Minor Trauma Requiring SuturingNCT07872215
AI-Assisted Patient Education Before Suturing in Minor Trauma
A study testing AI-Assisted Pre-Suturing Patient Education in people with Minor Trauma Requiring Suturing and Pain, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Patients scheduled to undergo suturing for minor trauma in the emergency department frequently experience anticipatory pain and anxiety before the procedure. These experiences may negatively affect perceived pain, cooperation with treatment, adherence, satisfaction, and the overall care experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Minor Trauma Requiring Suturing, Pain, Anxiety
- What is being tested?
- AI-Assisted Pre-Suturing Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 30 Jun 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with minor trauma requiring suturing, including superficial lacerations of the hand, arm, foot, leg, head, or face
- Patients who provide written informed consent to participate in the study
- Patients aged 18 years or older
- Patients who are able to read and write
- Patients without communication difficulties
Who cannot join
- Patients requiring emergency surgical intervention, such as those with traumatic amputation or lacerations requiring urgent operative management
- Patients with communication barriers that prevent participation in the study
- Patients who are unable to read and write
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Provincial Health Directorate Ankara Training And Research Hospital, Adult Emergency Department
Ankara, 06230
Rabia ÇİBİK, Nurse, +90 531 545 32 94, rabiacibikk@gmail.com
Nevra KALKAN, PhD, nevra.demir@gazi.edu.tr
About this study
Official title: Effect of Artificial Intelligence-Assisted Pre-Suturing Patient Education on Pain and Anxiety in Patients With Minor Trauma in the Emergency Department
Patients scheduled to undergo suturing for minor trauma in the emergency department frequently experience anticipatory pain and anxiety before the procedure. These experiences may negatively affect perceived pain, cooperation with treatment, adherence, satisfaction, and the overall care experience. However, the realities of emergency department practice, including crowding, high patient volume, staff shortages, and increased workload, may limit effective nurse-patient communication and comprehensive patient education.
Patients awaiting suturing for minor trauma often experience uncertainty, prolonged waiting, fear of the procedure, and concern about pain. These factors may increase anxiety, which can further intensify pain perception and negatively influence patients' cooperation with treatment and satisfaction with care. Previous reports indicate that many patients waiting in emergency departments seek information about waiting times, care processes, and their medical conditions, highlighting a substantial need for accessible and reliable information.
Read more
During this waiting period, patients may increasingly use artificial intelligence-based digital resources to obtain information about their health condition and the procedure they are about to undergo. However, information generated by artificial intelligence may be inaccurate, incomplete, or insufficiently tailored to the clinical context. Therefore, such information should be reviewed and validated by healthcare professionals before being provided to patients.
This study aims to evaluate the effect of an artificial intelligence-assisted patient education material delivered during the pre-suturing waiting period on pain and anxiety levels among patients with minor trauma in the emergency department. It is also expected that the educational material developed within the scope of this study may contribute to patient education and supportive care in emergency department settings.
- Conditions
- Minor Trauma Requiring Suturing, Pain, Anxiety
- Being tested
- AI-Assisted Pre-Suturing Patient Education
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Pre-Suturing Patient EducationBehavioural
The intervention consists of an AI-assisted patient education material provided to patients with minor trauma during the waiting period before suturing in the emergency department. The educational content includes information about the purpose and steps of the suturing procedure, what patients may experience during the procedure, pain-related expectations, and measures intended to reduce uncertainty and anxiety before suturing. The educational material is developed with the assistance of artificial intelligence. All AI-assisted content is reviewed, clinically evaluated, and validated by healthcare professionals before being presented to participants to ensure accuracy, appropriateness, and consistency with clinical practice. Participants receive the educational intervention in addition to routine emergency department care before the suturing procedure.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Pre-Suturing Patient Education | Experimental | Participants assigned to the intervention group will receive an AI-assisted patient education material during the waiting period before suturing. The educational material provides information about the suturing procedure, expected sensations, pain-related concerns, and the procedural process. Content generated with the assistance of artificial intelligence will be reviewed and validated by healthcare professionals before being provided to participants. In addition to the educational intervention, participants will receive routine emergency department care. Receives: Behavioral: AI-Assisted Pre-Suturing Patient Education |
| Standard Care | No intervention | Participants assigned to the control group will receive routine emergency department care before suturing. No AI-assisted patient education material or additional structured educational intervention will be provided as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Level Assessed Using the State-Trait Anxiety Inventory Form TX-1 (STAI Form TX-1)
State anxiety will be assessed using the State-Trait Anxiety Inventory Form TX-1 (STAI Form TX-1). The scale evaluates the participant's current level of anxiety. Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
Measured: Baseline before allocation disclosure (T0), pre-suturing after the intervention or usual-care period (T1), and immediately after completion of the suturing procedure (T2)
Change in Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will indicate the intensity of their current pain on the scale, with higher scores indicating greater pain intensity.
