Patient Understanding of Informed Consent in Interventional Pain Procedures

Overview

This multicenter randomized controlled study will evaluate whether simplified and visually supported procedure-specific information cards improve patients' understanding of informed consent before selected interventional pain procedures. Adult patients scheduled for an eligible procedure will be randomly assigned in a 1:1 ratio to either a control group or an intervention group. All participants will receive the routine verbal explanation and the standard institution-approved informed consent form for the planned procedure. Participants in the intervention group will additionally receive an ethics committee-approved simplified and visually supported information card related to the planned procedure. Participants in the control group will not receive the additional information card. After the information and consent process, patient understanding will be assessed using a standardized teach-back form before the clinical procedure. The study will compare understanding between the two groups.

Informed consent is an essential component of patient autonomy and ethical clinical care. However, patients may not fully understand the purpose, potential risks, and alternatives of an interventional procedure, even when routine verbal explanations and written consent forms are provided. Complex medical terminology, limited time, and differences in health literacy may affect patient comprehension. This prospective, multicenter, randomized, parallel-group study will investigate whether adding simplified and visually supported procedure-specific information cards to the standard informed consent process improves patient understanding before selected interventional pain procedures. The study will include adult patients between 18 and 85 years of age who are scheduled to undergo one of the interventional pain procedures included in the approved protocol. Eligible procedures include piriformis injection, occipital nerve block, transforaminal epidural steroid injection, radiofrequency procedures, and intra-articular shoulder injection. Participants must be able to read, understand, and communicate in Turkish and must provide written informed consent for participation in the study. Patients with serious cognitive impairment or mental incapacity affecting the consent process, severe hearing or visual loss, an active psychiatric episode affecting perception or expression, or a condition requiring urgent intervention will be excluded. Patients who do not agree to participate will also be excluded. After eligibility assessment and written consent for study participation, all participants will receive the routine clinical explanation and the standard institution-approved informed consent form for the planned procedure. Participants will then be randomly assigned in a 1:1 ratio to the control group or the intervention group. Participants in the control group will receive the standard informed consent process alone. Participants in the intervention group will receive the same standard informed consent process plus an ethics committee-approved simplified and visually supported information card specific to the planned procedure. The information card is an additional educational material and does not replace the physician's clinical explanation or the legally required informed consent form. After completion of the information and consent process and before the planned clinical procedure, patient understanding will be assessed in both groups using a standardized teach-back assessment form. During the teach-back assessment, participants will be asked to explain the relevant information in their own words. The assessment will focus on understanding of the planned procedure and the key information provided during the consent process. The primary analysis will compare the teach-back understanding scores between the control and intervention groups. The planned target enrollment is 360 participants across the participating centers. The study is planned to be conducted at the following centers: Sanliurfa Education and Research Hospital, Sanliurfa Mehmet Akif Inan Education and Research Hospital, and Ankara Bilkent City Hospital. The study has received approval from the Harran University Clinical Research Ethics Committee under approval number HÜ-KAEK-2026-00079.