Hematologic NeoplasmsPhase 2/3REVEHNCT03483194
Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care (REVEH)
A Phase 2/3 study testing Virtual Reality and Kalinox in people with Hematologic Neoplasms, run by Weprom at 5 sites in France.
Trial summary
The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Virtual Reality and Kalinox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 5 sitesFrance
- Study dates
- 6 Sep 2018to 19 Jun 2020
- Phase
- Phase 2/3
- 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
- Patient with malignant haematological pathology
- Patient who must have an osteo-medullary biopsy for diagnostic purposes
- Age ≥ 18 years
- Performance Status < 3
- Patient with no pelvic bone pain before inclusion
- Patient with normal coagulation balance (TP, Activated Partial Thromboplastin Time, fibrin) and platelet count> 50 G / L
- Patient affiliated to the social security scheme
- Patient giving written consent before any specific procedure related to the study
Who cannot join
- Patient regularly taking antalgic treatments from stage 2 or 3
- Patient with congenital coagulation disorder or acquired or taking anticoagulant therapy such as: fluindione, acenocoumarol, warfarin, dabigatran, apixaban or rivaroxaban
- Contraindication to a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen administration: true allergy, severe respiratory failure requiring continuous oxygen therapy, emphysema, pneumothorax, history of air embolism or diving accident, epilepsy or uncontrolled neurological disorder, unsubstituted vitamin deficiency B12 and folic acid, abdominal gas distension
- Any contraindication to the use of the headset: pacemaker or other implanted medical device
- Pregnancy or breastfeeding
- Persons deprived of liberty, under guardianship or under guardianship
- Dementia, mental impairment or psychiatric condition that may compromise patient informed consent and / or protocol compliance and follow-up of the trial
- Patient unable to undergo protocol monitoring for psychological, social, family or geographical reasons
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Angers
Angers, Pays de Loire, 49933
Institut Bergonié
Bordeaux, Gironde, 33000
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000
HIA Bégin
Saint-Mandé, Île-de-France Region, 94160
SOL Clinique Sainte-Anne
Strasbourg, Alsace, 67000
About this study
Official title: Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care
The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment.
However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment.
Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness. The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.
Read the detailed description
Today, one third of the population suffers from anxiety and 20% of French people suffer from chronic pain. Many health situations or pathologies lead to difficult or painful care. The impact of drug solutions to relieve patients is often limited and more and more scientific studies are demonstrating the benefits of virtual reality to reduce pain, anxiety and addictions.
In 2011, following an experience of close to patient, a person created "l'Effet Papillon", a social enterprise that aims to create a concrete social impact in the lives of people with cancer, in situations of fragility or isolation and those who accompany them. Since 2011 the social enterprise has supported nearly 3,000 patients and today, the Butterfly Effect is a real partner of health actors by adopting a holistic approach to wellness in the face of disease and fragility.
Taking full advantage of the benefits of virtual reality that, used in medical settings, can reduce pain and anxiety, Bliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or or stress.
Bliss has been developed for and with patients in partnership with physicians, researchers and experts in virtual reality for therapeutic purposes.
Bliss offer a new tool for relaxation and well-being that relaxes and distracts users from moments of stress or anxiety.
The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment.
However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment. Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness.
During the osteo-medullary biopsy the patient will lie on his stomach with his hands positioned under the head. This position is the one recommended by the French Society of Hematology for an osteo-medullary biopsy.
The osteo-medullary biopsy remains independent of the object of the study and will be carried out according to the national recommendations.
For patients randomized to the "Standard" arm, the treatment will be the same as that proposed outside the study (a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen + 1 bottle of xylocaine® 20 mL at the concentration of 10 mg / mL).
For randomized patients in the "Virtual Reality" arm, the VR session should begin 5 minutes before the start of the procedure (+ 1 bottle of Xylocaine® 20 mL at a concentration of 10 mg / mL). The VR session will last between 15 and 30 minutes depending on the speed programmed. The patient can continue the session if the gesture ends before the end of the virtual reality program.
The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.
- Conditions
- Hematologic Neoplasms
- Being tested
- Virtual Reality, Kalinox
- Keywords
- Therapeutic Virtual Reality, Pain related medical procedure management, Anxiety management, Osteo-medullary biopsy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called Bliss
Bliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or stress and / or during painful care here osteo-medullary biopsy
KalinoxDrug
Also called Control
Usually take care of by a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen for the medical procedure (osteo-medullary biopsy)
| Study group | Role | What they receive |
|---|---|---|
| Kalinox® | Active comparator | The included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen (Kalinox®) Receives: Drug: Kalinox |
| Virtual Reality | Experimental | The included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a virtual reality (VR) session. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain
Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain).
