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NCT Number: NCT05874427

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

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.

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Key information

Conditions

Lumbar Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university Bundang hospital

Seongnam, Kyoungki-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimedia informed consent

Procedure

A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.

Standard informed consent

Procedure

A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 24, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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