Behavioral Problem of ChildNCT05165576
Child-centered Communication and Anesthesia Use for MRI
A study testing Child-centered communication in people with Behavioral Problem of Child and Anxiety, run by Universidade do Porto at 2 sites in Portugal.
Trial 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 Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Behavioral Problem of Child, Anxiety
- What is being tested?
- Child-centered communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Jan 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages between four and 10 years old
- Having a medical request for the MRI in the hospital
- The MRI performed for the first time
Who cannot join
- Presenting cognitive, psychiatric or neurological conditions that prevented the understanding of communication
- Having any intra-body devices that impeded performance of the MRI exam
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Centro Hospitalar Universitário de São João
Porto, 4200-319
Faculty of Medicine of the University of Porto
Porto, 4200-319
About this study
Official title: 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
Read the 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).
- Conditions
- Behavioral Problem of Child, Anxiety
- Being tested
- Child-centered communication
- Keywords
- patient-centered communication, children, MRI, anesthesia, toy simulation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child-centered communicationBehavioural
The child is asked for ideas, fears and concerns regarding the magnetic resonance imaging exam and responses are tailored to these individual needs
| Study group | Role | What they receive |
|---|---|---|
| Child-centered communication | Experimental | The child's preparation for the MRI scanning is conducted using a child-centered communication type of interaction Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anesthesia count
Number of children who perform the Magnetic Resonance Imaging exam using anesthesia
Measured: 30 minutes (after the Magnetic Resonance Imaging)
Secondary outcomes (2)
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
Measured: 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
Measured: 20 minutes (before and after the child's preparation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Jan 2020
- Primary completion31 Jul 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Problem of ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Responsible party
- Sponsor
- Investigators
- Irene P Carvalho, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165576
- Sponsor's protocol ID
- CASTRO
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Child-centered Communication on Children's Anxiety and Use of Anesthesia for MRI
- ClinicalTrials.gov ID
- NCT05165576
- Acronym / sponsor ID
- CASTRO
- Conditions
- Behavioral Problem of Child, Anxiety
- Keywords
- patient-centered communication, children, MRI, anesthesia, toy simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro Hospitalar De São João, E.P.E., Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Child-centered communication | Experimental | Behavioral: Child-centered communicationThe child's preparation for the MRI scanning is conducted using a child-centered communication type of interaction |
| Magnetic Resonance Imaging (MRI) Simulation Toy | Active comparator | Behavioral: Child-centered communicationThe child's preparation for the MRI scanning is conducted through provision of general information about the MRI exam simulated with an MRI toy |
| 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 |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages between four and 10 years old
- Having a medical request for the MRI in the hospital
- The MRI performed for the first time
Key exclusion criteria (2 listed)
- Presenting cognitive, psychiatric or neurological conditions that prevented the understanding of communication
- Having any intra-body devices that impeded performance of the MRI exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Child-centered communicationThe child is asked for ideas, fears and concerns regarding the magnetic resonance imaging exam and responses are tailored to these individual needs | Behavioural | Child-centered communication, Magnetic Resonance Imaging (MRI) Simulation Toy |
Primary outcome
Anesthesia count
Time frame: 30 minutes (after the Magnetic Resonance Imaging)
Number of children who perform the Magnetic Resonance Imaging exam using anesthesia
2 secondary outcomes
Change in self-reported anxiety
Time frame: 20 minutes (before and after the child's preparation)
Change in heart rate frequency
Time frame: 20 minutes (before and after the child's preparation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene P Carvalho, PhD principal investigator
Universidade do Porto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child-centered communication in people with Behavioral Problem of Child and Anxiety, run by Universidade do Porto at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anesthesia count (time frame: 30 minutes (after the Magnetic Resonance Imaging)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.