Clinical trial NCT03418597: Trial Evaluating Hypnosis Using Virtural Reality vs Standard Pain Management During Musculoskelettal Biopsy
Official title: Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Cancers
Keywords: Virtual reality
Radio-guided biopsy
Pain
Anxiety
Patient's satisfaction
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy.
timeFrame: Day 0
Secondary outcomes:
measure: Evaluate in both arms, the pain linked to the biopsy procedure using a numeric scale graduated from 0 to 10.
timeFrame: Day 1 (+/-2h) post biopsy
measure: Evaluate in both arms, the anxiety linked to the biopsy procedure using a numeric scale graduated from 0 to 10
timeFrame: Day 0
measure: Evaluate the analgesics consumption in both arms
timeFrame: through study completion, an average of 24 hours
measure: Evaluate the global satisfaction of patients in both arms
timeFrame: Day 0
measure: Evaluate costs in both arms
timeFrame: through study completion, an average of 24 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Leon Berard
Study officials:
affiliation: Centre Leon Berard
name: BOUHAMAMA Amine, MD
role: PRINCIPAL_INVESTIGATOR
References: