AnxietyNCT06417866
Informed Consent Using a Spinal Model
An observational study of Anxiety and Depression, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety, Depression, Pain
- What is being tested?
- informed consent and spine model
- How many people
- 168 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 1 May 2024
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients scheduled for lumbar epidural steroid injection due to radicular pain
- Patients who gave consent to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety, Depression, Pain
- Being tested
- informed consent, spine model
- Keywords
- pain, anxiety
- Medical subject headings
- Anxiety Disorders, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
informed consentOther
standard verbal and written informed consent
spine modelOther
standard verbal and written informed consent + visual spine model
| Study group | Role | What they receive |
|---|---|---|
| standard informed consent | standard verbal and written informed consent form Receives: Other: informed consent | |
| visual spinal model | standard verbal and written informed consent form + visual spinal model Receives: Other: spine model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Informed consent form comprehension assessment
The degree of understanding of the informed consent form evaluation with a 3-point Likert scale.
Measured: 1 day
Patient satisfaction after the procedure
The degree of patient satisfaction evaluation after the lumbar epidural steroid injection with a 5-point Likert scale.
Measured: 1st hour
anxiety and depression
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 Jan 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanzade Aybuke Unal, Ankara University
- Investigators
- Hanzade A Unal, MD, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417866
- Sponsor's protocol ID
- 2023/719
- Status last verified
- May 2024
- First submitted
- 10 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ketelaars PJW, Buskes MHM, Bosgraaf RP, van Hamont D, Prins JB, Massuger LFAG, Melchers WJG, Bekkers RLM. The effect of video information on anxiety levels in women attending colposcopy: a randomized controlled trial. Acta Oncol. 2017 Dec;56(12):1728-1733. doi: 10.1080/0284186X.2017.1355108. Epub 2017 Aug 1.
PubMed 28760058Bahar Ozdemir Y, Sencan S, Ercalik T, Kokar S, Gunduz OH. Do informative leaflets affect pre-procedural anxiety and immediate pain after transforaminal epidural steroid injections? A prospective randomized controlled study. Agri. 2021 Jan;33(1):1-6. doi: 10.14744/agri.2020.27048.
PubMed 34254651
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Informed Consent Utilizing a Spinal Model for Lumbar Epidural Steroid Injection: A Prospective Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT06417866
- Acronym / sponsor ID
- 2023/719
- Conditions
- Anxiety, Depression, Pain
- Keywords
- pain, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 16 May 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard informed consent | – | Other: informed consentstandard verbal and written informed consent form |
| visual spinal model | – | Other: spine modelstandard verbal and written informed consent form + visual spinal model |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients scheduled for lumbar epidural steroid injection due to radicular pain
- Patients who gave consent to participate in the study
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| informed consentstandard verbal and written informed consent | Other | standard informed consent |
| spine modelstandard verbal and written informed consent + visual spine model | Other | visual spinal model |
Primary outcome
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.
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.
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.
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 16 May 2024.
- Background: PubMed 28760058Ketelaars PJW, Buskes MHM, Bosgraaf RP, van Hamont D, Prins JB, Massuger LFAG, Melchers WJG, Bekkers RLM. The effect of video information on anxiety levels in women attending colposcopy: a randomized controlled trial. Acta Oncol. 2017 Dec;56(12):1728-1733. doi: 10.1080/0284186X.2017.1355108. Epub 2017 Aug 1.
- Background: PubMed 34254651Bahar Ozdemir Y, Sencan S, Ercalik T, Kokar S, Gunduz OH. Do informative leaflets affect pre-procedural anxiety and immediate pain after transforaminal epidural steroid injections? A prospective randomized controlled study. Agri. 2021 Jan;33(1):1-6. doi: 10.14744/agri.2020.27048.
- Individual participant dataSharing planned: No
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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.
Hanzade A Unal, MD study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Depression, run by Ankara University at 1 site in Turkey (Türkiye).
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 2 inclusion and 8 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 16 May 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 Turkey (Türkiye). 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?
Informed consent form comprehension assessment (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06417866, which also lists 2 linked publications.
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 16 May 2024.