Lumbar RadiculopathyNCT05874427
Comparison Between the Imaging Consent Form and the Existing Narrative Consent Form
A study testing Multimedia informed consent and Standard informed consent in people with Lumbar Radiculopathy, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Multimedia informed consent and Standard informed consent
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who have difficulty understanding or answering consent forms
- Patients who have previously experienced a transforaminal steroid injection
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national university Bundang hospital
Seongnam, Kyoungki-do, 463-707
About this study
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
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.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Multimedia informed consent, Standard informed consent
- Keywords
- lumbar radiculopathy, Multimedia informed consent
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia informed consentProcedure or surgery
A standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks.
Standard informed consentProcedure or surgery
A standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician.
| Study group | Role | What they receive |
|---|---|---|
| Multimedia informed consent | Experimental | Multimedia informed consent with videos to explain transforaminal epidural steroid injection Receives: Procedure: Multimedia informed consent |
| Standard informed consent | Active comparator | A standard consent form to describe the procedure previously used. Receives: Procedure: Standard informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately before the procedure
Secondary outcomes (2)
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.
Measured: immediately before the procedure
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.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start22 May 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pyung-Bok Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874427
- Sponsor's protocol ID
- B-2206-761-303
- Status last verified
- Apr 2024
- First submitted
- 10 May 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05874427
- Acronym / sponsor ID
- B-2206-761-303
- Conditions
- Lumbar Radiculopathy
- Keywords
- lumbar radiculopathy, Multimedia informed consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimedia informed consent | Experimental | Procedure: Multimedia informed consentMultimedia informed consent with videos to explain transforaminal epidural steroid injection |
| Standard informed consent | Active comparator | Procedure: Standard informed consentA standard consent form to describe the procedure previously used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who have difficulty understanding or answering consent forms
- Patients who have previously experienced a transforaminal steroid injection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia informed consentA standard consent form on paper to explain the procedure, with an additional video to explain the procedure and risks. | Procedure or surgery | Multimedia informed consent |
| Standard informed consentA standard consent form, written on paper, used to explain a procedure to a patient face-to-face by a physician. | Procedure or surgery | Standard informed consent |
Primary outcome
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.
2 secondary outcomes
Anxiety assessed by Spielberger State-Trait Anxiety Inventory (STAI) short form
Time frame: immediately before the procedure
Assess patient satisfaction by Patient satisfaction ratings on a Likert scale
Time frame: immediately after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia informed consent and Standard informed consent in people with Lumbar Radiculopathy, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient comprehension assessed by Patient comprehension questionnaire (time frame: immediately before the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.