Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy

Capsule Endoscopy Clinical Trial

Official title:

Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605536
• Other study ID #: CE_swallowing
• Status: Completed
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Capsule Endoscopy

Intervention

Other:
• animation videos
watch animation videos about capsule endoscopy
• explanation about endoscopy endoscopy
Give general explanations about endoscopy endoscopy

Locations

Country	Name	City	State
China	Children's hospital of Fudan university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

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

Outcome

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