Unité d'Accès Vasculaire/Secteur Anesthésie Blocs - CHLS
Pierre-Bénite, 69495, France
NCT Number: NCT05527379
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..
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pierre-Bénite, 69495, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: through study completion, an average of 5 days
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Time frame: Day 0
Evaluated by Simple Numerical Scale : Anxiety from 0 to 10
Time frame: Day 0 (after placing the port)
The patient's pain, over the entire procedure, measured by Simple Numerical Scale : Pain from 0 to 10
Time frame: Day 0 (before, during and after placing the port)
The Pulse of the patient
Time frame: Day 0 (before, during and after placing the port)
The Blood Pressure of the patient (both systolic and diastolic)
Time frame: Day 0 (after placing the port) and through study completion between D+1 and D+5
Measured by a Likert scale (Likert scale = Very Uncomfortable- Uncomfortable- Comfortable- Very Comfortable)
Time frame: Day 0 (after placing the port)
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)
Measured by a Simple Numerical Scale from 0 to 10
Time frame: Day 0 (after placing the port)
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)
Measured by a Simple Numerical Scale from 0 to 10
Time frame: Day 0 (after placing the port)
Duration of the procedure in minutes between the patient entering and leaving the operating room
Hospices Civils de Lyon
Other
Acronym: RV-CIP
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