- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02027597
Improving Oral Health With Serious Games (AOTSM)
This study investigated if computer games can be effective at changing the way children take care of their teeth. We a museum exhibit with 3D virtual reality games called "Attack of the S. Mutans!" Our hypothesis was that children who played the games and visited the exhibit would show improved attitudes about oral health, which would translate into improved brushing and self-care habits.
In this randomized controlled study with school children aged 8-12, we compared the outcomes for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on classroom presentation about virtual reality being used for healthcare; Group 3) Received no-treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98112
- Firsthand Technology Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
For participation in the study, enrollment criteria are as follows: 1) a dentist's diagnosis of tooth decay, or restorative dental work in the previous year; and 2) Parents or guardians provide usable baseline data, including contact information for follow-up questionnaires.
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Video Game Treatment
This group received the AOTSM game experience followed by additional oral health information.
They did not receive any follow-up treatment after the exhibit.
|
A research assistant led groups of students through the Attack of the S. Mutans exhibit.
All participants played all the games and viewed all the graphical content of the exhibit.
Other Names:
|
|
Active Comparator: Control
Instead of playing Attack of the S. Mutans!, children in the control group attended a 90 minute classroom session about virtual reality applications for relieving pain and for therapy.
This content was unrelated to oral health.
|
SnowWorld is a 3D first-person-shooter game developed by Firsthand Technology.
In SnowWorld, the player shoots snowballs at penguins, polar bears, and other features of a frozen landscape.
The game is designed to help burn victims cope with pain, and has no oral health messages.
|
|
Experimental: Video Game Treatment Plus Follow-Up
Children assigned to the Treatment-Plus conditions not only had the Attack of the S. Mutans video game experience, but also gained access to an educational website that reinforced the exhibit's teachings two months later.
These students received a special login and password in the mail and were instructed to visit the site before completing their next questionnaire.
|
A research assistant led groups of students through the Attack of the S. Mutans exhibit.
All participants played all the games and viewed all the graphical content of the exhibit.
Other Names:
This group experienced the Attack of the S. Mutans! exhibit and 3 doses of follow-up booster content at a web site.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy
Time Frame: 8 months post treatment
|
Follow-up surveys were conducted at 3 points after the intervention for all groups.
The survey included questions about the children's attitudes (self-efficacy) toward oral health and taking care of their teeth.
Surveys were paper-pencil self-reports from both parents and children.
Items were drawn from Morowatisharifabad and Shirazi, (2007) and adapted for ease of understanding for English speaking children.
|
8 months post treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-care behavior
Time Frame: 8 months post treatment
|
Separate surveys of children and their parents were conducted at 3 points after the intervention all groups.
The survey included questions about how often and how well the children took care of their teeth.
|
8 months post treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oral health literacy
Time Frame: 8 months post treatment
|
we assessed children's oral health knowledge in two ways.
First, children reported their overall oral health knowledge using three-point rating scales (=not really to 3=mostly) to respond to six items, including, "By brushing and flossing my teeth, I am less susceptible to tooth decay."
Negatively worded items were reverse-coded, and the estimated internal consistency (Cronbach's alpha) of the pre-game survey was.49.
Second, children indicated their brushing knowledge using five-point rating scales (1=strongly disagree to 5=strongly agree) to respond to four items, including "Tooth brushing gets rid of bad breath."
|
8 months post treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Howard A Rose, M.Ed., Firsthand Technology
- Principal Investigator: Ari J Hollander, MSE, Firsthand Technology
Publications and helpful links
Helpful Links
- Project web site describing the study. Can view video and content from Attack of the S. Mutans!
- Web site for Firsthand Technology, creators of Attack of the S. Mutans!
- Mobile app to conduct caries risk assessments and educate patients about the causes of caries. Created by Firsthand Technology and UCSF School of Dentistry. Incorporates graphics and video from Attack of the S. Mutans!
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35095-EB
- 5R44DE019043-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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