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

NCT ID: NCT05015790

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-05

Study Completion Date

2022-06-05

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

virtual reality Bliss Solution

Intervention Type DEVICE

use virtual reality Bliss Solution

current practice, without Bliss Solution

patient will receive the usual practice, local anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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virtual reality Bliss Solution

use virtual reality Bliss Solution

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poissy-Saint Germain Hospital

OTHER

Sponsor Role lead

Responsible Party

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Valérie LOIZEAU

paramedical research coordination

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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valerie M LOIZEAU

Role: PRINCIPAL_INVESTIGATOR

CHI Poissy

Locations

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CH Poissy st Germain

Poissy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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valérie M LOIZEAU, Master

Role: CONTACT

0139274047

julia M GROSS

Role: CONTACT

0139274047

Facility Contacts

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Loizeau Valerie

Role: primary

Other Identifiers

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2020-A00132-37

Identifier Type: -

Identifier Source: org_study_id

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