Clinical trial NCT05527379: Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
Official title: Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
CIP
Keywords: virtual reality
anxiety
CIP
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-09-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Vascular Access Unit (UAV) of the Lyon Sud Hospital Center is the first unit within a French public establishment where the Regional Health Agency (ARS) has authorized that medical procedures for the installation of central venous access be performed by nurses.

The installation of CIP represents an anxiety-provoking step for the patient, because the gesture, which consists of inserting a box under the skin, connected to a catheter, placed in a deep vein, involves uncomfortable, even painful moments. In the UAV, the installation of this device is carried out in the operating room, without premedication and only under local anesthesia. Affected patients usually have a diagnosis of serious illness (oncology).

Virtual Reality (VR) simulates the physical presence of the patient in an environment artificially generated by software. Many applications have already been evaluated in different health sectors, the investigators would like to show its interest in reducing patient anxiety during CIP placement under local anesthesia, without premedication.

The medical device used is Lumeen. It is a Class I medical device software within the meaning of Regulation (EU) 2017/745, CE marked. In the context of research, the Relaxation module is used. This module is the one intended for the management of anxiety and pain induced by medical procedures in adults and children over 6 years of age. It allows to perform immersions in 360° videos in real shots or computer-generated images, accompanied by natural sounds, relaxing music and a relaxation script recorded by hypnotherapists. The duration of an immersion can be adjusted according to the needs of the medical procedure..


Eligibility criteria: Inclusion Criteria:

* Adult patient ≥18 years old
* Patient operated on an outpatient basis and available for a phone call between D+1 and D+5
* Patient operated for a 1st pose of CIP at the UAV
* Patient whose anxiety measured by ENS Anxiety is at least 4/10 at entry
* Patient having signed the Informed Consent
* Patient affiliated to a social security

Exclusion Criteria:

* Patient not sufficiently fluent in the French language, in the judgment of the investigator, to allow him a good understanding of the implementation and the interest of the virtual reality headset material;
* Patient with motion sickness;
* Patient participating in another study who, in the judgment of the investigator, could interfere with the results of this research protocol;
* Patient deprived of liberty or placed under guardianship or curators;
* Pregnant or breastfeeding women;
* Patient with a history of epilepsy ;
* Patient with a pacemaker or pacemaker;
* Patient with psychiatric disorders of a psychotic nature in the acute phase or visual hallucinations;
* Patient under anxiolytic treatment;
* Patient presenting wounds or infections on the level of the head not allowing the installation of the virtual reality helmet.

Primary outcomes:
measure: Description of Patient's anxiety through his participation
timeFrame: through study completion, an average of 5 days
measure: Evolution of Patient's anxiety during the procedure
timeFrame: Day 0
Secondary outcomes:
measure: Effects of virtual reality on the pain perceived by the patient;
timeFrame: Day 0 (after placing the port)
measure: Effects of virtual reality on Pulse
timeFrame: Day 0 (before, during and after placing the port)
measure: Effects of virtual reality on Blood Pressure
timeFrame: Day 0 (before, during and after placing the port)
measure: Effects of virtual reality on memorization of the gesture
timeFrame: Day 0 (after placing the port) and through study completion between D+1 and D+5
measure: Effects of virtual reality on the perception of time
timeFrame: Day 0 (after placing the port)
measure: Effects of virtual reality on satisfaction and comfort during installation
timeFrame: Day 0 (after placing the port)
measure: Effects of virtual reality on the caregiver's perception of the ease of the gesture
timeFrame: Day 0 (after placing the port)
measure: Effects of virtual reality on caregiver satisfaction
timeFrame: Day 0 (after placing the port)
measure: Effects of virtual reality on the duration of the intervention
timeFrame: Day 0 (after placing the port)
Other outcomes:
Locations:
city: Pierre Bénite
country: France
facility: Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLS
Study officials:
affiliation: HCL
name: Annie de FILIPPIS
role: PRINCIPAL_INVESTIGATOR
References: