Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy
February 6, 2024 updated by: Ying HUANG, Children's Hospital of Fudan University
Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201102
- Children's Hospital of Fudan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention
Give explanations about conventional capsule endoscopy and watch animation videos
|
watch animation videos about capsule endoscopy
Give general explanations about endoscopy endoscopy
|
|
Other: Control
Give explanations about conventional capsule endoscopy
|
Give general explanations about endoscopy endoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
success rate of swallowing capsule endoscopy
Time Frame: 48 hours
|
The success rate of children swallowing capsule endoscopy spontaneously
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Swallowing time
Time Frame: 24 hours
|
Time to swallow the capsule endoscopy
|
24 hours
|
|
Heart rate
Time Frame: 48 hours
|
Heart rate of children before and during the capsule endoscopy
|
48 hours
|
|
Adverse effects
Time Frame: 24 hours
|
Adverse effects after swallowing the capsule endoscopy
|
24 hours
|
|
HAMA anxiety score
Time Frame: 24 hours
|
Hamilton Anxiety Scale before capsule endoscopy examination, the lowest score means the least anxiety
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 22, 2020
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
October 22, 2020
First Submitted That Met QC Criteria
October 22, 2020
First Posted (Actual)
October 28, 2020
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CE_swallowing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.