Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter (RV-CIP)
Primary Purpose
Anxiety, CIP
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring virtual reality, anxiety, CIP
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.
Sites / Locations
- Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLSRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CIP procedure under virtual reality
Arm Description
CIP procedure under virtual reality
Outcomes
Primary Outcome Measures
Description of Patient's anxiety through his participation
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Evolution of Patient's anxiety during the procedure
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Secondary Outcome Measures
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
Effects of virtual reality on Pulse
The Pulse of the patient
Effects of virtual reality on Blood Pressure
The Blood Pressure of the patient (both systolic and diastolic)
Effects of virtual reality on memorization of the gesture
Measured by a Likert scale (Likert scale = Very Uncomfortable- Uncomfortable- Comfortable- Very Comfortable)
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
Effects of virtual reality on satisfaction and comfort during installation
Measured by a Simple Numerical Scale from 0 to 10
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)
Effects of virtual reality on caregiver satisfaction
Measured by a Simple Numerical Scale from 0 to 10
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05527379
Brief Title
Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
Acronym
RV-CIP
Official Title
Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
February 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, CIP
Keywords
virtual reality, anxiety, CIP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CIP procedure under virtual reality
Arm Type
Experimental
Arm Description
CIP procedure under virtual reality
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
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.
Primary Outcome Measure Information:
Title
Description of Patient's anxiety through his participation
Description
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Time Frame
through study completion, an average of 5 days
Title
Evolution of Patient's anxiety during the procedure
Description
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Effects of virtual reality on the pain perceived by the patient;
Description
The patient's pain, over the entire procedure, measured by Simple Numerical Scale : Pain from 0 to 10
Time Frame
Day 0 (after placing the port)
Title
Effects of virtual reality on Pulse
Description
The Pulse of the patient
Time Frame
Day 0 (before, during and after placing the port)
Title
Effects of virtual reality on Blood Pressure
Description
The Blood Pressure of the patient (both systolic and diastolic)
Time Frame
Day 0 (before, during and after placing the port)
Title
Effects of virtual reality on memorization of the gesture
Description
Measured by a Likert scale (Likert scale = Very Uncomfortable- Uncomfortable- Comfortable- Very Comfortable)
Time Frame
Day 0 (after placing the port) and through study completion between D+1 and D+5
Title
Effects of virtual reality on the perception of time
Description
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
Time Frame
Day 0 (after placing the port)
Title
Effects of virtual reality on satisfaction and comfort during installation
Description
Measured by a Simple Numerical Scale from 0 to 10
Time Frame
Day 0 (after placing the port)
Title
Effects of virtual reality on the caregiver's perception of the ease of the gesture
Description
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)
Time Frame
Day 0 (after placing the port)
Title
Effects of virtual reality on caregiver satisfaction
Description
Measured by a Simple Numerical Scale from 0 to 10
Time Frame
Day 0 (after placing the port)
Title
Effects of virtual reality on the duration of the intervention
Description
Duration of the procedure in minutes between the patient entering and leaving the operating room
Time Frame
Day 0 (after placing the port)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie de FILIPPIS
Phone
04 78 86 28 73
Email
annie.de-filippis@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie VICENTE
Phone
+33 472 115 439
Email
stephanie.vicente01@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annie de FILIPPIS
Organizational Affiliation
HCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLS
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annie de FILIPPIS
Phone
04 78 86 28 73
Email
annie.de-filippis@chu-lyon.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Interest of Virtual Reality to Reduce Patient Anxiety During the Placement of a Percutaneous Implantable Port Catheter
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