An interventional study of Visual distractor in Unintentional Ingestion of Prescriptions Within Vials and Blisters, sponsored by Michigan State University. Completed at 3 sites in United States. Open to participants aged 2 Years to 54 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Michigan State University · Not applicable, Interventional, and Basic science
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:
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:
Outcome Measures Binary (package opened yes/no) Continuous variable (time to open for those successful)
36 studies on the registry are indexed under Blister; 3 are open to participants now.
This study's enrollment of 229 is above the median of 65 across 24 interventional studies indexed under Blister.
Browse Blister studies →Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Visual distractor
Package selection
Selection of one of three treatments in stage one testing (categorical variable)
Time frame: Day of experiment- Stage I
Time to opening
Time it takes a participant to successfully open a given treatment (continuous variable)
Time frame: Day of experiment (Stage II)
Time to selection (continuous variable)
Time it takes participants to select package (continuous variable)
Time frame: Day of the experiment- Stage I
Success/Failure to open
Success or failure in opening by package treatment (binary response variable)
Time frame: Day of the experiment (Stage II)
The record gives a start of Aug 2013, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.