Clinical trial NCT04605536: Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy
Official title: Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capsule Endoscopy
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: success rate of swallowing capsule endoscopy
timeFrame: 48 hours
Secondary outcomes:
measure: HAMA anxiety score
timeFrame: 24 hours
measure: Swallowing time
timeFrame: 24 hours
measure: Heart rate
timeFrame: 48 hours
measure: Adverse effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
Study officials:
References:
citation: 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.