anesthesia + Virtual reality | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Deep local anesthesia + Virtual reality
- description
- Pre-medication procedures and lidocaïne injection are the same as in the current practice. During the intervention delay, the patient will also experience hypnosis through a virtual reality procedure .
- interventionNames
- Procedure: Deep local anesthesia + Virtual reality
- type
- ACTIVE_COMPARATOR
- label
- Deep local anesthesia alone
- description
- The musculoskeletal biopsy is performed according to the standard practice using a deep local anesthesia with premedication and lidocaïne.
- interventionNames
- Procedure: Deep local anesthesia alone
Primary outcomes (1)
- measure
- Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Man or woman, aged \>= 18 years at the day of consenting to the study (no upper limit) * Requiring a radio-guided biopsy of the musculoskeletal system, * Informed and signed consent, * Patient covered by a medical insurance. Exclusion Criteria: * Deaf patient; * Visually-impaired patient; * Claustrophobic and/or aquaphobic patient; * Contraindication to a musculoskeletal biopsy, including to the premedication protocol and to the lidocaine; * Person deprived of liberty or placed under guardianship; * Absence of French language skills; * History of psychiatric disease such as paranoia, schizophrenia, manic-depressive psychosis, patient with a high risk of suicide.
References
Publications (0)
Data not yet available
No reference posted for this study.