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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334733
• Other study ID #: 2018/13 Osmangazi University
• Status: Completed
• Phase: N/A
• Start date: October 6, 2018
• Est. completion date: December 25, 2019

Study information

• Verified date: April 2020
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 25, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Child, Only
• Echocardiography

Intervention

Other:
• Cartoon group
The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process.
• Kaleidoscope group
The children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
• 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.

Locations

Country	Name	City	State
Turkey	Selçuk University	Konya

Sponsors (2)

Lead Sponsor	Collaborator
Selcuk University	Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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