Use of Portable Technology in Patient Education of Shave/Punch Biopsies

Biopsy Clinical Trial

Official title:

Use of MP3 Portable Technology in Patient Education and Informed Consent of Shave and Punch Biopsies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110148
• Other study ID #: 200917169-1
• Status: Completed
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 23, 2010
• Start date: July 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators investigated the use of portable MP3 technology in patient education and informed consent of shave and punch biopsies. Eighty patients were divided randomly into a control and experimental group. Control patients received the standard of care in patient education and informed consent. Experimental patients watched a short 80-second video on shave or punch biopsies. All patients were given pre- and post-education questionnaires to assess the efficacy of each method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaker

• Receiving shave or punch biopsy

Exclusion Criteria:

• Under 18 years of age

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Biopsy

Intervention

Other:
• video-based informed consent for skin biopsies
video-based informed consent for punch and shave biopsies
• traditional informed consent
traditional informed consent (standard of care) from physicians for shave and punch biopsies

Locations

Country	Name	City	State
United States	University of California Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the post-education knowledge of each intervention arm	Compare the post-education knowledge between the two intervention arms: one conventional informed consent process, the other video-based informed consent process. Knowledge will be measured through a questionnaire administered before and after patient education is given.	at the end of the study visit	No