Child-centered Communication and Anesthesia Use for MRI

NCT05165576 | Completed

• 1 other identifier: CASTRO
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Conditions

Behavioral Problem of Child; Anxiety

Keywords

patient-centered communication; children; MRI; anesthesia; toy simulation

Outcome Measures

Primary Outcomes (1)

• Anesthesia count

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

  30 minutes (after the Magnetic Resonance Imaging)

Secondary Outcomes (2)

• Change in self-reported anxiety

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

• Change in heart rate frequency

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

Other Outcomes (1)

• Satisfaction measurement

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

Study Arms (3)

Child-centered communication

EXPERIMENTAL

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

Behavioral: Child-centered communication

Magnetic Resonance Imaging (MRI) Simulation Toy

ACTIVE COMPARATOR

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

General information about the Magnetic Resonance Imaging (MRI) exam

NO INTERVENTION

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

Interventions

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

Child-centered communication; Magnetic Resonance Imaging (MRI) Simulation Toy

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Ages between four and 10 years old
• Having a medical request for the MRI in the hospital
• The MRI performed for the first time

You may not qualify if:

• Presenting cognitive, psychiatric or neurological conditions that prevented the understanding of communication
• Having any intra-body devices that impeded performance of the MRI exam

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Rede de Investigação em Saúde: collaborator

Study Sites (2)

Centro Hospitalar Universitário de São João

Porto, 4200-319, Portugal

Location

Faculty of Medicine of the University of Porto

Porto, 4200-319, Portugal

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Irene P Carvalho, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigator applied the intervention. The participant and the outcomes assessors were blind as to which group participants were assigned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 21, 2021
• Study Start: January 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 19, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)