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Patient Understanding of Informed Consent in Interventional Pain Procedures

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07772843
Lead Sponsor Sanliurfa Education and Research Hospital
Collaborators: T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi, Sanliurfa Mehmet Akif Inan Education and Research Hospital
Conditions
(from sponsor)
Patient Understanding of Informed Consent Before Interventional Pain Procedures
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov