- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00639470
Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact Sheets
Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact
Study Overview
Detailed Description
It is important for the child's welfare and comfort that the legal guardian can read and comprehend their child's pain medication information. Failure to understand the full implications of the medication may jeopardize the child's comfort level or welfare. Readability of printed education materials is a key to comprehension and supplements what healthcare providers verbally tell the parents/legal guardians. Several studies have demonstrated the benefits of using illustrations to convey intended messages. Simple line drawings appear to do well with those who have low-literacy skills.
The following hypothesis will be tested:
- There is no difference in level of comprehension of medication administration by the legal guardians who receive standard fact sheets about medication, those who receive easy-to-read fact sheets, and those who receive easy-to-read fact sheets accompanied by illustrations.
- There is no difference in level of comprehension of pain assessment by the legal guardians who receive standard fact sheets about assessing pain, those who receive easy-to-read fact sheets, and those who receive easy-to-read facts sheets accompanied by illustrations.
- There is no relationship between legal guardians' satisfaction with medication education and whether they receive standard fact sheets, easy-to-read fact sheets, or those who receive easy-to read fact sheets accompanied by illustrations.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Syracuse, New York, United States, 13069
- SUNY Upstate Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- be 18 years of age or older or an emancipated minor
- ability to see, speak, and hear English
- have a child who will be undergoing surgery
- signed surgical consent form
- have a child staying on hospital pediatric surgical unit after surgery until discharge
- have a child admitted for at least one day but not more than 7 days.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Comprehension of the fact sheets as measured by the Cloze Readability Procedure.
Time Frame: On the day of discharge
|
On the day of discharge
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sharon Kitchie, PhD, State University of New York - Upstate Medical University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRBPHS#5229
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