NCT04127097

Brief Summary

Objective: The study was carried out in a randomized controlled manner to determine the effect of the watching cartoons on the fear and anxiety levels of children during treatment. Method: The population of the study consisted of children aged 5-10 years who were brought to a state hospital in a southeastern province for blood collection. A total of 92 children, 43 of whom were in the cartoon group and 49 of which were in the control group, were included in the study. Research findings; Data Form was obtained by using Child Anxiety Scale and Child Fear Scale. The children in the cartoon group were shown the cartoons they wanted during the treatment. Anxiety and fear levels before and during the blood collection were evaluated in the cartoon and control groups. The anxiety level of the children was evaluated according to their own expressions, and the level of fear was evaluated independently according to both the children's own statements and the observers' statements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2019

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 12, 2019

Last Update Submit

October 11, 2020

Conditions

Keywords

anxietyfearnursing

Outcome Measures

Primary Outcomes (2)

  • Children Fear Scale

    The scale is used to evaluate the anxiety level of 4-10 year-old children. Five images of cartoon faces are used in the scale. Anxiety level is evaluated with numbers between "0" and "4". While "0" point refers to "no anxiety", "4" points refer to "severe anxiety"

    1 minute

  • Children Anxiety Scale

    it is similar to a thermometer with a bulb at the bottom and horizontal lines at upwardly spaced intervals. In the scale for children aged four to ten years, the child is asked to indicate that he / she feels "now için to measure State anxiety. Score can vary from 0 to 10

    1 minute

Study Arms (2)

cartoon group

EXPERIMENTAL
Other: cartoon group

control group

NO INTERVENTION

Interventions

The children in the groups were distracted by watching cartoon 2 minutes before treatment, until the process was over

cartoon group

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • being healthy
  • ability to express himself/herself verbally
  • having no visual or auditory problems

You may not qualify if:

  • mental disease
  • neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batman obstetrics and pediatric hospital

Batman, 72060, 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
Principal Investigator

Study Record Dates

First Submitted

October 12, 2019

First Posted

October 15, 2019

Study Start

September 30, 2019

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

October 14, 2020

Record last verified: 2020-10

Locations