Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter

NCT05527379 | Completed

• 1 other identifier: 69HCL19_0824
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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..

Conditions

Anxiety; CIP

Keywords

virtual reality; anxiety; CIP

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Effects of virtual reality on the pain perceived by the patient;

  Day 0 (after placing the port)

• Effects of virtual reality on Pulse

  Day 0 (before, during and after placing the port)

• Effects of virtual reality on Blood Pressure

  Day 0 (before, during and after placing the port)

• Effects of virtual reality on memorization of the gesture

  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

  Day 0 (after placing the port)

Study Arms (1)

CIP procedure under virtual reality

EXPERIMENTAL

CIP procedure under virtual reality

Device: Virtual reality

Interventions

Virtual reality DEVICE

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.

CIP procedure under virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLS

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Annie de FILIPPIS

  HCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: September 2, 2022
• Study Start: January 5, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)