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Child-centered Communication and Anesthesia Use for MRI

Primary Purpose

Behavioral Problem of Child, Anxiety

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

Child-centered communication

About this trial

This is an interventional prevention trial for Behavioral Problem of Child focused on measuring patient-centered communication, children, MRI, anesthesia, toy simulation

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro Hospitalar Universitário de São João
Faculty of Medicine of the University of Porto

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Child-centered communication

Magnetic Resonance Imaging (MRI) Simulation Toy

General information about the Magnetic Resonance Imaging (MRI) exam

Arm Description

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

The child's preparation for the MRI scanning is conducted through provision of general information about the MRI exam simulated with an MRI toy

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

Outcomes

Primary Outcome Measures

Anesthesia count

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

Secondary Outcome Measures

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

Change in heart rate frequency

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

Full Information

NCT ID

NCT05165576

First Posted

November 22, 2021

Last Updated

October 18, 2023

Sponsor

Universidade do Porto

Collaborators

Faculty of Medicine (FMUP), 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

1. Study Identification

Unique Protocol Identification Number

NCT05165576

Brief Title

Child-centered Communication and Anesthesia Use for MRI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

July 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidade do Porto

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Behavioral Problem of Child, Anxiety

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel assignment

Masking

ParticipantOutcomes Assessor

Masking Description

The investigator applied the intervention. The participant and the outcomes assessors were blind as to which group participants were assigned.

Allocation

Non-Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Child-centered communication

Arm Type

Experimental

Arm Description

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

Arm Title

Magnetic Resonance Imaging (MRI) Simulation Toy

Arm Type

Active Comparator

Arm Description

The child's preparation for the MRI scanning is conducted through provision of general information about the MRI exam simulated with an MRI toy

Arm Title

General information about the Magnetic Resonance Imaging (MRI) exam

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Child-centered communication

Intervention Description

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

Primary Outcome Measure Information:

Title

Anesthesia count

Description

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

Time Frame

30 minutes (after the Magnetic Resonance Imaging)

Secondary Outcome Measure Information:

Title

Change in self-reported anxiety

Description

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

Time Frame

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

Title

Change in heart rate frequency

Description

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

Time Frame

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

Other Pre-specified Outcome Measures:

Title

Satisfaction measurement

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Irene P Carvalho, PhD

Organizational Affiliation

Universidade do Porto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centro Hospitalar Universitário de São João

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Faculty of Medicine of the University of Porto

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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

Learn more about this trial

Child-centered Communication and Anesthesia Use for MRI

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