NCT05874427CompletedNot Applicable
Comparison of Patient Understanding and Anxiety Between the New Imaging Consent Form and the Existing Narrative Consent Form When Explaining the Procedure Pilot Study
Seoul National University Hospital2 sites in 2 countries34 target enrollmentStarted: May 22, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Patient comprehension assessed by Patient comprehension questionnaire
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Patient comprehension assessed by Patient comprehension questionnaire
Time Frame: 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 Outcomes
- Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form(immediately before the procedure)
- Assess patient satisfaction by Patient satisfaction ratings on a Likert scale(immediately after the procedure)
Investigators
Pyung-Bok Lee
Principal Investigator
Seoul National University Hospital
Study Sites (2)
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