Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter (RV-CIP)

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..

Study Overview

• Status: Completed
• Conditions: Anxiety; CIP
• Intervention / Treatment: Device: Virtual reality

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pierre Bénite, France, 69495
    • Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CIP procedure under virtual reality

Device: Virtual reality; When the patient is ready to have the CIP procedure the tablet will be presented to him so that he can view and choose the immersive film that suits him best. Before fitting the virtual reality helmet and the start of the film, the patient's anxiety will be evaluated by ENS on a scale of 0 to 10 . The patient's anxiety will also be evaluated at the end of the procedure. The patient will be contacted by telephone by an investigator between D+1 and D+5 in order to reassess and remotely from the pose, his memorization of the gesture and to look for adverse events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of Patient's anxiety through his participation	Evaluated by Simple Numerical Scale : Anxiety from 0 to 10	through study completion, an average of 5 days
Evolution of Patient's anxiety during the procedure	Evaluated by Simple Numerical Scale : Anxiety from 0 to 10	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of virtual reality on the pain perceived by the patient;	The patient's pain, over the entire procedure, measured by Simple Numerical Scale : Pain from 0 to 10	Day 0 (after placing the port)
Effects of virtual reality on Pulse	The Pulse of the patient	Day 0 (before, during and after placing the port)
Effects of virtual reality on Blood Pressure	The Blood Pressure of the patient (both systolic and diastolic)	Day 0 (before, during and after placing the port)
Effects of virtual reality on memorization of the gesture	Measured by a Likert scale (Likert scale = Very Uncomfortable- Uncomfortable- Comfortable- Very Comfortable)	Day 0 (after placing the port) and through study completion between D+1 and D+5
Effects of virtual reality on the perception of time	Perception of time in minutes estimated by the patient (In your opinion, how long did the gesture last? and difference with the actual duration of the gesture	Day 0 (after placing the port)
Effects of virtual reality on satisfaction and comfort during installation	Measured by a Simple Numerical Scale from 0 to 10	Day 0 (after placing the port)
Effects of virtual reality on the caregiver's perception of the ease of the gesture	Measured by a Likert scale, (Likert scale = Easy-patient Immobile - appearing relaxed / Moderately Easy-Patient slightly mobile- Reactive / Difficult-Patient having difficulty in staying Still- Very reactive- Seeming tense)	Day 0 (after placing the port)
Effects of virtual reality on caregiver satisfaction	Measured by a Simple Numerical Scale from 0 to 10	Day 0 (after placing the port)
Effects of virtual reality on the duration of the intervention	Duration of the procedure in minutes between the patient entering and leaving the operating room	Day 0 (after placing the port)

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Annie de FILIPPIS, HCL

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 20, 2023

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 2, 2022

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: anxiety; virtual reality; CIP
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 69HCL19_0824

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
• product manufactured in and exported from the U.S.: No