Measured: Fifteen minutes after the osteo-medullary biopsy
Secondary outcomes (11)
Assessment of tolerance
Quotation of nausea, dizziness or headache according to CTCAE
Measured: During or within fifteen minutes after the osteo-medullary biopsy
Assessment of the anxiety by specific questionnaire
Anxiety will be evaluated by Inventory of situational anxiety and anxiety trait (IASTA scale)
Measured: Fifteen minutes after the osteo-medullary biopsy
Assessment of the anxiety by blood pressure measurement
Anxiety will be evaluated by bood pressure measurement
Measured: Fifteen minutes after the osteo-medullary biopsy
Assessment of the fear of pain by questionnaire
Fear of pain will be evaluated by a specific questionnaire
Measured: Assessment at Baseline
Assessment of the fear of pain by Visual Analog Scale
Fear of pain will be evaluated by a Visual Analog Scale (0 = no pain at 10 = worst possible pain).
Measured: Assessment at Baseline
Assessment of residual pain
Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain).
Measured: One month after the osteo-medullary biopsy
Assessment of investigator's satisfaction
Satisfaction will be evaluated by a questionnaire for investigators
Measured: Fifteen minutes after the osteo-medullary biopsy
Assessment of patient's satisfaction
Satisfaction will be evaluated by a questionnaire for patients
Measured: Fifteen minutes after the osteo-medullary biopsy
Assessment of nurse's satisfaction
Satisfaction will be evaluated by a questionnaire for nurses
Measured: Fifteen minutes after the osteo-medullary biopsy
Assessment of drug consumption related to the osteo-medullary biopsy (Xylocaine)
Drug consumption related to medical procedure will be evaluated by the number of bottle of xylocaine® (bottle of 20 mL, concentration of 10mg/mL) used
Measured: During the osteo-medullary biopsy
Assessment of drug consumption related to the osteo-medullary biopsy (Kalinox)
Drug consumption related to medical procedure will be evaluated by the duration of exposure of a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen (time in minutes)
Measured: During the osteo-medullary biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start6 Sep 2018
- Primary completion20 Apr 2020
- Study completion19 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Collaborators
- L'effet Papillon
- Responsible party
- Sponsor
- Investigators
- Katell LE DU, MD, Principal investigator, Centre Jean Bernard - Le Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483194
- Sponsor's protocol ID
- WP-2017-01
- Other IDs
- 2017-A02701-52
- Acronym
- REVEH
- Status last verified
- Jul 2019
- First submitted
- 15 Mar 2018
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Le Du K, Septans AL, Maloisel F, Vanquaethem H, Schmitt A, Le Goff M, Clavert A, Zinger M, Bourgeois H, Dupuis O, Denis F, Bouchard S. A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study. J Med Internet Res. 2023 Feb 15;25:e38619. doi: 10.2196/38619.
PubMed 36790852
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Virtual Reality : Impact on the Management of Pain and Anxiety Related to Hematology Care
- ClinicalTrials.gov ID
- NCT03483194
- Acronym / sponsor ID
- REVEH / WP-2017-01
- Conditions
- Hematologic Neoplasms
- Keywords
- Therapeutic Virtual Reality, Pain related medical procedure management, Anxiety management, Osteo-medullary biopsy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- WepromUniversity, hospital or other
- Collaborators
- L'effet Papillon
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 19 Jun 2020 (actual)
- First posted
- 30 Mar 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 management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment.
However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment.
Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness. The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.
Detailed description
Today, one third of the population suffers from anxiety and 20% of French people suffer from chronic pain. Many health situations or pathologies lead to difficult or painful care. The impact of drug solutions to relieve patients is often limited and more and more scientific studies are demonstrating the benefits of virtual reality to reduce pain, anxiety and addictions.
In 2011, following an experience of close to patient, a person created "l'Effet Papillon", a social enterprise that aims to create a concrete social impact in the lives of people with cancer, in situations of fragility or isolation and those who accompany them. Since 2011 the social enterprise has supported nearly 3,000 patients and today, the Butterfly Effect is a real partner of health actors by adopting a holistic approach to wellness in the face of disease and fragility.
Taking full advantage of the benefits of virtual reality that, used in medical settings, can reduce pain and anxiety, Bliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or or stress.
Bliss has been developed for and with patients in partnership with physicians, researchers and experts in virtual reality for therapeutic purposes.
Bliss offer a new tool for relaxation and well-being that relaxes and distracts users from moments of stress or anxiety.
The management of hematological malignancies justifies the completion of a complete assessment before the start of treatment. This assessment includes imaging tests (computed tomography, position emission tomography, cavitary scintigraphy), biology and very often an exploration of the bone marrow by anterior or posterior iliac biopsy. Pains related to the disease (node compression, invasion of solid organs) are taken care of at the diagnosis and often relieved by the start of the specific treatment.
However, pain related to medical procedure is often overlooked and can lead to psychological trauma in some patients who may refuse to repeat these essential actions to assess the response to treatment. Anxiety contributes to pain and various relaxation techniques have already proven their effectiveness.
