- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05015790
Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety (LURVIDOC)
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: valérie M LOIZEAU, Master
- Telefonnummer: 0139274047
- E-mail: vloizeau@chi-poissy-st-germain.fr
Undersøgelse Kontakt Backup
- Navn: julia M GROSS
- Telefonnummer: 0139274047
- E-mail: julia.gross@ght-yvelinesnord.fr
Studiesteder
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-
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Poissy, Frankrig
- Rekruttering
- CH Poissy st Germain
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Kontakt:
- Loizeau Valerie
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Adult patient over 18 years of age
- Patient suffering from a cancerous pathology
- Patient taken care of for the installation of the ICH
Exclusion Criteria:
- Patient does not speak and understand French
- Patient who has had a previous ICH installation
- Patient with cognitive impairment
- Patient with pain perception disorder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: use of virtual reality Bliss Solution
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
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use virtual reality Bliss Solution
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Ingen indgriben: current practice, without Bliss Solution
patient will receive the usual practice, local anesthesia
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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.
Tidsramme: one year
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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.
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one year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.
Tidsramme: one year
|
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.
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one year
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: valerie M LOIZEAU, CHI Poissy
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2020-A00132-37
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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