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

NCT05874427 | Completed

• 1 other identifier: B-2206-761-303
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lumbar radiculopathy; Multimedia informed consent

Outcome Measures

Primary Outcomes (1)

• Patient comprehension assessed by Patient comprehension questionnaire

  A questionnaire to assess the understanding of the procedure in patients undergoing transforaminal epidural steroid injections, created by three pain medicine specialists. The test consists of 10 questions, all of which are answered with a yes/no response to provide a score from 0 to 10.

  immediately before the procedure

Secondary Outcomes (2)

• Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form

  immediately before the procedure

• Assess patient satisfaction by Patient satisfaction ratings on a Likert scale

  immediately after the procedure

Study Arms (2)

Multimedia informed consent

EXPERIMENTAL

Multimedia informed consent with videos to explain transforaminal epidural steroid injection

Procedure: Multimedia informed consent

Standard informed consent

ACTIVE COMPARATOR

A standard consent form to describe the procedure previously used.

Procedure: Standard informed consent

Interventions

Multimedia informed consent PROCEDURE

A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.

Multimedia informed consent

Standard informed consent PROCEDURE

A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.

Standard informed consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul national university Bundang hospital

Seongnam, Kyoungki-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 24, 2023
• Study Start: May 22, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

KR (1)