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

NCT ID: NCT04589767

Last Updated: 2022-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-09-30

Brief Summary

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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

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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.

Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CAPD scale

Intervention Type BEHAVIORAL

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

Interventions

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CAPD scale

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Padova

OTHER

Sponsor Role lead

Responsible Party

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angela amigoni

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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angela amigoni

Role: PRINCIPAL_INVESTIGATOR

University Hospital Padova

Locations

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PICU University Hospital of Padova

Padua, , Italy

Site Status

Countries

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Italy

Other Identifiers

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4792/AO/19

Identifier Type: -

Identifier Source: org_study_id

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