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The Effect of Watching Informative Animation on Fear and Anxiety in Children

Primary Purpose

Inhalation Therapy; Complications

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Behavioral
Sponsored by
Mukader Kaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inhalation Therapy; Complications

Eligibility Criteria

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

Inclusion Criteria: The child is 7-12 years of age The family's willingness to participate in the study The child's willingness to participate in the study The child does not have a chronic disease Exclusion Criteria: The child has a chronic illness The child has a neurological or mental impairment The child is visually impaired

Sites / Locations

  • Ataturk University Faculty of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

No Intervention

Arm Description

informative animation, anxiety and fear

Control not anxiety and fear

Outcomes

Primary Outcome Measures

Child Fear Scale (CFS)
The Child Fear Scale was developed by McMurty et al. in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 Likert type scale showing five different faces, ranging from neutral (0 = no concern at all) to fearful (4 = severe anxiety).

Secondary Outcome Measures

Facial Expressions Rating Scale
This visual facial scale is a practical method to assess the level of anxiety within a situation. There are six facial expressions, ranging from very happy to very unhappy, and children are asked to choose the one that comes closest to how they feel at that moment. The most positive face is scored as '0' and the most negative face is scored as '5'.

Full Information

First Posted
January 11, 2023
Last Updated
May 31, 2023
Sponsor
Mukader Kaya
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1. Study Identification

Unique Protocol Identification Number
NCT05861232
Brief Title
The Effect of Watching Informative Animation on Fear and Anxiety in Children
Official Title
THE EFFECT OF INFORMATIVE ANIMATION WATCHING ON ANXIETY AND FEAR DURING INHALATION THERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
July 7, 2023 (Anticipated)
Study Completion Date
July 7, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mukader Kaya

4. Oversight

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

5. Study Description

Brief Summary
The aim of this project was to determine the effect of showing informative animations to children on anxiety and fear during inhalation therapy. This project is a randomized controlled trial. The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023. The sample of the study will consist of children and their parents who present to the clinic on the dates determined, who are willing to participate in the study, and meet the inclusion criteria. Probability sampling will be used to select the sample. ''Introductory Information Form'', ''Child Fear Scale'', ''Facial Expression Rating Scale'' and ''Informative Animation'' will be used for data collection.
Detailed Description
Type of Study: The study was designed as a randomized controlled experimental study. Place and Time of Research: The study will be conducted at Atatürk University Research Hospital Pediatric Emergency Department between July 2022 and July 2023. Population and Sample of the Study: The population of the study will consist of children aged 7-12 years who apply to the Pediatric Emergency Department of Atatürk University Research Hospital between July 2022 and July 2023.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Therapy; Complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
informative animation, anxiety and fear
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
Control not anxiety and fear
Intervention Type
Behavioral
Intervention Name(s)
Behavioral
Intervention Description
fear and anxiety during inhalation therapy
Primary Outcome Measure Information:
Title
Child Fear Scale (CFS)
Description
The Child Fear Scale was developed by McMurty et al. in 2011 to measure fear in children undergoing painful medical procedures. The Child Fear Scale is a 0-4 Likert type scale showing five different faces, ranging from neutral (0 = no concern at all) to fearful (4 = severe anxiety).
Time Frame
12 MONTHS
Secondary Outcome Measure Information:
Title
Facial Expressions Rating Scale
Description
This visual facial scale is a practical method to assess the level of anxiety within a situation. There are six facial expressions, ranging from very happy to very unhappy, and children are asked to choose the one that comes closest to how they feel at that moment. The most positive face is scored as '0' and the most negative face is scored as '5'.
Time Frame
12 MONTHS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: The child is 7-12 years of age The family's willingness to participate in the study The child's willingness to participate in the study The child does not have a chronic disease Exclusion Criteria: The child has a chronic illness The child has a neurological or mental impairment The child is visually impaired
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mukader Kaya, graduate student
Phone
+905455853628
Email
kader123300@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mukader KAYA, graduate student
Organizational Affiliation
ATATÜRK UNİVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ataturk University Faculty of Nursing
City
Erzurum
State/Province
Center
ZIP/Postal Code
25240
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mukader KAYA, WORK DIRECTOR
Phone
+905455853628
Email
kader123300@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
THE ARTICLE IS INTENDED TO BE SHARED AFTER PUBLICATION.

Learn more about this trial

The Effect of Watching Informative Animation on Fear and Anxiety in Children

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