Using a Cartoon Questionnaire to Improve Consent of Children: A Randomized Controlled Trial

Using a Cartoon Questionnaire to Improve Consent of Children

Sponsors

Lead sponsor: Shanghai Jiao Tong University School of Medicine

Source Shanghai Jiao Tong University School of Medicine
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date November 26, 2019
Completion Date October 30, 2020
Primary Completion Date August 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
correction rates 1 hour after completing the questionnaire
attitudes toward biospecific nonspecimen specimens 1 hour after completing the questionnaire
Enrollment 300
Condition
Intervention

Intervention type: Other

Intervention name: audio and animated cartoon questionnaire

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

Eligibility

Criteria:

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

Gender: All

Minimum age: 7 Years

Maximum age: 18 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Shijian Liu Principal Investigator Shanghai Children's Medical Center
Overall Contact

Last name: Shijian Liu

Phone: 86-21-38625637

Email: [email protected]

Location
facility status contact
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine Recruiting Shijian Liu, Ph.D 21-38625637 [email protected]
Location Countries

China

Verification Date

November 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Shanghai Jiao Tong University School of Medicine

Investigator full name: Sijia Gu

Investigator title: Clinical Professor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: audio and animated cartoon questionnaire group

Arm group type: Experimental

Description: After a brief introduction to our survey, participants(children) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with audio and animated cartoon questionnaire. The animation was an 8-minute cartoon video divided into different parts according to different questions. The first part of the animation was the introduction of biospecific nonspecimen specimen and our survey, while the other parts showed the content of the questionnaire about donating biospecific nonspecimen specimen in a vivid way. The background music built a relaxed and pleasant atmosphere, and some cartoon pictures were made into question options to simplify the understanding and data analysis.

Arm group label: text questionnaire group

Arm group type: No Intervention

Description: After a brief introduction to our survey, participants(children) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with text questionnaire.

Arm group label: Parent group

Arm group type: Other

Description: After a brief introduction to our survey, participants(parent) were asked to complete a questionnaire on a professional platform named 'Wen juan xing app'(www.wjx.cn) with text questionnaire.

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov