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

Not Applicable

Completed

• Conditions: Lumbar Radiculopathy
• Interventions: Procedure: Multimedia informed consent; Procedure: Standard informed consent

• Registration Number: NCT05874427
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-10
• Study Start: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-24
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multimedia informed consent	Multimedia informed consent	Multimedia informed consent with videos to explain transforaminal epidural steroid injection
Standard informed consent	Standard informed consent	A standard consent form to describe the procedure previously used.

Primary Outcome Measures

Name	Time	Method
Patient comprehension assessed by Patient comprehension questionnaire	immediately before the procedure	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form	immediately before the procedure	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.
Assess patient satisfaction by Patient satisfaction ratings on a Likert scale	immediately after the procedure	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.

Trial Locations

Locations (1)

Seoul national university Bundang hospital; 🇰🇷 Seongnam, Kyoungki-do, Korea, Republic of