Clinical trial NCT05275621: Virtual Reality as a Substitute to Pharmacological Sedation During PICC Placement in Pediatric Patients
Official title: Virtual Reality for Vascular Access: a Multicenter Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Procedural Anxiety
Lead sponsor: ASST Fatebenefratelli Sacco
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In pediatric patients Peripherally Inserted Central Catheters (PICC) insertion requires pharmacological sedation provided by an anesthesiologist, which poses a certain degree of risks. In enrolled subjects, PICC insertion is tried without drug sedation, using an immersive virtual reality experience as a distraction technique. If the subjects is not able to keep still or if pain levels are too high, the virtual reality attempt is stopped and standard drug sedation is provided by a pediatric anesthesiologist.

Aim of study is to evaluate the feasibility of the PICC insertion procedure using the virtual reality distraction technique. The investigators hypothesize that this could avoid the need for drug sedation, reducing sedation-related risks and costs and reduce anxiety and pain related to the procedure.

Detailed description: A PICC is a central intravenous catheter inserted through a peripheral vein of the upper arm. In pediatric subjects, the insertion usually requires pharmacological sedation because of the anxiety and the pain experienced by the children during the procedure. Sedation inevitably poses a certain risk, particularly of airway obstruction, respiratory drive reduction en hemodynamic instability. Finally, costs are sensibly higher when sedation is required, since, besides the need for drugs and devices (e.g. for monitoring and airway management), an experienced pediatric anesthesiologist and a nurse are needed for providing sedation.

The investigators hypothesize that the application of virtual reality to children undergoing PICC placement, could avoid the need for drug sedation. This would result in a reduction in anxiety and pain related to the procedure and a potential reduction in costs. Moreover any possible adverse event related to pharmacological sedation would be avoided.

The material used for providing the virtual reality experience consist of a commercially available virtual reality headset (Oculus Quest 2 by Facebook Technologies ltd) and a dedicated software called "TOMMI" (developed by Softcare Studios Srl). Subjects find themselves in a virtual environment where they can play different games. The game which was chosen is called "drums", optimized for enhanced sensorimotor engagement and distraction from acute sensations such as pain. In this game subjects see three different drums they can beat with a "magic wand" they can control by moving the handheld controller. Geometric shapes in different colors fall from above indicating which drum to beat and at which time.

This game was chosen for several reasons: it can be played for sufficient time without getting excessively boring or tiring (the procedure usually lasts about half an hour); it can be easily played both by younger and older children; it does not require wide movements either of the head or of the upper limb holding the controller, and the opposite upper limb isn't involved in any way. Thus, distracting or even dangerous movements of the subject can be avoided, ensuring the successful completion of the procedure.

Subjects will be enrolled by the investigators in each participating center according to the inclusion and exclusion criteria. To participate informed consent has to be acquired in written form from both the caregivers and, if able to do so, also by the subjects.

Before the procedure multiple variables will be recorded to draw a baseline of each enrolled subject. These will include age, sex, BMI, previous experiences of sedation and of venipuncture and a psychological and behavioral profile using a self-administered questionnaire for caregivers (Child Behaviour Checklist - Achenbach ASEBA).

At the start of the procedure the Investigators will explain to the subject the use of the Virtual Reality viewer and will help him in positioning it. Patients will be monitored with continuous ECG and SpO2. All PICC placements will be carried out by trained and experienced implanter, in a dedicated room and under full barrier precautions. A pediatric anesthesiologist will always be available on site.

While arranging the sterile field, and at least for five minutes, the implanter will let the patient get fully immersed in the virtual environment. Meanwhile, the implanter will check that the child has correctly understood how to play the game.

In each patient, the site of insertion will be chosen after proper echographic evaluation of the vascular anatomy following the RaPeVA protocol as recommended by the Italian Vascular Access Society (IVAS). Entry site will be chosen in the middle third of the upper arm or in the "green zone" after the Zone Insertion Method™ by Robert Dawson. Venipuncture will be performed under ultrasound guidance and the catheter will be placed using a modified Seldinger technique over a tearaway introducer. Before introducing the dilator, the provider will inject the area with a local anesthetic and performed a small skin incision with a scalpel. Tip guidance and location was achieved through continuous intracavitary ECG.

Standard procedural sedation will be provided for those who won't tolerate the procedure using only the Virtual Reality immersion. No kind of active or passive restraint will be enforced during the whole procedure, the patients will be required to hold still for the whole time just by themselves.

Data will be analyzed with the R software in its latest version - Copyright (C) 2021 The R Foundation for Statistical Computing Platform: R Core Team (2021). R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/.

Continuous data will be reported as mean and standard deviation, categorical as number (percentage).

The investigators consider the accomplishment of the PICC placement procedure as the primary endpoint of our study (a dichotomous N/Y variable).

The procedure with the virtual reality is expected to be successful in the majority of all cases. Hence, in calculating the sample size (without finite population correction), the investigators consider an expected proportion of accomplishment of 0.95 with a precision (half width of the 95 percent confidence interval) of 0.04. This yields a sample size of 120 patients.

Eligibility criteria: Inclusion Criteria:

* Aged between 7 and 14 years old
* Indication for Vascular Access Device placement with the need for sedation
* Signed informed consent form by the subject's caregivers (commonly both parents)

Exclusion Criteria:

* Inability to fill in the rating scales
* Inability to experience Virtual Reality with TOMMI (e.g., eye diseases)
* Presence of disease that produces complete immobility
* Refusal to sign informed consent

Primary outcomes:
measure: Change in baseline Pain assessed by the Wong-Baker FACES Scale
timeFrame: Baseline and Five minutes after the procedure has been completed
measure: Change in baseline Anxiety assessed by a numeric rating scale
timeFrame: Baseline and Five minutes after the procedure has been completed
Secondary outcomes:
measure: Duration of the procedure
timeFrame: During the procedure
measure: Subject's satisfaction
timeFrame: through study completion, an average of three months
measure: Staff satisfaction
timeFrame: After study completion, expected six months
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: BS
city: Genova
country: Italy
facility: Ospedale Pediatrico Istituto Gianna Gaslini
state: GE
city: Milano
country: Italy
facility: Ospedale dei Bambini "Vittore Buzzi"
state: MI
city: Milano
country: Italy
facility: Fatebenefratelli Hospital
state: MI
city: Napoli
country: Italy
facility: AORN Pausilipon
city: Torino
country: Italy
facility: Regina Margherita Hospital
Study officials:
affiliation: ASST Fatebenefratelli Sacco
name: Marco Gemma, MD
role: PRINCIPAL_INVESTIGATOR
References: