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

• ClinicalTrials.gov Identifier: NCT03418597
• Recruitment Status: Completed
• First Posted: February 1, 2018
• Last Update Posted: August 23, 2018
• Sponsor: Centre Leon Berard
• Information provided by (Responsible Party): Centre Leon Berard

Study Description

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

Condition or disease	Intervention/treatment	Phase
Musculoskeletal Cancers	Procedure: Deep local anesthesia + Virtual reality; Procedure: Deep local anesthesia alone	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy
• Actual Study Start Date: January 31, 2018
• Actual Primary Completion Date: May 16, 2018
• Actual Study Completion Date: May 16, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Deep local anesthesia + Virtual reality; 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 .	Procedure: Deep local anesthesia + Virtual reality; Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne). Patient will have a 3-D immersive experience, created using a visual and audio headset and a software labelled as medical device.
Active Comparator: Deep local anesthesia alone; The musculoskeletal biopsy is performed according to the standard practice using a deep local anesthesia with premedication and lidocaïne.	Procedure: Deep local anesthesia alone; Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne).

Outcome Measures

Primary Outcome Measures :

1. Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy. [ Time Frame: Day 0 ]
   The main outcome will be the pain level auto-evaluated by the patient using a numeric scale composed of 11 graduations (from 0 to 10)

Secondary Outcome Measures :

1. Evaluate in both arms, the pain linked to the biopsy procedure using a numeric scale graduated from 0 to 10. [ Time Frame: Day 1 (+/-2h) post biopsy ]
   The score " 0 " corresponds to " No pain " and the score " 10 " corresponds to " Maximum amount of imaginable pain "
2. Evaluate in both arms, the anxiety linked to the biopsy procedure using a numeric scale graduated from 0 to 10 [ Time Frame: Day 0 ]
   The score " 0 " corresponds to " No anxiety " and the score " 10 " corresponds to " Maximum imaginable anxiety "
3. Evaluate the analgesics consumption in both arms [ Time Frame: through study completion, an average of 24 hours ]
   Evaluation according to the following classification and recording the dosages and units taken: Level 1 - Non morphinic analgesics; Level 2 - Weak opioides analgesics; Level 3 - Strong opioides analgesic
4. Evaluate the global satisfaction of patients in both arms [ Time Frame: Day 0 ]
   The score "0" corresponds to " Absence of satisfaction " and the score " 10 " corresponds to " Full satisfaction ".
5. Evaluate costs in both arms [ Time Frame: through study completion, an average of 24 hours ]
   Evaluation of costs involved for the patient's treatment and care

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

France

Centre Leon Berard

Lyon, France, 69008

Sponsors and Collaborators

Centre Leon Berard

Investigators

• Principal Investigator: BOUHAMAMA Amine, MD; Centre Leon Berard

More Information

• Responsible Party: Centre Leon Berard
• ClinicalTrials.gov Identifier: NCT03418597
• Other Study ID Numbers: ET17-066 (REVENRI)
• First Posted: February 1, 2018
• Last Update Posted: August 23, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Leon Berard:

Virtual reality; Radio-guided biopsy; Pain; Anxiety; Patient's satisfaction

Additional relevant MeSH terms:

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs