An interventional study of Simplified and Visually Supported Procedure-Specific Information Card in Patient Understanding of Informed Consent Before Interventional Pain Procedures, sponsored by Sanliurfa Education and Research Hospital. Not yet recruiting at 3 sites in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Sanliurfa Education and Research Hospital · Not applicable, Interventional, and Other
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 360 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Sanliurfa Education and Research Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the control group will receive the standard verbal explanation and the institution-approved written informed consent form for the planned interventional pain procedure. No additional educational material will be provided.
Participants in the intervention group will receive the standard verbal explanation and the institution-approved written informed consent form for the planned interventional pain procedure, plus an ethics committee-approved simplified and visually supported procedure-specific information card.
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
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 procedure
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 2 months is below that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Sanliurfa Education and Research Hospital