Musculoskeletal CancersREVENRINCT03418597
Trial Evaluating Hypnosis Using Virtural Reality vs Standard Pain Management During Musculoskelettal Biopsy
A study testing Deep local anesthesia + Virtual reality and Deep local anesthesia alone in people with Musculoskeletal Cancers, run by Centre Leon Berard at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Cancers
- What is being tested?
- Deep local anesthesia + Virtual reality and Deep local anesthesia alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteFrance
- Study dates
- 31 Jan 2018to 16 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy
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
Read the 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.
- Conditions
- Musculoskeletal Cancers
- Being tested
- Deep local anesthesia + Virtual reality, Deep local anesthesia alone
- Keywords
- Virtual reality, Radio-guided biopsy, Pain, Anxiety, Patient's satisfaction
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep local anesthesia + Virtual realityProcedure or surgery
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.
Deep local anesthesia aloneProcedure or surgery
Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne).
| Study group | Role | What they receive |
|---|---|---|
| Deep local anesthesia + Virtual reality | Experimental | 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 . Receives: Procedure: Deep local anesthesia + Virtual reality |
| Deep local anesthesia alone | Active comparator | The musculoskeletal biopsy is performed according to the standard practice using a deep local anesthesia with premedication and lidocaïne. Receives: Procedure: Deep local anesthesia alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 0
Secondary outcomes (5)
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 "
Measured: 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 "
Measured: 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
Measured: 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 ".
Measured: Day 0
Evaluate costs in both arms
Evaluation of costs involved for the patient's treatment and care
Measured: through study completion, an average of 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start31 Jan 2018
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal CancersStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOUHAMAMA Amine, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418597
- Sponsor's protocol ID
- ET17-066 (REVENRI)
- Acronym
- REVENRI
- Status last verified
- Aug 2018
- First submitted
- 5 Jan 2018
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy
- ClinicalTrials.gov ID
- NCT03418597
- Acronym / sponsor ID
- REVENRI / ET17-066 (REVENRI)
- Conditions
- Musculoskeletal Cancers
- Keywords
- Virtual reality, Radio-guided biopsy, Pain, Anxiety, Patient's satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep local anesthesia + Virtual reality | Experimental | Procedure: Deep local anesthesia + Virtual realityPre-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 . |
| Deep local anesthesia alone | Active comparator | Procedure: Deep local anesthesia aloneThe musculoskeletal biopsy is performed according to the standard practice using a deep local anesthesia with premedication and lidocaïne. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep local anesthesia + Virtual realityBiopsy 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. | Procedure or surgery | Deep local anesthesia + Virtual reality |
| Deep local anesthesia aloneBiopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne). | Procedure or surgery | Deep local anesthesia alone |
Primary outcome
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)
5 secondary outcomes
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
Evaluate in both arms, the anxiety linked to the biopsy procedure using a numeric scale graduated from 0 to 10
Time frame: Day 0
Evaluate the analgesics consumption in both arms
Time frame: through study completion, an average of 24 hours
Evaluate the global satisfaction of patients in both arms
Time frame: Day 0
Evaluate costs in both arms
Time frame: through study completion, an average of 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BOUHAMAMA Amine, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep local anesthesia + Virtual reality and Deep local anesthesia alone in people with Musculoskeletal Cancers, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy. (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.