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Clinical Trials in Turkey / NCT07772843
Starting soon Not applicable

Patient Understanding of Informed Consent in Interventional Pain Procedures

NCT07772843 · tracked via the Priya Life Science Turkey tracker
Sponsor
Sanliurfa Education and Research Hospital
Phase
Not applicable
Started
2026-08-17
Last updated
2026-08-19

Condition(s) studied

Patient Understanding of Informed Consent Before Interventional Pain Procedures

Investigational drug(s) / intervention(s)

Simplified and Visually Supported Procedure-Specific Information Card

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Adults aged 18 to 85 years. * Patients scheduled to undergo an eligible interventional pain procedure included in the approved study protocol. * Ability to read, understand, and communicate in Turkish. * Ability to understand the study information and provide written informed consent for participation. * Willingness to participate in the study. Exclusion Criteria: * Age below 18 years or above 85 years. * Severe cognitive impairment, mental incapacity, or any condition that prevents reliable understanding of the consent information or completion of the teach-back assessment. * Severe hearing or visual impairment that prevents the participant from receiving or understanding the study information, unless adequately corrected. * Active psychiatric illness or acute psychiatric episode that may affect comprehension, communication, or voluntary consent. * Emergency clinical condition requiring immediate intervention. * Inability or unwillingness to complete the teach-back assessment. * Inability or unwillingness to provide written informed consent for participation.

Primary outcome measure(s)

  • Patient Understanding of Informed Consent Assessed by Teach-Back — Immediately after the informed consent process and before the planned clinical procedure
    Patient understanding of the information provided during the informed consent process, assessed using a standardized teach-back form. Participants will be asked to explain the key information about the planned interventional pain procedure in their own words. The primary analysis will compare teach-back understanding between the control group and the intervention group.

Trial sites (3)

FacilityCityRegionStatus
Ankara Bilkent City Hospital Ankara Ankara
Sanliurfa Education and Research Hospital Sanliurfa Şanlıurfa
Sanliurfa Mehmet Akif Inan Education and Research Hospital Sanliurfa Şanlıurfa

More Sanliurfa Education and Research Hospital trials in Turkey

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AI-Assisted Written Information in Symptomatic Hemorrhoidal Disease Recruiting
Fetal Cardiac Effects of Tocolytic Nifedipine and Magnesium Sulfate Active, not recruiting
Comparison of Diagnostic Methods in Patients Operated for Suspected Appendicitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07772843 on ClinicalTrials.gov ↗ ← All trials in Turkey