Capsule Endoscopy Clinical Trial
Official title:
Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy: a Randomized Controlled Trial
Verified date | February 2024 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 31, 2023 |
Est. primary completion date | October 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: - Have indications for capsule endoscopy; - Agree to undergo capsule endoscopy; - Have normal intelligence and can communicate with the operator normally. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | Children's hospital of Fudan university | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University |
China,
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 SEGHN — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | success rate of swallowing capsule endoscopy | The success rate of children swallowing capsule endoscopy spontaneously | 48 hours | |
Secondary | HAMA anxiety score | Hamilton Anxiety Scale before capsule endoscopy examination, the lowest score means the least anxiety | 24 hours | |
Secondary | Swallowing time | Time to swallow the capsule endoscopy | 24 hours | |
Secondary | Heart rate | Heart rate of children before and during the capsule endoscopy | 48 hours | |
Secondary | Adverse effects | Adverse effects after swallowing the capsule endoscopy | 24 hours |
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