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CompletedNCT04589767Updated Mar 2, 2022

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

An observational study in Delirium, sponsored by Azienda Ospedaliera di Padova. Completed at 1 site in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Azienda Ospedaliera di Padova · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
70
Ages
Up to 18 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Delirium

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Keywords

  • delirium
  • monitoring
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 70 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Azienda Ospedaliera di Padova is the lead sponsor of 36 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children admitted in PICU

Inclusion criteria

  • PICU admission
  • Comfort Behavioral Score > 11

Exclusion criteria

Exclusion Criteria:

  • use of neuromuscular blocking agents at the moment of CAPD evaluation
  • Comfort Behavioral Score \< 11
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
70 participants (actual)
Patient registry
No

Groups and cohorts

  • children admitted in PICU

    children enrolled will be evaluated by two nurses using CAPD Italian version. One nurse will repeat the evaluation two minutes later.

    Behavioral: CAPD scale

Interventions

  • BehavioralCAPD scale

    Two nurses will apply CAPD scale. One nurse will repeat the CAPD evaluation two minutes later

06

What researchers measure

Primary outcomes

  1. inter-evaluator agreement

    CAPD evaluation by two operators

    Time frame: 1 hour during PICU stay

  2. intra-evaluator agreement

    CAPD evaluation by two operators

    Time frame: 2 minutes during PICU stay

07

Study locations

1 site
  • PICU University Hospital of Padova
    Padova, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04589767
Lead sponsor
Azienda Ospedaliera di Padova
Responsible party
angela amigoni (MD, Azienda Ospedaliera di Padova) — Principal investigator
First posted
Oct 19, 2020
Start date
Jan 1, 2020
Primary completion
Aug 30, 2021
Completion
Sep 30, 2021
Last update
Mar 2, 2022

Study contacts

angela amigoni
principal investigator · University Hospital Padova

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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