Capsule EndoscopyNCT04605536
Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy
A study testing animation videos and explanation about endoscopy endoscopy in people with Capsule Endoscopy, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
There are a variety of strategies that can be used for education to improve patients' awareness of the electronic capsule endoscopy process at present. The animated images in the animation videos are interesting as the explanations are simple and easy to understand. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Capsule Endoscopy
- What is being tested?
- animation videos and explanation about endoscopy endoscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2020to 31 Oct 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Have indications for capsule endoscopy;
- Agree to undergo capsule endoscopy;
- Have normal intelligence and can communicate with the operator normally.
Who cannot join
- Contraindications for capsule endoscopy;
- Previous experience of capsule endoscopy;
- Allergic to polymer materials;
- Persons with mental retardation;
- Those who cannot communicate normally due to diseases or emotions;
- A HAMA scale of 21 or above, which indicates severe anxiety, before the examination
Trial locations and contacts
1 site in 1 country.
China1 site
Children's hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy: a Randomized Controlled Trial
There are a variety of strategies that can be used for education to improve patients' awareness of the electronic capsule endoscopy process at present. The animated images in the animation videos are interesting as the explanations are simple and easy to understand. It is one of the best choices for children's education. A number of studies have shown that animated videos can increase the awareness rate of children's related knowledge, reduce anxiety, improve children's compliance with examinations and operations, and achieve good clinical results. Effective information transmission to children and their family members can increase the children's cognition and may affect the children's compliance with swallowing capsules and the success rate of autonomous swallowing, thereby reducing the time for swallowing capsule endoscopes and increasing capsule endoscopes Complete small bowel examination completion rate. This study aimed to evaluate the impact of animated video education on the success rate of children swallowing capsule endoscopy and analyze the related factors that affect the time for children to swallow capsules autonomously.
- Conditions
- Capsule Endoscopy
- Being tested
- animation videos, explanation about endoscopy endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
animation videosOther
watch animation videos about capsule endoscopy
explanation about endoscopy endoscopyOther
Give general explanations about endoscopy endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Give explanations about conventional capsule endoscopy and watch animation videos Receives: Other: animation videos; Other: explanation about endoscopy endoscopy |
| Control | Other | Give explanations about conventional capsule endoscopy Receives: Other: explanation about endoscopy endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of swallowing capsule endoscopy
The success rate of children swallowing capsule endoscopy spontaneously
Measured: 48 hours
Secondary outcomes (4)
HAMA anxiety score
Hamilton Anxiety Scale before capsule endoscopy examination, the lowest score means the least anxiety
Measured: 24 hours
Swallowing time
Time to swallow the capsule endoscopy
Measured: 24 hours
Heart rate
Heart rate of children before and during the capsule endoscopy
Measured: 48 hours
Adverse effects
Adverse effects after swallowing the capsule endoscopy
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start22 Oct 2020
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Capsule EndoscopyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605536
- Sponsor's protocol ID
- CE_swallowing
- Status last verified
- Feb 2024
- First submitted
- 22 Oct 2020
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arguelles-Arias F, Donat E, Fernandez-Urien I, Alberca F, Arguelles-Martin F, Martinez MJ, Molina M, Varea V, Herrerias-Gutierrez JM, Ribes-Koninckx C. Guideline for wireless capsule endoscopy in children and adolescents: A consensus document by the SEGHNP (Spanish Society for Pediatric Gastroenterology, Hepatology, and Nutrition) and the SEPD (Spanish Society for Digestive Diseases). Rev Esp Enferm Dig. 2015 Dec;107(12):714-31. doi: 10.17235/reed.2015.3921/2015.
PubMed 26671584
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04605536
- Acronym / sponsor ID
- CE_swallowing
- Conditions
- Capsule Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 28 Oct 2020 (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.
There are a variety of strategies that can be used for education to improve patients' awareness of the electronic capsule endoscopy process at present. The animated images in the animation videos are interesting as the explanations are simple and easy to understand. It is one of the best choices for children's education. A number of studies have shown that animated videos can increase the awareness rate of children's related knowledge, reduce anxiety, improve children's compliance with examinations and operations, and achieve good clinical results. Effective information transmission to children and their family members can increase the children's cognition and may affect the children's compliance with swallowing capsules and the success rate of autonomous swallowing, thereby reducing the time for swallowing capsule endoscopes and increasing capsule endoscopes Complete small bowel examination completion rate. This study aimed to evaluate the impact of animated video education on the success rate of children swallowing capsule endoscopy and analyze the related factors that affect the time for children to swallow capsules autonomously.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: animation videos, Other: explanation about endoscopy endoscopyGive explanations about conventional capsule endoscopy and watch animation videos |
| Control | Other | Other: explanation about endoscopy endoscopyGive explanations about conventional capsule endoscopy |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Have indications for capsule endoscopy;
- Agree to undergo capsule endoscopy;
- Have normal intelligence and can communicate with the operator normally.
Key exclusion criteria (6 listed)
- Contraindications for capsule endoscopy;
- Previous experience of capsule endoscopy;
- Allergic to polymer materials;
- Persons with mental retardation;
- Those who cannot communicate normally due to diseases or emotions;
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 |
|---|---|---|
| animation videoswatch animation videos about capsule endoscopy | Other | Intervention |
| explanation about endoscopy endoscopyGive general explanations about endoscopy endoscopy | Other | Control, Intervention |
Primary outcome
success rate of swallowing capsule endoscopy
Time frame: 48 hours
The success rate of children swallowing capsule endoscopy spontaneously
4 secondary outcomes
HAMA anxiety score
Time frame: 24 hours
Swallowing time
Time frame: 24 hours
Heart rate
Time frame: 48 hours
Adverse effects
Time frame: 24 hours
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 7 Feb 2024.
- Results publication: PubMed 26671584Arguelles-Arias F, Donat E, Fernandez-Urien I, Alberca F, Arguelles-Martin F, Martinez MJ, Molina M, Varea V, Herrerias-Gutierrez JM, Ribes-Koninckx C. Guideline for wireless capsule endoscopy in children and adolescents: A consensus document by the SEGHNP (Spanish Society for Pediatric Gastroenterology, Hepatology, and Nutrition) and the SEPD (Spanish Society for Digestive Diseases). Rev Esp Enferm Dig. 2015 Dec;107(12):714-31. doi: 10.17235/reed.2015.3921/2015.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Esophageal and Gastric Diseases With Robotically Controlled Magnetic Capsule Endoscopy
Video Capsule Endoscopy, Esophageal Diseases
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 animation videos and explanation about endoscopy endoscopy in people with Capsule Endoscopy, run by Children's Hospital of Fudan University at 1 site in China.
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 3 inclusion and 6 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 7 Feb 2024. 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 China. 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?
success rate of swallowing capsule endoscopy (time frame: 48 hours). 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 NCT04605536, which also lists 1 linked publication.
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 7 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.