Visual Distraction as a Means of Enhancing Child Resistance



Status:Recruiting
Healthy:No
Age Range:2 - Any
Updated:3/16/2015
Start Date:August 2013

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Unintentional poisonings of children continues to be a major issue in the US. According to a
study conducted by Cincinnati Children's Hospital Medical Centers, during the period from
2001-2008, emergency room visits for children less than 5 rose 28% as the result of
pharmaceutical products. The authors note, "the problem of pediatric medication poisoning is
getting worse, not better."

Child resistant closures have been required on most medications sold in the US since the
early 1970s. However, most designs attempt to thwart children through purely physical means
(e.g. simultaneous dissimilar motion or opening using sequential tasks). Few, if any
designs, have utilized perception and cognition as a way to enhance child resistance.

The investigators propose utilizing visual illusions in spaces distinct from the opening
mechanism of prescription packages as a means of enhancing child resistance. In this
project, visual illusion images are applied to both vials and wallet blisters in order to
attract children's interest and prolong the time before opening.

During Stage I, the investigators will determine if the visual distractor attracts attention
when samples are displayed in a storage rack. During Stage II, the investigators will test
the effect of visual distractors on child resistance as measured by successful openings and
time to open.

Stage I

Objective: to determine if the visual distractor attracts attention when samples are
displayed in a storage rack.

Eligibility Criteria

To participate in this study children must:

- Be 2 years to 4 ½ years old

- Have parent's permission to be videotaped

- Have parent's signed permission (in the form of the official (IRB approved, signed
consent)

- Have no known history of lactose allergy or lactose sensitivity (packages contain a
lactose placebo)

- Verbally agree to participate after a brief explanation of what we want them to do

Outcome Measures Categorical variable (package choice) Continuous variable (time to choice)

Stage II Objective: to test the effect of visual distractors on child resistance as measured
by successful openings and time to open.

Eligibility Criteria

To participate in this stage of the study children must:

- Have no known history of lactose allergy or lactose sensitivity (packages contain a
lactose placebo)

- Be 2 years to 4 ½ years old

- Have their parent's permission to be videotaped

- Have their parent's permission (in the form of the official, IRB approved signed
consent)

- Verbally agree to participate after a brief explanation of what we want them to do

Outcome Measures Binary (package opened yes/no) Continuous variable (time to open for those
successful)

Inclusion Criteria:

- 2-4.5 years of age

- Parental permission to video tape

Exclusion Criteria:

- Lactose allergy or lactose sensitivity
We found this trial at
3
sites
Howell, Michigan 48843
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Howell, MI
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East Lansing, Michigan 48824
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East Lansing, MI
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Toledo, Ohio 43606
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Toledo, OH
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