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

Seoul National University Hospital34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lumbar Radiculopathy

Interventions

Multimedia informed consentPROCEDURE

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

Standard informed consentPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul national university Bundang hospital

Seongnam, Kyoungki-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: immediately before the procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: immediately after the procedure

Data from ClinicalTrials.gov

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