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