NCT04179240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

December 2, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

November 25, 2019

Last Update Submit

November 27, 2019

Conditions

Child DevelopmentEthics, Narrative

Keywords

biospecific nonspecimen specimenchild and adolescentcartoonquestionnaireconcent

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

audio and animated cartoon questionnaire group

EXPERIMENTAL

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

text questionnaire group

NO INTERVENTION

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.

Parent group

OTHER

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

Interventions

audio and animated cartoon questionnaireOTHER

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

Parent groupaudio and animated cartoon questionnaire group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients with obvious communication difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Narration

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Shijian Liu

    Shanghai Children's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shijian Liu

CONTACT

86-21-38625637liushijian@scmc.com.cn

Shanshan Qiu

CONTACT

86-21-38626161qiushanshan1101@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 25, 2019

First Posted

November 27, 2019

Study Start

November 26, 2019

Primary Completion

August 31, 2020

Study Completion

October 30, 2020

Last Updated

December 2, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)