EndoscopyNCT06071390
The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure
A study testing Animated- assisted video in people with Endoscopy and Animation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate watching video about procedure on reduce anxiety and fear in children before the endoscopy. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- What is being tested?
- Animated- assisted video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Atakum, 55139
About this study
Official title: 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.
Read the 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.
- Being tested
- Animated- assisted video
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animated- assisted videoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Children watching animated- assisted video before endoscopy procedure | Experimental | 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. Receives: Behavioral: Animated- assisted video |
| Children not watching animated- assisted video before endoscopy procedure | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 'Before watching video' and 'After watching video, within 5 minutes'
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.
Measured: 'Before watching video' and 'After Watching Video, within 5 minutes'
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Koyun, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071390
- Sponsor's protocol ID
- Endoscopy
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: other researchers may view the study once it is published.
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.
PubMed 32056813Arican, 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.
PubMed 33331038
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06071390
- Acronym / sponsor ID
- Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to evaluate watching video about procedure on reduce anxiety and fear in children before the endoscopy.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Children watching animated- assisted video before endoscopy procedure | Experimental | Behavioral: Animated- assisted videoInclusion 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. |
| Children not watching animated- assisted video before endoscopy procedure | No intervention | –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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animated- assisted videoFor 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. | Behavioural | Children watching animated- assisted video before endoscopy procedure |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 32056813Alvarez-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.
- BackgroundArican, 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.
- Background: PubMed 33331038Camur 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.
- Individual participant dataSharing planned: No. other researchers may view the study once it is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animated- assisted video in people with Endoscopy and Animation, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changing the anxiety (time frame: 'Before watching video' and 'After watching video, within 5 minutes'). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071390, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.