Virtual Reality as a Substitute to Pharmacological Sedation During PICC Placement in Pediatric Patients

NCT05275621 | Unknown

• 1 other identifier: 2021/ST/291
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 6

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.

Conditions

Procedural Anxiety

Outcome Measures

Primary Outcomes (2)

• Change in baseline Pain assessed by the Wong-Baker FACES Scale

  The Wong-Baker FACES Scale is a validated scale used to assess the experienced pain in subjects from three years of age. It consists of six different faces: the first represents no pain at all and is described by the words "No Hurt" and the last one represents a pain score of "10 out of 10" on a numeric rating scale, and indicates "hurts worst."

  Baseline and Five minutes after the procedure has been completed

• Change in baseline Anxiety assessed by a numeric rating scale

  Anxiety is assessed through a numeric rating scale ranging from zero representing no anxiety at all, up to ten representing the worst anxiety level.

  Baseline and Five minutes after the procedure has been completed

Secondary Outcomes (3)

• Duration of the procedure

  During the procedure

• Subject's satisfaction

  through study completion, an average of three months

• Staff satisfaction

  After study completion, expected six months

Study Arms (1)

Subjects requiring PICC

EXPERIMENTAL

Subjects requiring a PICC. Positioning is first tried under Virtual Reality distraction. If failure (movements or discomfort) standard procedural sedation is applied. No kind of physical restraint is allowed.

Device: Virtual Reality; Procedure: PICC positioning

Interventions

Virtual Reality DEVICE

A Virtual Reality game is provided through a headset. Subjects play in a virtual environment. Positioning of the headset occurs before starting the procedure and is maintained throughout the procedure. The headset used will be "Oculus Rift 2 by Facebook Tech. ltd.". The software is designed specifically for the purpose by Softcare Studios. The "game" played is called "Drums".

Subjects requiring PICC

PICC positioning PROCEDURE

A PICC is inserted under ultrasound guidance through a modified Seldinger technique in a deep vein of the upper arm. The skin is infiltrated with 0.5-1ml 2% lidocaine before dilation of the skin. Tip guidance and positioning is achieved through intracavitary ECG.

Subjects requiring PICC

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• ASST Fatebenefratelli Sacco: lead

Study Sites (6)

Spedali Civili di Brescia

Brescia, BS, 25123, Italy

Location

Ospedale Pediatrico Istituto Gianna Gaslini

Genova, GE, Italy

Location

Ospedale dei Bambini "Vittore Buzzi"

Milan, MI, 20100, Italy

Location

Fatebenefratelli Hospital

Milan, MI, 20121, Italy

Location

AORN Pausilipon

Napoli, Italy

Location

Regina Margherita Hospital

Torino, 10126, Italy

Location

Study Officials

• Marco Gemma, MD

  ASST Fatebenefratelli Sacco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Gemma, MD

CONTACT

+39 0263632414; marco.gemma@asst-fbf-sacco.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesia and Intensive Care Unit

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 11, 2022
• Study Start: March 1, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: March 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)