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Patient Understanding of Informed Consent in Interventional Pain Procedures

NCT07772843 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-08-19

No results posted yet for this study

Summary

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.

Conditions

  • Patient Understanding of Informed Consent Before Interventional Pain Procedures

Interventions

BEHAVIORAL

Simplified and Visually Supported Procedure-Specific Information Card

An ethics committee-approved simplified and visually supported information card specific to the planned interventional pain procedure. This card uses plain language and schematic illustrations to highlight key aspects such as procedure purpose, steps, and potential risks. It is provided to participants in the intervention group as an educational supplement in addition to the standard informed consent process

Sponsors & Collaborators

  • T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi

    collaborator OTHER

  • Sanliurfa Mehmet Akif Inan Education and Research Hospital

    collaborator OTHER

  • Sanliurfa Education and Research Hospital

    lead OTHER_GOV

Principal Investigators

  • Yağmur Can Dadakçı · Sanliurfa Education and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772843 on ClinicalTrials.gov