Status:
UNKNOWN
Virtual Reality as a Substitute to Pharmacological Sedation During PICC Placement in Pediatric Patients
Lead Sponsor:
ASST Fatebenefratelli Sacco
Conditions:
Procedural Anxiety
Eligibility:
All Genders
7-14 years
Phase:
NA
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 sub...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05275621
Start Date
March 1 2022
End Date
April 1 2022
Last Update
March 11 2022
Active Locations (6)
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1
Spedali Civili di Brescia
Brescia, BS, Italy, 25123
2
Ospedale Pediatrico Istituto Gianna Gaslini
Genova, GE, Italy
3
Ospedale dei Bambini "Vittore Buzzi"
Milan, MI, Italy, 20100
4
Fatebenefratelli Hospital
Milan, MI, Italy, 20121