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

Seoul National University

Status: Completed

Conditions: Lumbar Radiculopathy

Treatments: Procedure: Standard informed consent; Procedure: Multimedia informed consent

Study type: Interventional

Funder types: Other

Identifiers

NCT05874427

B-2206-761-303

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Patients undergoing lumbar transforaminal block for the first time
• Patients who are able to understand the contents of the video consent form and written consent form.

Exclusion criteria

• Patients who have difficulty understanding or answering consent forms
• Patients who have previously experienced a transforaminal steroid injection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Multimedia informed consent

Experimental group

Description:

Multimedia informed consent with videos to explain transforaminal epidural steroid injection

Treatment:

Procedure: Multimedia informed consent

Standard informed consent

Active Comparator group

Description:

A standard consent form to describe the procedure previously used.

Treatment:

Procedure: Standard informed consent