Patient Understanding of Informed Consent in Interventional Pain Procedures
Evaluation of Patient Understanding of Informed Consent Before Interventional Pain Procedures: A Multicenter Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yağmur Can Dadakçı
- Phone Number: +905333599730
- Email: yagmurcand@gmail.com
Study Locations
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Ankara
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Ankara, Ankara, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
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Contact:
- erkan yavuz akcaboy, prof. dr.
- Phone Number: +905054514664
- Email: akcaboyyavuz@gmail.com
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Şanlıurfa
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Sanliurfa, Şanlıurfa, Turkey (Türkiye), 63200
- Sanliurfa Education and Research Hospital
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Contact:
- Yağmur Can Dadakçı
- Phone Number: +905333599730
- Email: yagmurcand@gmail.com
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Sanliurfa, Şanlıurfa, Turkey (Türkiye), 63300
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
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Contact:
- ahmet cemal kaya
- Phone Number: +905393458515
- Email: ahmetcemal.kaya@saglik.gov.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
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.
|
|
|
Experimental: Intervention Group
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Understanding of Informed Consent Assessed by Teach-Back
Time Frame: 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.
|
Immediately after the informed consent process and before the planned clinical procedure
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yağmur Can Dadakçı, Sanliurfa Education and Research Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HÜ-KAEK-2026-00079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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