NCT05874427

Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form

Comparison of Patient Understanding and Anxiety Between the New Imaging Consent Form and the Existing Narrative Consent Form When Explaining the Procedure Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, double-blind clinical study to compare patient comprehension and anxiety by comparing a traditional paper consent form to a multimedia consent form for patients undergoing transforaminal epidural steroid injection.

Conditions

• Lumbar Radiculopathy

Interventions

Type	Name	Description
PROCEDURE	Multimedia informed consent	A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.
PROCEDURE	Standard informed consent	A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.

Timeline

• Start date: 2023-05-22
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2023-05-24
• Last updated: 2024-04-04

Locations

1 site across 1 country: South Korea