Using a Cartoon Questionnaire to Improve Consent of Children

NCT ID: NCT04179240

Last Updated: 2019-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-26

Study Completion Date

2020-10-30

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.

Conditions

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Child Development Ethics, Narrative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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audio and animated cartoon questionnaire group

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.

Group Type EXPERIMENTAL

audio and animated cartoon questionnaire

Intervention Type OTHER

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

text questionnaire group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Parent group

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.

Group Type OTHER

audio and animated cartoon questionnaire

Intervention Type OTHER

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

Interventions

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audio and animated cartoon questionnaire

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

Intervention Type OTHER

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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Sijia Gu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shijian Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Medical Center

Locations

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Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shijian Liu

Role: CONTACT

86-21-38625637

Shanshan Qiu

Role: CONTACT

86-21-38626161

Facility Contacts

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Shijian Liu, Ph.D

Role: primary

21-38625637

Other Identifiers

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SCMCIRB-K2016069

Identifier Type: -

Identifier Source: org_study_id

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