The Impact of Preprocedural Animation About Echocardiography Display and Kaleidoscope Display on Anxiety in Children

April 3, 2020 updated by: Birsel Molu, Selcuk University

The Impact of Preprocedural Informative Animation Display About Echocardiography and Intraprocedural Kaleidoscope Display on Anxiety in Children

Objective: The study was conducted for the purpose of determining the effect of making children aged 5 to 12 years watch a cartoon about echocardiography (ECO) procedure before the procedure and kaleidoscope during the procedure on their anxiety.

Material and Method: It is a randomized controlled study. The study was completed with a total of 164 children who came to have an ECO and met the sample selection criteria. There were four groups in the study which were as follows; the group that was made watch a cartoon about the procedure before the procedure, the group that was made watch a kaleidoscope during the procedure, the group that was made watch a cartoon about the procedure before the procedure and a kaleidoscope during the procedure and the control group in which routine applications of clinic were carried out.

Results: At the end of the study, it was determined that anxiety scores of the cartoon group, cartoon+kaleidoscope group and the kaleidoscope group were lower during the procedure than before the procedure (p<0,001). In the control group, it was determined that there was no significant difference between the anxiety scores before and during the procedure (p>0,05).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study was conducted for the purpose of determining the effect of making children aged 5 to 12 years watch a cartoon about echocardiography (ECO) procedure before the procedure and kaleidoscope during the procedure on their anxiety. It is a randomized controlled study. The study was conducted in the Pediatric Cardiology Polyclinic of Afyon Kocatepe University Ahmet Necdet Sezer Research and Application Hospital in the Province of Afyonkarahisar between 6 November 2018-1 February 2019. The study was completed with a total of 164 children who came to have an ECO and met the sample selection criteria. There were four groups in the study which were as follows; the group that was made watch a cartoon about the procedure before the procedure, the group that was made watch a kaleidoscope during the procedure, the group that was made watch a cartoon about the procedure before the procedure and a kaleidoscope during the procedure and the control group in which routine applications of clinic were carried out. Samples were assigned to the groups using permutation block randomization method. In order to collect data, an Introductory Information Form and the Child Fear Scale were used. The data acquired from the study were evaluated using the IBM SPSS Statistics 24 (Statistical Package for Social Sciences) package software. In our study, the experimental and control group children were found to be similar in terms of introductory characteristics (age, gender, educational level, family structure, number of children in family, illness and hospital experiences, information about ECO). At the end of the study, it was determined that anxiety scores of the cartoon group, cartoon+kaleidoscope group and the kaleidoscope group were lower during the procedure than before the procedure (p<0,001). In the control group, it was determined that there was no significant difference between the anxiety scores before and during the procedure (p>0,05).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • being healthy
  • ability to express himself/herself verbally
  • no sedation taken in the last eight hours
  • having no visual or auditory problems
  • Ecocardiography process is to be held for the first time

Exclusion Criteria:

  • chronic disease
  • mental disease
  • neurological disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cartoon group
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography.
Other: Cartoon group
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process.
Experimental: Kaleidoscope group
The children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over.
Other: Kaleidoscope group
The children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
Experimental: Cartoon+Kaleidoscope group
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography and the children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over.
Other: Cartoon+Kaleidoscope group
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process and then the children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
Experimental: Control group
No intervention was made to children in the control group
Other: Cartoon group
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process.
Other: Kaleidoscope group
The children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
Other: Cartoon+Kaleidoscope group
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process and then the children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Children Fear Scale
Time Frame: 1 minute
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural anxiety were evaluated
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/13 Osmangazi University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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