Child-centered Communication and Anesthesia Use for MRI

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

Study Overview

• Status: Completed
• Conditions: Anxiety; Behavioral Problem of Child
• Intervention / Treatment: Behavioral: Child-centered communication

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Centro Hospitalar Universitário de São João
  • Porto, Portugal, 4200-319
    • Faculty of Medicine of the University of Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Child-centered communication; The child's preparation for the MRI scanning is conducted using a child-centered communication type of interaction	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
Active Comparator: 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	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
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia count	Number of children who perform the Magnetic Resonance Imaging exam using anesthesia	30 minutes (after the Magnetic Resonance Imaging)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Centro Hospitalar Universitário de São João, E.P.E.; Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS); Rede de Investigação em Saúde (RISE), Laboratório Associado; Faculty of Medicine (FMUP)
• Investigators: Principal Investigator: Irene P Carvalho, PhD, Universidade do Porto

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: MRI; anesthesia; children; patient-centered communication; toy simulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Problem Behavior
• Other Study ID Numbers: CASTRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data are confidential and will be shared only among the research team. Aggregate data can be shared with others only for research purposes and without any identifiers that might compromise the participant's anonimity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No