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

Lumbar Radiculopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05874427
• Other study ID #: B-2206-761-303
• Status: Completed
• Phase: N/A
• Start date: May 22, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

Procedure:
• Multimedia informed consent
A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.
• Standard informed consent
A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university Bundang hospital	Seongnam	Kyoungki-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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