Informed Consent Using a Spinal Model

May 15, 2024 updated by: Hanzade Aybuke Unal, Ankara University

Enhancing Informed Consent Utilizing a Spinal Model for Lumbar Epidural Steroid Injection: A Prospective Randomized Controlled Study.

Informed consent is the first step in every medical procedure. It is important for the patient to clearly understand how the procedure will be performed, what to expect from the process, and the possible complications. Any of the specified processes disruption may alter procedure satisfaction and treatment outcomes. Studies have reported that providing insufficient information before interventional procedures increases anxiety and the severity of pain during the procedure. In this study, alongside the standard procedures for obtaining oral and written consent, it is envisaged to augment patient comprehension and engagement by visually demonstrating the treatment areas and needle insertion points using a spinal model. Within the study framework, patients will be presented with both verbal and written informed consent, supplemented by visual aids utilizing a spinal model. The study aims to assess and compare the efficacy of this enhanced consent process in terms of patient understanding, procedural acceptance, and subsequent satisfaction levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The informed consent process includes the processes of explanation, understanding, selection and approval of the volunteer. For informed consent to be valid, the patient must obtain sufficient information about the procedure, be in communication with the physician, be voluntary, and have the capacity to give consent. In our country, informed consent forms usually include a physician-patient interview, reading and signing of the written text. Although informed consent forms are written in a language that patients can understand, they can be complicated for patients. Studies have shown that video and other audio-visual materials significantly improve patients' understanding of the subject. It has been proven to facilitate follow-up and increase compliance with the treatment plan. Informed consent using multimedia tools is reported to be effective.

Lumbar radiculopathy is a condition characterized by pain that can affect daily life and is one of the most common causes of low back pain. Epidural steroid injections can be applied to patients that do not benefit from conservative treatment. Lumbar epidural steroid injections are a minimally invasive procedure and their method of application in society is not clearly known. This procedure is performed with a needle and accompanied by imaging techniques, without any incision. There are a limited number of studies on informed consent forms before lumbar epidural applications. In a study, it was found that patients who did not understand the consent form or received insufficient information had lower post-procedure satisfaction. In another study it stated that in patients who were given a brochure explaining the procedure in addition to verbal and written consent, giving the brochure had no effect on pre-procedure anxiety and post-procedure pain severity.

Verbal and written consent is routinely obtained from patients who are planned to receive lumbar epidural steroid injection in our clinic. In this study, in addition to the routine oral and written consent, it is planned to show the patients the areas to be treated and where the needle will be placed via a spinal model. Within the scope of the study, patients were provided with verbal and written informed consent and visual illustrations through a spine model in addition to verbal and written informed consent. The aim of the study is to compare the level of understanding of consent, acceptance of the procedure and its effect on patient satisfaction after the procedure.

Study Type

Observational

Enrollment (Actual)

168

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

  • Turkey
      • Ankara, Turkey, 06230
        • Ankara University

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

No

Sampling Method

Non-Probability Sample

Study Population

Patients between the ages of 18 and 65 who are scheduled to receive lumbar epidural steroid injection due to radicular pain will be included in the study.

Description

Inclusion Criteria:

  • Patients scheduled for lumbar epidural steroid injection due to radicular pain
  • Patients who gave consent to participate in the study

Exclusion Criteria:

  • Presence of psychiatric illness that is unstable/not controlled by medical treatment
  • Pregnant patients
  • Patients who have previously received epidural steroid injections
  • Patients who did not give consent to participate in the study
  • Patients with cognitive impairment
  • Patients with major coagulopathy
  • Patients with mental disabilities
  • Illiterate patients

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
standard informed consent
standard verbal and written informed consent form
Other: informed consent
standard verbal and written informed consent
visual spinal model
standard verbal and written informed consent form + visual spinal model
Other: spine model
standard verbal and written informed consent + visual spine model

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Informed consent form comprehension assessment
Time Frame: 1 day
The degree of understanding of the informed consent form evaluation with a 3-point Likert scale.
1 day
Patient satisfaction after the procedure
Time Frame: 1st hour
The degree of patient satisfaction evaluation after the lumbar epidural steroid injection with a 5-point Likert scale.
1st hour
anxiety and depression
Time Frame: 1 day
anxiety and depression evaluation before the procedure with Hospital Anxiety and Depression Scale (HADS). A score of 0-7 in the survey indicates normal, 8-10 points indicates borderline, and 11 and above indicates anxiety/depression.The maximum score that can be obtained from the survey is 42, and higher scores are associated with worse outcome.
1 day

Collaborators and Investigators

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

Sponsor

Ankara University

Investigators

  • Study Director: Hanzade A Unal, MD, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 2, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 15, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/719

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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