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Completed

NCT Number: NCT05165576

Child-centered Communication and Anesthesia Use for MRI

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

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Key information

Conditions

Behavioral Problem of Child Anxiety Anxiety Disorders Mental Disorders

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Hospitalar Universitário de São João, Porto, Portugal

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Child-centered communication

Behavioral

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

Primary outcomes

  1. Anesthesia count

    Time frame: 30 minutes (after the Magnetic Resonance Imaging)

    Number of children who perform the Magnetic Resonance Imaging exam using anesthesia

Secondary outcomes

  1. Change in self-reported anxiety

    Time frame: 20 minutes (before and after the child's preparation)

    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

  2. Change in heart rate frequency

    Time frame: 20 minutes (before and after the child's preparation)

    Change in anxiety levels before and after preparation for the Magnetic Resonance Imaging assessed through heart rate frequency

Other outcomes

  1. Satisfaction measurement

    Time frame: 20 minutes (after child preparation to do the Magnetic Resonance Imaging)

    Children's satisfaction with the interaction they had in preparation for the Magnetic Resonance Imaging, assessed through self-reported, Yes/No questions

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Centro Hospitalar De São João, E.P.E.
  • Centro de Investigação em Tecnologias e Serviços de Saúde
  • Rede de Investigação em Saúde

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2021
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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