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

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

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: virtual reality Bliss Solution

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: valérie M LOIZEAU, Master; Phone Number: 0139274047; Email: vloizeau@chi-poissy-st-germain.fr
• Study Contact Backup: Name: julia M GROSS; Phone Number: 0139274047; Email: julia.gross@ght-yvelinesnord.fr

Study Locations

• France
  • Poissy, France
    • Recruiting
    • CH Poissy st Germain
    • Contact: Loizeau Valerie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: virtual reality Bliss Solution; use virtual reality Bliss Solution
No Intervention: current practice, without Bliss Solution; patient will receive the usual practice, local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year

Collaborators and Investigators

• Sponsor: Poissy-Saint Germain Hospital
• Investigators: Principal Investigator: valerie M LOIZEAU, CHI Poissy

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Anticipated): February 5, 2022
• Study Completion (Anticipated): June 5, 2022

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Virtual reality, pain, cancer
• Other Study ID Numbers: 2020-A00132-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No