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Clinical Trials/NCT04605536
NCT04605536
Completed
Not Applicable

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

Children's Hospital of Fudan University1 site in 1 country200 target enrollmentOctober 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Capsule Endoscopy
Sponsor
Children's Hospital of Fudan University
Enrollment
200
Locations
1
Primary Endpoint
success rate of swallowing capsule endoscopy
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 22, 2020
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ying HUANG

Director

Children's Hospital of Fudan University

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

Outcomes

Primary Outcomes

success rate of swallowing capsule endoscopy

Time Frame: 48 hours

The success rate of children swallowing capsule endoscopy spontaneously

Secondary Outcomes

  • Heart rate(48 hours)
  • Adverse effects(24 hours)
  • HAMA anxiety score(24 hours)
  • Swallowing time(24 hours)

Study Sites (1)

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