- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06071390
The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure
October 4, 2023 updated by: Merve Koyun, Ondokuz Mayıs University
The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure: A Randomized Controlled Study
The aim of this study was to evaluate watching video about procedure on reduce anxiety and fear in children before the endoscopy.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Atakum
-
Samsun, Atakum, Turkey, 55139
- Ondokuz Mayıs University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changing the anxiety
Time Frame: '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.
|
'Before watching video' and 'After watching video, within 5 minutes'
|
|
changing the fear
Time Frame: '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.
|
'Before watching video' and 'After Watching Video, within 5 minutes'
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Arican, Ş., Yücel, A., Yılmaz, R., Hacıbeyoğlu, 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2023
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
September 27, 2023
First Submitted That Met QC Criteria
October 4, 2023
First Posted (Actual)
October 6, 2023
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 4, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Endoscopy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
other researchers may view the study once it is published.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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