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NCT Number: NCT01859780

Visual Distraction as a Means of Enhancing Child Resistance

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.

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Key information

Conditions

Unintentional Ingestion of Prescriptions Within Vials and Blisters Blister Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vesiculobullous Skin and Connective Tissue Diseases

Age range

2 year–54 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Packaging Building, East Lansing, Michigan, United States

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 2-4.5 years of age
  • Parental permission to video tape

Exclusion criteria

  • Lactose allergy or lactose sensitivity

Treatment and study plan

Visual distractor

Other

Primary outcomes

  1. Package selection

    Time frame: Day of experiment- Stage I

    Selection of one of three treatments in stage one testing (categorical variable)

  2. Time to opening

    Time frame: Day of experiment (Stage II)

    Time it takes a participant to successfully open a given treatment (continuous variable)

Secondary outcomes

  1. Time to selection (continuous variable)

    Time frame: Day of the experiment- Stage I

    Time it takes participants to select package (continuous variable)

  2. Success/Failure to open

    Time frame: Day of the experiment (Stage II)

    Success or failure in opening by package treatment (binary response variable)

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Registry information

Acronym: VDCR

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 22, 2013
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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