Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety
LURVIDOC
1 other identifier
interventional
120
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Feb 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2021
CompletedFirst Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2022
CompletedAugust 30, 2021
August 1, 2021
1 year
February 12, 2021
August 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
one year
Secondary Outcomes (1)
The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.
one year
Study Arms (2)
use of virtual reality Bliss Solution
EXPERIMENTALin 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 INTERVENTIONpatient will receive the usual practice, local anesthesia
Interventions
use virtual reality Bliss Solution
Eligibility Criteria
You may qualify if:
- Adult patient over 18 years of age
- Patient suffering from a cancerous pathology
- Patient taken care of for the installation of the ICH
You may not qualify if:
- Patient does not speak and understand French
- Patient who has had a previous ICH installation
- Patient with cognitive impairment
- Patient with pain perception disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CH Poissy st Germain
Poissy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
valerie M LOIZEAU
CHI Poissy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- paramedical research coordination
Study Record Dates
First Submitted
February 12, 2021
First Posted
August 20, 2021
Study Start
February 5, 2021
Primary Completion
February 5, 2022
Study Completion
June 5, 2022
Last Updated
August 30, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share