CancerLURVIDOCNCT05015790
Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety
A study testing virtual reality Bliss Solution in people with Cancer, run by Poissy-Saint Germain Hospital at 1 site in France.
Trial summary
To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- virtual reality Bliss Solution
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2021to 5 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patient over 18 years of age
- Patient suffering from a cancerous pathology
- Patient taken care of for the installation of the ICH
Who cannot join
- Patient does not speak and understand French
- Patient who has had a previous ICH installation
- Patient with cognitive impairment
- Patient with pain perception disorder
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CH Poissy st Germain
Poissy
Loizeau Valerie
About this study
Official title: Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety During the Insertion of the Implantable Catheter Chamber in the Operating Theatre in Cancer Patients
To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer
Read the detailed description
The insertion of an implantable catheter chamber (ICH) is indicated in the case of prolonged or repeated infusions, particularly when the products injected are toxic to the venous walls, as is the case with cancer chemotherapy.
The insertion of a ICH is carried out in the operating theatre, usually under local anaesthesia. Although this operation is potentially painful and stressful, the question of its perception by the patient has not yet been addressed, nor the relevance of using non-invasive devices to alleviate the pain felt by the patient.
Among the proposals, virtual reality glasses Bliss Solution would be likely to improve patient management when a ICH is performed under local anaesthesia in the operating theatre.
The evaluation will be made on the contribution of the use of the Bliss Solution virtual reality glasses in the management of pain during the installation of an ICH under local anesthesia in the operating room.
- Conditions
- Cancer
- Being tested
- virtual reality Bliss Solution
- Keywords
- Virtual reality, pain, cancer
- Medical subject headings
- Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality Bliss SolutionDevice
use virtual reality Bliss Solution
| Study group | Role | What they receive |
|---|---|---|
| use of virtual reality Bliss Solution | Experimental | in the experimental arm the patient will receive the usual practice associated with a virtual reality session (20 minutes renewable) in a world chosen with the patient beforehand Receives: Device: virtual reality Bliss Solution |
| current practice, without Bliss Solution | No intervention | patient will receive the usual practice, local anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main assessment criterion is measured using the Visual Analogue Scale (VAS), which allows a self-assessment of the level of pain felt by the patient using a ruler rated from 1 to 10.
At the same the main evaluation criterion is a visual analogue scale (VAS) allowing a self-evaluation of the pain felt by the patient during the surgical intervention. The patient will rate their pain, on a scale from 0 for no pain to 10 for very severe pain. the data will be recorded at the time of the patient's installation, during the venipuncture and at the creation of the pocket.
Measured: one year
Secondary outcomes (1)
The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.
The anxiety felt by patients during the operation will be evaluated with the Hamilton Score.The Hamilton Depression Scale is a test for the intensity of anxiety and depressive disorders that can be used by everyone. It has 14 rated items from 0 to 3. The higher the score, the more severe the anxiety disorders. The minimum score is 0 and the maximum score is 42.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start5 Feb 2021
- Primary completion5 Feb 2022 (estimated)
- Study completion5 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valérie LOIZEAU, Poissy-Saint Germain Hospital
- Investigators
- valerie M LOIZEAU, Principal investigator, CHI Poissy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015790
- Sponsor's protocol ID
- 2020-A00132-37
- Acronym
- LURVIDOC
- Status last verified
- Aug 2021
- First submitted
- 12 Feb 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety During the Insertion of the Implantable Catheter Chamber in the Operating Theatre in Cancer Patients
- ClinicalTrials.gov ID
- NCT05015790
- Acronym / sponsor ID
- LURVIDOC / 2020-A00132-37
- Conditions
- Cancer
- Keywords
- Virtual reality, pain, cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 5 Feb 2022 (estimated)
- Study completion
- 5 Jun 2022 (estimated)
- First posted
- 20 Aug 2021 (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.
To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer
Detailed description
The insertion of an implantable catheter chamber (ICH) is indicated in the case of prolonged or repeated infusions, particularly when the products injected are toxic to the venous walls, as is the case with cancer chemotherapy.
The insertion of a ICH is carried out in the operating theatre, usually under local anaesthesia. Although this operation is potentially painful and stressful, the question of its perception by the patient has not yet been addressed, nor the relevance of using non-invasive devices to alleviate the pain felt by the patient.
Among the proposals, virtual reality glasses Bliss Solution would be likely to improve patient management when a ICH is performed under local anaesthesia in the operating theatre.
The evaluation will be made on the contribution of the use of the Bliss Solution virtual reality glasses in the management of pain during the installation of an ICH under local anesthesia in the operating room.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| use of virtual reality Bliss Solution | Experimental | Device: virtual reality Bliss Solutionin the experimental arm the patient will receive the usual practice associated with a virtual reality session (20 minutes renewable) in a world chosen with the patient beforehand |
| current practice, without Bliss Solution | No intervention | –patient will receive the usual practice, local anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient over 18 years of age
- Patient suffering from a cancerous pathology
- Patient taken care of for the installation of the ICH
Key exclusion criteria (4 listed)
- Patient does not speak and understand French
- Patient who has had a previous ICH installation
- Patient with cognitive impairment
- Patient with pain perception disorder
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 reality Bliss Solutionuse virtual reality Bliss Solution | Device | use of virtual reality Bliss Solution |
Primary outcome
The main assessment criterion is measured using the Visual Analogue Scale (VAS), which allows a self-assessment of the level of pain felt by the patient using a ruler rated from 1 to 10.
Time frame: one year
At the same the main evaluation criterion is a visual analogue scale (VAS) allowing a self-evaluation of the pain felt by the patient during the surgical intervention. The patient will rate their pain, on a scale from 0 for no pain to 10 for very severe pain. the data will be recorded at the time of the patient's installation, during the venipuncture and at the creation of the pocket.
1 secondary outcome
The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- 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.
valerie M LOIZEAU principal investigator
CHI Poissy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality Bliss Solution in people with Cancer, run by Poissy-Saint Germain Hospital 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact valérie M LOIZEAU, Master (0139274047, vloizeau@chi-poissy-st-germain.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main assessment criterion is measured using the Visual Analogue Scale (VAS), which allows a self-assessment of the level of pain felt by the patient using a ruler rated from 1 to 10. (time frame: one year). 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 30 Aug 2021.