Visual Distraction as a Means of Enhancing Child Resistance (VDCR)

Michigan State University

Status: Completed

Conditions: Unintentional Ingestion of Prescriptions Within Vials and Blisters

Treatments: Other: Visual distractor

Study type: Interventional

Funder types: Other

Identifiers

NCT01859780

13-246

Details and patient eligibility

About

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.

Full 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)

Enrollment: 229 patients

Sex: All

Ages: 2 years to 54 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Lactose allergy or lactose sensitivity

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

229 participants in 1 patient group

Prescription packages (vials and blisters)

Experimental group

Description:

Stage I Prescription vials and wallets (packaging) with three levels of distractor placement (hidden, absent and obvious) will be tested for an effect of placement on selection behavior and time to package selection. Stage II Prescription vials and wallets (packaging) with and without distractors will be tested for an effect on time to open and number of successful openings.

Treatment:

Other: Visual distractor