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

NCT05275621 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-03-11

No results posted yet for this study

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

Interventions

DEVICE

Virtual Reality

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".

PROCEDURE

PICC positioning

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.

Sponsors & Collaborators

  • ASST Fatebenefratelli Sacco

    lead OTHER

Principal Investigators

  • Marco Gemma, MD · ASST Fatebenefratelli Sacco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05275621 on ClinicalTrials.gov