Back to resultsComparison Between the Imaging Consent Form and the Existing Narrative Consent Form
Primary Purpose
Lumbar Radiculopathy
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Multimedia informed consent
Standard informed consent
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Radiculopathy focused on measuring lumbar radiculopathy, Multimedia informed consent
Eligibility Criteria
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
Sites / Locations
- Seoul national university Bundang hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multimedia informed consent
Standard informed consent
Arm Description
Multimedia informed consent with videos to explain transforaminal epidural steroid injection
A standard consent form to describe the procedure previously used.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05874427
First Posted
May 10, 2023
Last Updated
June 26, 2023
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05874427
Brief Title
Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form
Official Title
Comparison of Patient Understanding and Anxiety Between the New Imaging Consent Form and the Existing Narrative Consent Form When Explaining the Procedure Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2023 (Actual)
Primary Completion Date
July 22, 2023 (Anticipated)
Study Completion Date
July 22, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy
Keywords
lumbar radiculopathy, Multimedia informed consent
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multimedia informed consent
Arm Type
Experimental
Arm Description
Multimedia informed consent with videos to explain transforaminal epidural steroid injection
Arm Title
Standard informed consent
Arm Type
Active Comparator
Arm Description
A standard consent form to describe the procedure previously used.
Intervention Type
Procedure
Intervention Name(s)
Multimedia informed consent
Intervention Description
A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.
Intervention Type
Procedure
Intervention Name(s)
Standard informed consent
Intervention Description
A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.
Primary Outcome Measure Information:
Title
Patient comprehension assessed by Patient comprehension questionnaire
Description
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 Outcome Measure Information:
Title
Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form
Description
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
Title
Assess patient satisfaction by Patient satisfaction ratings on a Likert scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pyung Bok Lee, MD, Ph. D.
Phone
+82-031-787-7495
Email
painfree@snubh.org
Facility Information:
Facility Name
Seoul national university Bundang hospital
City
Seongnam
State/Province
Kyoungki-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pyung Bok Lee, MD, PhD
Phone
82-31-787-7495
Email
painfree@snubh.org
12. IPD Sharing Statement
Learn more about this trial
Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form
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