Child-centered Communication and Anesthesia Use for MRI

Not Applicable

Completed

• Conditions: Anxiety; Behavioral Problem of Child
• Interventions: Behavioral: Child-centered communication

• Registration Number: NCT05165576
• Lead Sponsor: Universidade do Porto

Brief 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

Detailed 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).

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-12-31
• Status Verified: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-21
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child-centered communication	Child-centered communication	The child's preparation for the MRI scanning is conducted using a child-centered communication type of interaction
Magnetic Resonance Imaging (MRI) Simulation Toy	Child-centered communication	The child's preparation for the MRI scanning is conducted through provision of general information about the MRI exam simulated with an MRI toy

Primary Outcome Measures

Name	Time	Method
Anesthesia count	30 minutes (after the Magnetic Resonance Imaging)	Number of children who perform the Magnetic Resonance Imaging exam using anesthesia

Secondary Outcome Measures

Name	Time	Method
Change in self-reported anxiety	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
Change in heart rate frequency	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

Trial Locations

Locations (2)

Centro Hospitalar Universitário de São João; 🇵🇹 Porto, Portugal

Faculty of Medicine of the University of Porto; 🇵🇹 Porto, Portugal