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

Not Applicable

• Conditions: Cancer
• Interventions: Device: virtual reality Bliss Solution

• Registration Number: NCT05015790
• Lead Sponsor: Poissy-Saint Germain Hospital

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

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 Timeline

• Study Start: 2021-02-05
• Study First Submitted: 2021-02-12
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-20
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-30
• Primary Completion: 2022-02-05
• Study Completion: 2022-06-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
use of virtual reality Bliss Solution	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

CH Poissy st Germain; 🇫🇷 Poissy, France