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

NCT04334733 | Completed

• 1 other identifier: 2018/13 Osmangazi University
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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).

Conditions

Anxiety; Child, Only; Echocardiography

Keywords

Child; Anxiety; Echocardiography; Cartoon; Kaleidoscope

Outcome Measures

Primary Outcomes (1)

• 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

  1 minute

Study Arms (4)

Cartoon group

EXPERIMENTAL

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

Other: Cartoon group

Kaleidoscope group

EXPERIMENTAL

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

Other: Kaleidoscope group

Cartoon+Kaleidoscope group

EXPERIMENTAL

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

Control group

EXPERIMENTAL

No intervention was made to children in the control group

Other: Cartoon group; Other: Kaleidoscope group; Other: Cartoon+Kaleidoscope group

Interventions

Cartoon group OTHER

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

Cartoon group; Control group

Kaleidoscope group OTHER

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

Control group; Kaleidoscope group

Cartoon+Kaleidoscope group OTHER

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.

Cartoon+Kaleidoscope group; Control group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Gender Eligibility Details: Female,Male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• chronic disease
• mental disease
• neurological disease

Sponsors & Collaborators

• Selcuk University: lead
• Eskisehir Osmangazi University: collaborator

Study Sites (1)

Selçuk University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Research assistant

Model Details: 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)".

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: October 6, 2018
• Primary Completion: February 1, 2019
• Study Completion: December 25, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)