Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language

Completed

• Conditions: Delirium
• Interventions: Behavioral: CAPD scale

• Registration Number: NCT04589767
• Lead Sponsor: Azienda Ospedaliera di Padova

Brief Summary

70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

Detailed Description

The psychometric validation study will take place in the PICU of the Hospital of Padua. CAPD translation and cultural adaptation was developed within the Pediatric Cardiac Surgery Intensive Care Unit of the Federico II Polyclinic.

In this study we aim to perform the psychometric validation. 70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

The score will be recorded in a data collection card, all the cards will be collected and then analyzed.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-19
• Primary Completion: 2021-08-30
• Study Completion: 2021-09-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• PICU admission
• Comfort Behavioral Score > 11

Exclusion Criteria

• use of neuromuscular blocking agents at the moment of CAPD evaluation
• Comfort Behavioral Score < 11

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children admitted in PICU	CAPD scale	children enrolled will be evaluated by two nurses using CAPD Italian version. One nurse will repeat the evaluation two minutes later.

Primary Outcome Measures

Name	Time	Method
inter-evaluator agreement	1 hour during PICU stay	CAPD evaluation by two operators
intra-evaluator agreement	2 minutes during PICU stay	CAPD evaluation by two operators

Trial Locations

Locations (1)

PICU University Hospital of Padova; 🇮🇹 Padova, Italy