During the osteo-medullary biopsy the patient will lie on his stomach with his hands positioned under the head. This position is the one recommended by the French Society of Hematology for an osteo-medullary biopsy.
The osteo-medullary biopsy remains independent of the object of the study and will be carried out according to the national recommendations.
For patients randomized to the "Standard" arm, the treatment will be the same as that proposed outside the study (a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen + 1 bottle of xylocaine® 20 mL at the concentration of 10 mg / mL).
For randomized patients in the "Virtual Reality" arm, the VR session should begin 5 minutes before the start of the procedure (+ 1 bottle of Xylocaine® 20 mL at a concentration of 10 mg / mL). The VR session will last between 15 and 30 minutes depending on the speed programmed. The patient can continue the session if the gesture ends before the end of the virtual reality program.
The goal of the protocol is to reduce the pain and anxiety associated with medical procedure by using virtual reality with a helmet proposed at the time of the gesture.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kalinox® | Active comparator | Drug: KalinoxThe included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen (Kalinox®) |
| Virtual Reality | Experimental | Device: Virtual RealityThe included patients in this group will have, during the intervention, a local anesthesia by xylocaine® 10 mg / mL (1 bottle of 20 mL) in complement of a virtual reality (VR) session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with malignant haematological pathology
- Patient who must have an osteo-medullary biopsy for diagnostic purposes
- Age ≥ 18 years
- Performance Status < 3
- Patient with no pelvic bone pain before inclusion
Key exclusion criteria (8 listed)
- Patient regularly taking antalgic treatments from stage 2 or 3
- Patient with congenital coagulation disorder or acquired or taking anticoagulant therapy such as: fluindione, acenocoumarol, warfarin, dabigatran, apixaban or rivaroxaban
- Contraindication to a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen administration: true allergy, severe respiratory failure requiring continuous oxygen therapy, emphysema, pneumothorax, history of air embolism or diving accident, epilepsy or uncontrolled neurological disorder, unsubstituted vitamin deficiency B12 and folic acid, abdominal gas distension
- Any contraindication to the use of the headset: pacemaker or other implanted medical device
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Virtual RealityAlso: BlissBliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or stress and / or during painful care here osteo-medullary biopsy | Device | Virtual Reality |
| KalinoxAlso: ControlUsually take care of by a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen for the medical procedure (osteo-medullary biopsy) | Drug | Kalinox® |
Primary outcome
Assessment of pain
Time frame: Fifteen minutes after the osteo-medullary biopsy
Pain will be evaluated by Visual Analog Scale (0 = no pain at 10 = worst possible pain).
11 secondary outcomes
Assessment of tolerance
Time frame: During or within fifteen minutes after the osteo-medullary biopsy
Assessment of the anxiety by specific questionnaire
Time frame: Fifteen minutes after the osteo-medullary biopsy
Assessment of the anxiety by blood pressure measurement
Time frame: Fifteen minutes after the osteo-medullary biopsy
Assessment of the fear of pain by questionnaire
Time frame: Assessment at Baseline
Assessment of the fear of pain by Visual Analog Scale
Time frame: Assessment at Baseline
Assessment of residual pain
Time frame: One month after the osteo-medullary biopsy
Assessment of investigator's satisfaction
Time frame: Fifteen minutes after the osteo-medullary biopsy
Assessment of patient's satisfaction
Time frame: Fifteen minutes after the osteo-medullary biopsy
Assessment of nurse's satisfaction
Time frame: Fifteen minutes after the osteo-medullary biopsy
Assessment of drug consumption related to the osteo-medullary biopsy (Xylocaine)
Time frame: During the osteo-medullary biopsy
Assessment of drug consumption related to the osteo-medullary biopsy (Kalinox)
Time frame: During the osteo-medullary biopsy
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 Jun 2020.
- Derived from this study: PubMed 36790852Le Du K, Septans AL, Maloisel F, Vanquaethem H, Schmitt A, Le Goff M, Clavert A, Zinger M, Bourgeois H, Dupuis O, Denis F, Bouchard S. A New Option for Pain Prevention Using a Therapeutic Virtual Reality Solution for Bone Marrow Biopsy (REVEH Trial): Open-Label, Randomized, Multicenter, Phase 3 Study. J Med Internet Res. 2023 Feb 15;25:e38619. doi: 10.2196/38619.
- Individual participant dataSharing planned: No
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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.
Katell LE DU, MD principal investigator
Centre Jean Bernard - Le Mans
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Virtual Reality and Kalinox in people with Hematologic Neoplasms, run by Weprom at 5 sites 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 8 inclusion and 8 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 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of pain (time frame: Fifteen minutes after the osteo-medullary biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483194, which also lists 1 linked publication.
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 Jun 2020.