Patient Understanding of Informed Consent Before Interventional Pain ProceduresNCT07772843
Patient Understanding of Informed Consent in Interventional Pain Procedures
A study testing Simplified and Visually Supported Procedure-Specific Information Card in people with Patient Understanding of Informed Consent Before Interventional Pain Procedures, run by Sanliurfa Education and Research Hospital at 3 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Patient Understanding of Informed Consent Before Interventional Pain Procedures
- What is being tested?
- Simplified and Visually Supported Procedure-Specific Information Card
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 17 Aug 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites
Ankara Bilkent City Hospital
Ankara, Ankara, 06800
erkan yavuz akcaboy, prof. dr., +905054514664, akcaboyyavuz@gmail.com
Sanliurfa Education and Research Hospital
Sanliurfa, Şanlıurfa, 63200
Yağmur Can Dadakçı, +905333599730, yagmurcand@gmail.com
Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sanliurfa, Şanlıurfa, 63300
ahmet cemal kaya, +905393458515, ahmetcemal.kaya@saglik.gov.tr
About this study
Official title: Evaluation of Patient Understanding of Informed Consent Before Interventional Pain Procedures: A Multicenter Randomized Controlled Study
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.
Read the 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.
- Being tested
- Simplified and Visually Supported Procedure-Specific Information Card
- Keywords
- Informed Consent, Patient Understanding, Teach-Back, Interventional Pain Procedures, Patient Education, Simplified Information Materials, Visual Information Materials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simplified and Visually Supported Procedure-Specific Information CardBehavioural
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 group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Intervention Group | Experimental | 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. Receives: Behavioral: Simplified and Visually Supported Procedure-Specific Information Card |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the informed consent process and before the planned clinical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start17 Aug 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Understanding of Informed Consent Before Interventional Pain ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants will be randomly assigned in a 1:1 ratio to either the control group (standard informed consent process only) or the intervention group (standard informed consent process plus a simplified and visually supported procedure-specific information card). Both groups will undergo the standardized teach-back assessment immediately after the consent process and before the clinical procedure. The study will be conducted simultaneously across three centers.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi, Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Responsible party
- Principal investigator, Yağmur Can DADAKÇI, Sanliurfa Education and Research Hospital
- Investigators
- Yağmur Can Dadakçı, Principal investigator, Sanliurfa Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772843
- Sponsor's protocol ID
- HÜ-KAEK-2026-00079
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patient Understanding of Informed Consent Before Interventional Pain Procedures: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07772843
- Acronym / sponsor ID
- HÜ-KAEK-2026-00079
- Keywords
- Informed Consent, Patient Understanding, Teach-Back, Interventional Pain Procedures, Patient Education, Simplified Information Materials, Visual Information Materials
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Collaborators
- T.C. Sağlık Bakanlığı Ankara Bilkent Şehir Hastanesi, Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants will be randomly assigned in a 1:1 ratio to either the control group (standard informed consent process only) or the intervention group (standard informed consent process plus a simplified and visually supported procedure-specific information card). Both groups will undergo the standardized teach-back assessment immediately after the consent process and before the clinical procedure. The study will be conducted simultaneously across three centers.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Intervention Group | Experimental | Behavioral: Simplified and Visually Supported Procedure-Specific Information CardParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simplified and Visually Supported Procedure-Specific Information CardAn 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 | Behavioural | Intervention Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yağmur Can Dadakçı principal investigator
Sanliurfa Education and Research Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simplified and Visually Supported Procedure-Specific Information Card in people with Patient Understanding of Informed Consent Before Interventional Pain Procedures, run by Sanliurfa Education and Research Hospital at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yağmur Can Dadakçı (+905333599730, yagmurcand@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Understanding of Informed Consent Assessed by Teach-Back (time frame: Immediately after the informed consent process and before the planned clinical procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.