The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure

Anxiety Clinical Trial

Official title:

The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06071390
• Other study ID #: Endoscopy
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to evaluate watching video about procedure on reduce anxiety and fear in children before the endoscopy.

Description:

Being admitted to a hospital is an inherently stressful event for both children and their parents, regardless of the reason In such a context where children experience multifaceted effects, it becomes imperative to ensure that their hospital experience is as positive as possible. Hospitalized children often undergo medical procedures such as blood sampling, venipuncture, invasive drug administration, lumbar puncture, and intrathecal drug administration. These interventions, whether diagnostic or therapeutic, are sources of fear and anxiety for them. With a surge in gastrointestinal system disorders in children, the use of endoscopy, both as a diagnostic and therapeutic tool, has become more prevalent. Pediatric nurses play a pivotal role in alleviating the fear and anxiety experienced by children and their families during medical procedures, ensuring a smoother adjustment to the process. Prior research indicates that children's fear and anxiety levels significantly decrease, and parental satisfaction rises when children are informed about impending medical procedures. Moreover, providing pre-procedure information has been linked to heightened treatment compliance, expedited recovery post-procedure, and a reduced reliance on analgesics. While tailored educational programs are highly effective in conveying information about medical procedures or diseases to children, their elevated cost restricts widespread implementation. Traditional, cost-effective teaching strategies such as oral presentations, brochures, and booklets, although tailored for school-age children, haven't demonstrated consistent efficacy in enhancing clinical results. It has been noted that insufficient information provision can make children reliant on parents for clarification, with most procedural details tailored to parental understanding. In response, evidence-based initiatives have been introduced to enhance educational quality, boost patient clinical outcomes, and ensure cost-effectiveness. Given children's developmental stage, diverse educational techniques have been employed to prepare them for medical procedures, including endoscopy. An emerging method involves utilizing cartoons, which, when effectively employed, blend entertainment with instruction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children and mothers who voluntarily participated,

• who were aged 6-12 years,

• who know Turkish,

• who do not have a vision or mental problem at a level to watch the image.

Exclusion Criteria:

• children and mothers who not voluntarily participated,

• who were not aged 6-12 years,

• who don't know Turkish,

• who have a vision or mental problem at a level to watch the image.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Child
• Endoscopy
• Fear

Intervention

Behavioral:
• Animated- assisted video
For the experimental group, 15 minutes prior to the endoscopy, the researcher provided insight into the procedure by showing them a 3-minute animated video titled "Endocan." This video, crafted by Köse in 2019 for his doctoral dissertation, offers a succinct overview of the endoscopy procedure.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Alvarez-Garcia C, Yaban ZS. The effects of preoperative guided imagery interventions on preoperative anxiety and postoperative pain: A meta-analysis. Complement Ther Clin Pract. 2020 Feb;38:101077. doi: 10.1016/j.ctcp.2019.101077. Epub 2019 Dec 4. — View Citation

Arican, S., Yücel, A., Yilmaz, R., Hacibeyoglu, G., Yusifov, M., Yüce, S., Topal, A.(2020). Anxiety level and risk factors among pediatric patients in endoscopic procedures outside the operating room: A cross-sectional study. J Surg Med, 4(8), 693-697.

Camur Z, Sarikaya Karabudak S. The effect of parental participation in the care of hospitalized children on parent satisfaction and parent and child anxiety: Randomized controlled trial. Int J Nurs Pract. 2021 Oct;27(5):e12910. doi: 10.1111/ijn.12910. Epub 2020 Dec 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changing the anxiety	Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.	'Before watching video' and 'After watching video, within 5 minutes'
Primary	changing the fear	The Children's Fear Scale (CFS) was developed by Chambers et al. in 2011. It was adapted into Turkish by Gerceker et al. in 2018. It comprises five facial expressions ranging from neutral to extreme fear. Both researchers and family members can use the CFS to measure fear and anxiety in children before and during procedures. This scale provides scores ranging from 0-4. As the score increases, the level of fear increases.	'Before watching video' and 'After Watching Video, within 5 minutes'