Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact Sheets

Parents Clinical Trial

Official title:

Parents Reading Comprehension of Their Child's Post-Operative Medicine Fact

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639470
• Other study ID #: IRBPHS#5229
• Status: Completed
• Phase: N/A
• First received: March 12, 2008
• Last updated: August 12, 2008
• Start date: August 2005
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to test legal guardians reading comprehension of their child's post-operative medication administration using three different versions of written medication information (standard fact sheets, easy-to-read fact sheets, and easy-to-read fact sheets accompanied by illustrations).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: August 2008
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Parents

Intervention

Other:
• easy to read fact sheets
easy to read fact sheets with illustrations and without illustrations

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension of the fact sheets as measured by the Cloze Readability Procedure.		On the day of discharge	No