Informed Consent Using a Spinal Model

NCT06417866 | Completed

• 1 other identifier: 2023/719
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Pain

Keywords

pain; anxiety

Outcome Measures

Primary Outcomes (3)

• Informed consent form comprehension assessment

  The degree of understanding of the informed consent form evaluation with a 3-point Likert scale.

  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.

  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.

  1 day

Study Arms (2)

standard informed consent

standard verbal and written informed consent form

Other: informed consent

visual spinal model

standard verbal and written informed consent form + visual spinal model

Other: spine model

Interventions

informed consent OTHER

standard verbal and written informed consent

standard informed consent

spine model OTHER

standard verbal and written informed consent + visual spine model

visual spinal model

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 28760058 BACKGROUND

• Bahar 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.

  PMID: 34254651 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Pain

Interventions

Informed Consent

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Rights; Human Rights; Social Control, Formal; Health Care Economics and Organizations; Jurisprudence

Study Officials

• Hanzade A Unal, MD

  Ankara University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: January 2, 2024
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)