Child-centered Communication and Anesthesia Use for MRI

Anxiety Clinical Trial

Official title:

The Influence of Child-centered Communication on Children's Anxiety and Use of Anesthesia for MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165576
• Other study ID #: CASTRO
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Behavioral Problem of Child
• Problem Behavior

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)