LURVIDOC: Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety

Sponsor
Poissy-Saint Germain Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05015790
Collaborator
(none)
120
1
2
15.9
7.5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: virtual reality Bliss Solution
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 5, 2021
Anticipated Primary Completion Date :
Feb 5, 2022
Anticipated Study Completion Date :
Jun 5, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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. [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.

Secondary Outcome Measures

  1. The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CH Poissy st Germain Poissy France

Sponsors and Collaborators

  • Poissy-Saint Germain Hospital

Investigators

  • Principal Investigator: valerie M LOIZEAU, CHI Poissy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Valérie LOIZEAU, paramedical research coordination, Poissy-Saint Germain Hospital
ClinicalTrials.gov Identifier:
NCT05015790
Other Study ID Numbers:
  • 2020-A00132-37
First Posted:
Aug 20, 2021
Last Update Posted:
Aug 30, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Valérie LOIZEAU, paramedical research coordination, Poissy-Saint Germain Hospital

Study Results

No Results Posted as of Aug 30, 2021