Centre Leon Berard
Lyon, 69008, France
NCT Number: NCT03418597
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Lyon, 69008, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne).
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)
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 "
Time frame: Day 0
The score " 0 " corresponds to " No anxiety " and the score " 10 " corresponds to " Maximum imaginable anxiety "
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
Time frame: Day 0
The score "0" corresponds to " Absence of satisfaction " and the score " 10 " corresponds to " Full satisfaction ".
Time frame: through study completion, an average of 24 hours
Evaluation of costs involved for the patient's treatment and care
Centre Leon Berard
Other
Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy
Acronym: REVENRI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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