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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Patient Understanding and Anxiety Between the New Imaging Consent Form and the Existing Narrative Consent Form When Explaining the Procedure Pilot Study

Conditions
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Lumbar Radiculopathy

Intervention / Treatment
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* Procedure: Multimedia informed consent
* Procedure: Standard informed consent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimedia informed consent<br>Multimedia informed consent with videos to explain transforaminal epidural steroid injection | Procedure: Multimedia informed consent<br>* A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.<br>|
| Active Comparator: Standard informed consent<br>A standard consent form to describe the procedure previously used. | Procedure: Standard informed consent<br>* A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lumbar radiculopathy, Multimedia informed consent