NCT02027597

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

January 2, 2014

Last Update Submit

January 3, 2014

Conditions

Keywords

video gamesoral healthsocial cognitive theorybehavior changerandomized trialgrowth modelingminoritygender

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Self-care behavior

    8 months post treatment

Other Outcomes (1)

  • Oral health literacy

    8 months post treatment

Study Arms (3)

Video Game Treatment

EXPERIMENTAL

This group received the AOTSM game experience followed by additional oral health information. They did not receive any follow-up treatment after the exhibit.

Other: Attack of the S. Mutans

Control

ACTIVE COMPARATOR

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.

Other: SnowWorld

Video Game Treatment Plus Follow-Up

EXPERIMENTAL

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.

Other: Attack of the S. MutansOther: Follow-up

Interventions

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.

Also known as: AOTSM
Video Game TreatmentVideo Game Treatment Plus Follow-Up

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

Video Game Treatment Plus Follow-Up

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.

Control

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firsthand Technology Inc.

Seattle, Washington, 98112, United States

Location

Related Links

MeSH Terms

Conditions

Dental CariesGingivitisCoitus

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesSexual BehaviorBehavior

Study Officials

  • Howard A Rose, M.Ed.

    Firsthand Technology

    PRINCIPAL INVESTIGATOR
  • Ari J Hollander, MSE

    Firsthand Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Acting Assistant Professor, Oral Health Sciences

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 6, 2014

Study Start

October 1, 2008

Primary Completion

December 1, 2010

Study Completion

August 1, 2011

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations