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

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Completed
CT.gov ID
NCT06071390
Collaborator
(none)
46
1
2
7
6.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Animated- assisted video
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study is a randomized controlled experimental study.The study is a randomized controlled experimental study.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure: A Randomized Controlled Study
Actual Study Start Date :
Jan 1, 2023
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Children watching animated- assisted video before endoscopy procedure

Inclusion criteria were children and mothers who voluntarily participated, who were aged 6-12 years, who know Turkish, and who do not have a vision or mental problem at a level to watch the image.

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.

No Intervention: Children not watching animated- assisted video before endoscopy procedure

Exclusion criteria were children and mothers who not voluntarily participated, who were not aged 6-12 years, who don't know Turkish, and who have a vision or mental problem at a level to watch the image.

Outcome Measures

Primary Outcome Measures

  1. changing the anxiety ['Before watching video' and 'After watching video, within 5 minutes']

    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.

  2. changing the fear ['Before watching video' and 'After Watching Video, within 5 minutes']

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ondokuz Mayıs University Samsun Atakum Turkey 55139

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Merve Koyun, Principal Investigator, Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT06071390
Other Study ID Numbers:
  • Endoscopy
First Posted:
Oct 6, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2023