Using a Cartoon Questionnaire to Improve Consent of Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Child Development, Ethics, Narrative

Intervention / Treatment
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* Other: audio and animated cartoon questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: audio and animated cartoon questionnaire group<br>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. | Other: audio and animated cartoon questionnaire<br>* participants were asked to complete a questionnaire audio and animated cartoon on a platform<br>|
| No Intervention: text questionnaire group<br>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. | |
| Other: Parent group<br>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. | Other: audio and animated cartoon questionnaire<br>* participants were asked to complete a questionnaire audio and animated cartoon on a platform<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biospecific nonspecimen specimen, child and adolescent, cartoon, questionnaire, concent