Trial Evaluating Hypnosis Using Virtural Reality vs Standard Pain Management During Musculoskelettal Biopsy (REVENRI)

Léon Bérard Center

Status: Completed

Conditions: Musculoskeletal Cancers

Treatments: Procedure: Deep local anesthesia alone; Procedure: Deep local anesthesia + Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT03418597

ET17-066 (REVENRI)

Details and patient eligibility

About

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

Full description

During the last years, the percutaneous biopsies took a growing importance in the diagnosis of musculoskeletal cancers. The most important advantages of percutaneous biopsies are: 1) Often performed under local anesthesia in out-patient department, 2) No visible scars, 3) Surgical intervention avoided in case of benign tumor with a low level of complications (infection, hematoma, pain).

The technology improvement of percutaneous biopsy leads to a high diagnosis success rate (80.8% for bone tumors and 83.2% for soft tissues tumors') with a low complication rate (0.7%) and then justifies the use of percutaneous biopsy as first-line diagnostic exam.

During a percutaneous biopsy, the pain is frequently felt with an increase in the "pain numeric scale" evaluated after the procedure.

The nitrous oxide is a gas mixture which can be used for its anesthetic and antalgic properties, making the pain tolerable for the patients during short procedures. However, it can cause adverse events such as nausea, vomiting and nervous system affections (excessive sedation, anxiety). Moreover, this gas is not always efficient for the pain management.

Other options have been investigated such as hypnosis and music therapy which improve patients' experience of the medical interventional procedures.

The virtual reality is a digital tool existing for about 10 years. It enables to isolate a patient from the real world which can be useful in some medical indications. It is a 3-D immersive experience, created using a visual and audio headset. Virtual reality can reduce the pain experienced during surgical interventions and has widely shown its interest in algogenic cares.

While the results are promising, a recent review of the literature shows that very few randomized clinical trials document the virtual reality benefit in pain and/or anxiety management for burn patients or patients suffering from acute or chronic pains.

The objective of this study is to demonstrate the benefit of the virtual reality in addition to a deep local anesthesia vs a deep local anesthesia alone in the pain management linked to musculoskeletal tumors biopsy.

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 2 patient groups

Deep local anesthesia + Virtual reality

Experimental group

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 .

Treatment:

Procedure: Deep local anesthesia + Virtual reality

Deep local anesthesia alone

Active Comparator group

Description:

The musculoskeletal biopsy is performed according to the standard practice using a deep local anesthesia with premedication and lidocaïne.

Treatment:

Procedure: Deep local anesthesia alone