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

NCT05861232 | Unknown

• 1 other identifier: B.30.2.ATA.0.01.11/285
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Inhalation Therapy; Complications

Outcome Measures

Primary Outcomes (1)

• 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).

  12 MONTHS

Secondary Outcomes (1)

• Facial Expressions Rating Scale

  12 MONTHS

Study Arms (2)

Experimental

EXPERIMENTAL

informative animation, anxiety and fear

Behavioral: Behavioral

No Intervention

NO INTERVENTION

Control not anxiety and fear

Interventions

Behavioral BEHAVIORAL

fear and anxiety during inhalation therapy

Experimental

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• The child has a chronic illness
• The child has a neurological or mental impairment
• The child is visually impaired

Sponsors & Collaborators

• Mukader Kaya: lead

Study Sites (1)

Ataturk University Faculty of Nursing

Erzurum, Center, 25240, Turkey (Türkiye)

RECRUITING

Study Officials

• Mukader KAYA, graduate student

  ATATÜRK UNİVERSITY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mukader Kaya, graduate student

CONTACT

+905455853628; kader123300@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: study director

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: May 16, 2023
• Study Start: July 7, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)