Child-centered Communication and Anesthesia Use for MRI

• Sponsor: Universidade do Porto (Other)
• Overall Status: Completed
• CT.gov ID: NCT05165576
• Collaborator: Centro Hospitalar De São João, E.P.E. (Other)
• Enrollment: 90
• Locations: 2
• Arms: 3
• Actual Duration (Months): 12
• Patients Per Site: 45
• Patients Per Site Per Month: 3.8

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Behavioral Problem of Child; Anxiety	Behavioral: Child-centered communication	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel assignmentParallel assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: The investigator applied the intervention. The participant and the outcomes assessors were blind as to which group participants were assigned.
• Primary Purpose: Prevention
• Official Title: The Influence of Child-centered Communication on Children's Anxiety and Use of Anesthesia for MRI
• Actual Study Start Date: Jan 1, 2020
• Actual Primary Completion Date: Jul 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Anesthesia count [30 minutes (after the Magnetic Resonance Imaging)]

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

Secondary Outcome Measures

1. 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

2. 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

Other Outcome Measures

1. Satisfaction measurement [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Hospitalar Universitário de São João	Porto		Portugal	4200-319
2	Faculty of Medicine of the University of Porto	Porto		Portugal	4200-319

Sponsors and Collaborators

• Universidade do Porto
• Centro Hospitalar De São João, E.P.E.

Investigators

• Principal Investigator: Irene P Carvalho, PhD, Faculty of Medicine of University of Porto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidade do Porto
• ClinicalTrials.gov Identifier: NCT05165576
• Other Study ID Numbers: CASTRO
• First Posted: Dec 21, 2021
• Last Update Posted: Jan 12, 2022
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Universidade do Porto: patient-centered communication; children; MRI; anesthesia; toy simulation
• Additional relevant MeSH terms: Problem Behavior

Study Results

No Results Posted as of Jan 12, 2022