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

Primary Purpose

Anxiety, Child, Only, Echocardiography

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Cartoon group
Kaleidoscope group
Cartoon+Kaleidoscope group
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Child, Anxiety, Echocardiography, Cartoon, Kaleidoscope

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Selçuk University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cartoon group

Kaleidoscope group

Cartoon+Kaleidoscope group

Control group

Arm Description

The children in the groups were distracted by watching cartoon 5 minutes before echocardiography.

The children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over.

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.

No intervention was made to children in the control group

Outcomes

Primary Outcome Measures

Children Fear Scale
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

Secondary Outcome Measures

Full Information

First Posted
April 1, 2020
Last Updated
April 3, 2020
Sponsor
Selcuk University
Collaborators
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04334733
Brief Title
The Impact of Preprocedural Animation About Echocardiography Display and Kaleidoscope Display on Anxiety in Children
Official Title
The Impact of Preprocedural Informative Animation Display About Echocardiography and Intraprocedural Kaleidoscope Display on Anxiety in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 6, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
December 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University
Collaborators
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Child, Only, Echocardiography
Keywords
Child, Anxiety, Echocardiography, Cartoon, Kaleidoscope

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This randomized controlled experimental study was carried out with 164 children in the 5-12 age group in the pediatric echocardiography unit of a Training and Research Hospital between February 2019 and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Cartoon Group (n=41), Kaleidoscope Group (n=41), Cartoon+Kaleidoscope Group (n=41), Control group (Routine echocardiography) (41) . The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)".
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cartoon group
Arm Type
Experimental
Arm Description
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography.
Arm Title
Kaleidoscope group
Arm Type
Experimental
Arm Description
The children in the groups were distracted by kaleidoscope during the echocardiography process, until the process was over.
Arm Title
Cartoon+Kaleidoscope group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Experimental
Arm Description
No intervention was made to children in the control group
Intervention Type
Other
Intervention Name(s)
Cartoon group
Intervention Description
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process.
Intervention Type
Other
Intervention Name(s)
Kaleidoscope group
Intervention Description
The children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
Intervention Type
Other
Intervention Name(s)
Cartoon+Kaleidoscope group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Children Fear Scale
Description
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
Time Frame
1 minute

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female,Male
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Selçuk University
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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