An interventional study of Deep local anesthesia + Virtual reality and Deep local anesthesia alone in Musculoskeletal Cancers, sponsored by Centre Leon Berard. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-23.
Sponsored by Centre Leon Berard · Not applicable, Interventional, and Treatment
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Among 482 studies in Pain with a site in France — 75 open to participants now, 79 under way, 8 of them phase 3. Pain · France.
Among the 482 studies in Pain with a site in France, this one is the 157th largest by enrollment of the 369 interventional ones that give a count, is one of 22 that started in 2018, is one of 225 with no phase, and was the 253rd registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →75 of the 482 studies in Pain with a site in France are open now. Recruiting first, the newest first:
University Hospital, Angers · Sites in France
Ages 18–120
Farraj Miguel · Sites in France, Belgium
Ages 18+
University Hospital, Toulouse · Sites in France
Ages 18+
University Hospital, Limoges · Sites in France
Ages 18–50 · Women only
Teleflex · Sites in France, United States, Latvia and 1 more country
Ages 18–80
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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482 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 33 · Phase 3 83 · Phase 4 29
First in 2000; this study’s year is marked. 22 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 99 is above the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 80 across the 369 interventional studies, 100 across the 112 observational. Of the 348 that completed or were terminated, 31 (9%) have results posted.
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68 of 482 have an industry lead sponsor. The 10 most frequent:
Centre Leon Berard is the lead sponsor of 210 studies on the registry; 62 are open to participants now.
Centre Leon Berard has 3 studies filed under Pain — fewer than ten, so there is no comparison to draw.
25 of the studies in Pain with a site in France that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06381063Phase 3Centre Hospitalier Universitaire, AmiensNon-steroidal Anti-inflammatory in Cardiac Surgery | 2027-03 |
| NCT06917651Phase 3University Hospital, Clermont-FerrandManagement of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation. | 2027-04-22 |
| NCT05275881Poitiers University HospitalImpact of Virtual Reality in Hematology and Oncology During Invasive Procedures in Children, Adolescents and Young Adults, from 7 to Less Than 25 Years Old | 2026-11-13 |
| NCT07668050University Hospital, Clermont-FerrandA Study of the Impact of a Virtual Reality Medical Device (HypnoVR® Headset) on Anxiety and Pain in Interventional Radiology. | 2026-12 |
| NCT06779812Clinique BizetImpact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC | 2026-12 |
Add all 25 to your calendar (.ics) → With an account.
Among the 482 studies in Pain with a site in France, from their registry updates:
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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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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). 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).
Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy.
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 0
Evaluate in both arms, the pain linked to the biopsy procedure using a numeric scale graduated from 0 to 10.
The score " 0 " corresponds to " No pain " and the score " 10 " corresponds to " Maximum amount of imaginable pain "
Time frame: Day 1 (+/-2h) post biopsy
Evaluate in both arms, the anxiety linked to the biopsy procedure using a numeric scale graduated from 0 to 10
The score " 0 " corresponds to " No anxiety " and the score " 10 " corresponds to " Maximum imaginable anxiety "
Time frame: Day 0
Evaluate the analgesics consumption in both arms
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: through study completion, an average of 24 hours
Evaluate the global satisfaction of patients in both arms
The score "0" corresponds to " Absence of satisfaction " and the score " 10 " corresponds to " Full satisfaction ".
Time frame: Day 0
Evaluate costs in both arms
Evaluation of costs involved for the patient's treatment and care
Time frame: through study completion, an average of 24 hours
Ran from Jan 2018 to primary completion in May 2018, 3 months.
Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's 3 months is below that.
Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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