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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05165576
Other study ID # CASTRO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2020

Study information

Verified date November 2021
Source Universidade do Porto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is to study the influence of child-centered communication on children's anxiety, satisfaction and the use of anesthesia for MRI


Description:

This study seeks to inspect the influence of a child-centered communication (CCC) on anesthesia use in magnetic resonance imaging (MRI) exams among four- to 10-year-old children. Children's levels of anxiety and satisfaction with the interaction also are assessed. Children are divided into three groups by order of arrival. Group 1 receives routine information about the MRI and simulates it with an MRI toy (EG1). Group 2 simulates the exam with the toy and receives the CCC. These two groups are compared with a third group of children who had received only the routine information about the exam and who served as a comparison group (CG).


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility Inclusion Criteria: - Ages between four and 10 years old - Having a medical request for the MRI in the hospital - The MRI performed for the first time Exclusion Criteria: - Presenting cognitive, psychiatric or neurological conditions that prevented the understanding of communication - Having any intra-body devices that impeded performance of the MRI exam

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Child-centered communication
The child is asked for ideas, fears and concerns regarding the magnetic resonance imaging exam and responses are tailored to these individual needs

Locations

Country Name City State
Portugal Centro Hospitalar Universitário de São João Porto
Portugal Faculty of Medicine of the University of Porto Porto

Sponsors (5)

Lead Sponsor Collaborator
Universidade do Porto Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS), Centro Hospitalar Universitário de São João, E.P.E., Faculty of Medicine (FMUP), Rede de Investigação em Saúde (RISE), Laboratório Associado

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Other Satisfaction measurement Children's satisfaction with the interaction they had in preparation for the Magnetic Resonance Imaging, assessed through self-reported, Yes/No questions 20 minutes (after child preparation to do the Magnetic Resonance Imaging)
Primary Anesthesia count Number of children who perform the Magnetic Resonance Imaging exam using anesthesia 30 minutes (after the Magnetic Resonance Imaging)
Secondary Change in self-reported anxiety Change in anxiety levels before and after preparation for the Magnetic Resonance Imaging, assessed through a self-report question responded on a 1 ("very calm") to 5 ("very scared") scale 20 minutes (before and after the child's preparation)
Secondary Change in heart rate frequency Change in anxiety levels before and after preparation for the Magnetic Resonance Imaging assessed through heart rate frequency 20 minutes (before and after the child's preparation)
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