Lumbar Radiculopathy
Conditions
Keywords
lumbar radiculopathy, Multimedia informed consent
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.
Interventions
PROCEDUREMultimedia informed consent
A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.
PROCEDUREStandard informed consent
A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed