Patient Understanding of Informed Consent in Interventional Pain Procedures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorSanliurfa Education and Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Simplified and Visually Supported Procedure-Specific Information Card
BehavioralAn 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
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Patient Understanding of Informed Consent Assessed by Teach-Back
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.
Time frame
Immediately after the informed consent process and before the planned clinical procedureSponsors and contacts
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Sanliurfa Education and Research Hospital
Lead sponsor
T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi
Collaborator
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Collaborator
Source ClinicalTrials.gov
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