Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417866
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
Informed Consent Using a Spinal Model
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
Enhancing Informed Consent Utilizing a Spinal Model for Lumbar Epidural Steroid Injection A Prospective Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None