Clinical trial NCT04334733: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Child, Only
Echocardiography
Keywords: Child
Anxiety
Echocardiography
Cartoon
Kaleidoscope
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: Eskisehir Osmangazi University
First posted: 2020-04-06
Enrollment: 164
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)".
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Children Fear Scale
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selçuk University
Study officials:
References: