Child-centered Communication and Anesthesia Use for MRI

NCT ID: NCT05165576

Last Updated: 2023-10-19

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

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

Detailed Description

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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).

Conditions

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Behavioral Problem of Child Anxiety

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel assignment
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The investigator applied the intervention. The participant and the outcomes assessors were blind as to which group participants were assigned.

Study Groups

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Child-centered communication

The child's preparation for the MRI scanning is conducted using a child-centered communication type of interaction

Group Type EXPERIMENTAL

Child-centered communication

Intervention Type BEHAVIORAL

The child is asked for ideas, fears and concerns regarding the magnetic resonance imaging exam and responses are tailored to these individual needs

Magnetic Resonance Imaging (MRI) Simulation Toy

The child's preparation for the MRI scanning is conducted through provision of general information about the MRI exam simulated with an MRI toy

Group Type ACTIVE_COMPARATOR

Child-centered communication

Intervention Type BEHAVIORAL

The child is asked for ideas, fears and concerns regarding the magnetic resonance imaging exam and responses are tailored to these individual needs

General information about the Magnetic Resonance Imaging (MRI) exam

The child's preparation for the MRI scanning is based on the provision of routine information about the MRI exam

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role collaborator

Centro de Investigação em Tecnologias e Serviços de Saúde

OTHER

Sponsor Role collaborator

Rede de Investigação em Saúde

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irene P Carvalho, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

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Centro Hospitalar Universitário de São João

Porto, , Portugal

Site Status

Faculty of Medicine of the University of Porto

Porto, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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CASTRO

Identifier Type: -

Identifier Source: org_study_id

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