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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimedia informed consent | Experimental | Multimedia informed consent with videos to explain transforaminal epidural steroid injection |
|
| Standard informed consent | Active Comparator | A standard consent form to describe the procedure previously used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimedia informed consent | Procedure | A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul national university Bundang hospital | Seongnam | Kyoungki-do | 463-707 | South Korea |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| 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. |
|
| 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 |