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

April 3, 2024 updated by: Pyung-Bok Lee, Seoul National University Hospital

Comparison of Patient Understanding and Anxiety Between the New Imaging Consent Form and the Existing Narrative Consent Form When Explaining the Procedure Pilot Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Kyoungki-do
      • Seongnam, Kyoungki-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimedia informed consent
Multimedia informed consent with videos to explain transforaminal epidural steroid injection
Procedure: Multimedia informed consent
A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.
Active Comparator: Standard informed consent
A standard consent form to describe the procedure previously used.
Procedure: Standard informed consent
A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
immediately before the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form
Time Frame: 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.
immediately before the procedure
Assess patient satisfaction by Patient satisfaction ratings on a Likert scale
Time Frame: 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.
immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

May 10, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2206-761-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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