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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04179240
Other study ID # SCMCIRB-K2016069
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 26, 2019
Est. completion date October 30, 2020

Study information

Verified date November 2019
Source Shanghai Jiao Tong University School of Medicine
Contact Shijian Liu
Phone 86-21-38625637
Email liushijian@scmc.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, a prospective, multicenter, randomized, and controlled trial will be performed to evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation.


Description:

In this study, we will evaluate the effectiveness of an audio and animated cartoon questionnaire (AACQ) at improving child understanding and enhancing a positive attitude to participate in biospecific nonspecimen specimen donation. A prospective, multicenter, randomized, and controlled trial will be performed at some hospitals in China. Three hundred children will be randomly asked to participate in our survey to investigate the participants' willingness and attitudes for donating biospecific nonspecimen specimen.The participants will be randomly allocated to the AACQ group and the text questionnaire (TQ) group. A separate knowledge test to assess the amount of knowledge acquired is included in the questionnaires. Additionally, participants' demographic data and basic information will be also collected. In our present study, we aim to test whether an audio and animated cartoon could help the child to understand the information about our research of biospecific nonspecimen specimen donation, reduce differences in their understanding, and use that information to make an appropriate decision for themselves. Meanwhile, we will exam factors that may influence a Chinese child's willingness to donate biospecific nonspecimen specimen before pediatric surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date October 30, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 7 Years to 18 Years
Eligibility Inclusion Criteria:

- Patients without obvious communication difficulties in the pediatric surgery wards were invited to participate in this survey.

Exclusion Criteria:

- Patients with obvious communication difficulties

Study Design


Related Conditions & MeSH terms


Intervention

Other:
audio and animated cartoon questionnaire
participants were asked to complete a questionnaire audio and animated cartoon on a platform

Locations

Country Name City State
China Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary correction rates A knowledge test to assess the acquired comprehension of biospecific nonspecimen specimens donated was given at the end of the questionnaire 1 hour after completing the questionnaire
Primary attitudes toward biospecific nonspecimen specimens children's attitudes toward whether they would like to donate a particular kind of biospecific nonspecimen specimens 1 hour after completing the questionnaire
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