Visual Distraction as a Means of Enhancing Child Resistance
Condition: Unintentional Ingestion of Drugs Contained Within Prescription Vials and Blisters.
MeSH terms: Blister
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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)
    

Intervention name(s): Visual distractor
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Poison control; Child resistant packaging; prescription vials; prescription blisters; drug packaging