NCT04605536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

October 22, 2020

Last Update Submit

February 6, 2024

Conditions

Capsule Endoscopy

Outcome Measures

Primary Outcomes (1)

  • success rate of swallowing capsule endoscopy

    The success rate of children swallowing capsule endoscopy spontaneously

    48 hours

Secondary Outcomes (4)

  • HAMA anxiety score

    24 hours

  • Swallowing time

    24 hours

  • Heart rate

    48 hours

  • Adverse effects

    24 hours

Study Arms (2)

Intervention

OTHER

Give explanations about conventional capsule endoscopy and watch animation videos

Other: animation videosOther: explanation about endoscopy endoscopy

Control

OTHER

Give explanations about conventional capsule endoscopy

Other: explanation about endoscopy endoscopy

Interventions

animation videosOTHER

watch animation videos about capsule endoscopy

Intervention
explanation about endoscopy endoscopyOTHER

Give general explanations about endoscopy endoscopy

ControlIntervention

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Have indications for capsule endoscopy;
  • Agree to undergo capsule endoscopy;
  • Have normal intelligence and can communicate with the operator normally.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

Location

Related 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 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.

    PMID: 26671584RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 22, 2020

First Posted

October 28, 2020

Study Start

October 22, 2020

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)