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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02027597
Other study ID # 35095-EB
Secondary ID 5R44DE019043-02
Status Completed
Phase N/A
First received January 2, 2014
Last updated January 3, 2014
Start date October 2008
Est. completion date August 2011

Study information

Verified date January 2014
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date August 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 8 Years to 12 Years
Eligibility 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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Attack of the S. Mutans
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.
Follow-up
This group experienced the Attack of the S. Mutans! exhibit and 3 doses of follow-up booster content at a web site.
SnowWorld
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.

Locations

Country Name City State
United States Firsthand Technology Inc. Seattle Washington

Sponsors (3)

Lead Sponsor Collaborator
University of Washington National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Oral health literacy 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 No
Primary Self-Efficacy 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 No
Secondary Self-care behavior 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 Yes
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