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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Radiculopathy
• Intervention / Treatment: Procedure: Multimedia informed consent; Procedure: Standard informed consent

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pyung Bok Lee, MD, Ph. D.; Phone Number: +82-031-787-7495; Email: painfree@snubh.org

Study Locations

• Korea, Republic of
  • Kyoungki-do
    • Seongnam, Kyoungki-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital
      • Contact: Pyung Bok Lee, MD, PhD; Phone Number: 82-31-787-7495; Email: painfree@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multimedia informed consent; Multimedia informed consent with videos to explain transforaminal epidural steroid injection	Procedure: Multimedia informed consent; A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.
Active Comparator: Standard informed consent; A standard consent form to describe the procedure previously used.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form	used to measure the state and trait components of anxiety The test consists of six questions, each of which is scored on a scale from not at all (1) to very much so (4), depending on the patient's response. Scores range from 6 to 24, with lower scores indicating higher anxiety state.	immediately before the procedure
Assess patient satisfaction by Patient satisfaction ratings on a Likert scale	Patient satisfaction ratings on a Likert scale The test consists of five questions, each of which is answered on a scale from not at all (0) to very much so (4), depending on the patient's response. Scores range from 0 to 20, with higher scores indicating better understanding.	immediately after the procedure

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lumbar radiculopathy; Multimedia informed consent
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: B-2206-761-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No