Measured: Baseline before allocation disclosure (T0), pre-suturing after the intervention or usual-care period (T1), and immediately after completion of the suturing procedure (T2)
Change in Pain Assessed Using the Short-Form McGill Pain Questionnaire
Pain will also be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), which evaluates multiple dimensions of the pain experience, including sensory and affective characteristics. Higher scores indicate greater pain severity.
Measured: Baseline before allocation disclosure (T0), pre-suturing after the intervention or usual-care period (T1), and immediately after completion of the suturing procedure (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor Trauma Requiring SuturingStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevra KALKAN, Gazi University
- Investigators
- Nevra KALKAN, Principal investigator, Gazi UniversityRabia ÇİBİK, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872215
- Sponsor's protocol ID
- GU-ED-RCT-2026-01
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Intelligence-Assisted Pre-Suturing Patient Education on Pain and Anxiety in Patients With Minor Trauma in the Emergency Department
- ClinicalTrials.gov ID
- NCT07872215
- Acronym / sponsor ID
- GU-ED-RCT-2026-01
- Conditions
- Minor Trauma Requiring Suturing, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Oct 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.
Patients scheduled to undergo suturing for minor trauma in the emergency department frequently experience anticipatory pain and anxiety before the procedure. These experiences may negatively affect perceived pain, cooperation with treatment, adherence, satisfaction, and the overall care experience. However, the realities of emergency department practice, including crowding, high patient volume, staff shortages, and increased workload, may limit effective nurse-patient communication and comprehensive patient education.
Patients awaiting suturing for minor trauma often experience uncertainty, prolonged waiting, fear of the procedure, and concern about pain. These factors may increase anxiety, which can further intensify pain perception and negatively influence patients' cooperation with treatment and satisfaction with care. Previous reports indicate that many patients waiting in emergency departments seek information about waiting times, care processes, and their medical conditions, highlighting a substantial need for accessible and reliable information.
During this waiting period, patients may increasingly use artificial intelligence-based digital resources to obtain information about their health condition and the procedure they are about to undergo. However, information generated by artificial intelligence may be inaccurate, incomplete, or insufficiently tailored to the clinical context. Therefore, such information should be reviewed and validated by healthcare professionals before being provided to patients.
This study aims to evaluate the effect of an artificial intelligence-assisted patient education material delivered during the pre-suturing waiting period on pain and anxiety levels among patients with minor trauma in the emergency department. It is also expected that the educational material developed within the scope of this study may contribute to patient education and supportive care in emergency department settings.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Pre-Suturing Patient Education | Experimental | Behavioral: AI-Assisted Pre-Suturing Patient EducationParticipants assigned to the intervention group will receive an AI-assisted patient education material during the waiting period before suturing. The educational material provides information about the suturing procedure, expected sensations, pain-related concerns, and the procedural process. Content generated with the assistance of artificial intelligence will be reviewed and validated by healthcare professionals before being provided to participants. In addition to the educational intervention, participants will receive routine emergency department care. |
| Standard Care | No intervention | –Participants assigned to the control group will receive routine emergency department care before suturing. No AI-assisted patient education material or additional structured educational intervention will be provided as part of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with minor trauma requiring suturing, including superficial lacerations of the hand, arm, foot, leg, head, or face
- Patients who provide written informed consent to participate in the study
- Patients aged 18 years or older
- Patients who are able to read and write
- Patients without communication difficulties
Key exclusion criteria (3 listed)
- Patients requiring emergency surgical intervention, such as those with traumatic amputation or lacerations requiring urgent operative management
- Patients with communication barriers that prevent participation in the study
- Patients who are unable to read and write
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 |
|---|---|---|
| AI-Assisted Pre-Suturing Patient EducationThe intervention consists of an AI-assisted patient education material provided to patients with minor trauma during the waiting period before suturing in the emergency department. The educational content includes information about the purpose and steps of the suturing procedure, what patients may experience during the procedure, pain-related expectations, and measures intended to reduce uncertainty and anxiety before suturing. The educational material is developed with the assistance of artificial intelligence. All AI-assisted content is reviewed, clinically evaluated, and validated by healthcare professionals before being presented to participants to ensure accuracy, appropriateness, and consistency with clinical practice. Participants receive the educational intervention in addition to routine emergency department care before the suturing procedure. | Behavioural | AI-Assisted Pre-Suturing Patient Education |
Primary outcome
Change in State Anxiety Level Assessed Using the State-Trait Anxiety Inventory Form TX-1 (STAI Form TX-1)
Time frame: Baseline before allocation disclosure (T0), pre-suturing after the intervention or usual-care period (T1), and immediately after completion of the suturing procedure (T2)
State anxiety will be assessed using the State-Trait Anxiety Inventory Form TX-1 (STAI Form TX-1). The scale evaluates the participant's current level of anxiety. Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
Change in Pain Intensity Assessed Using the Visual Analog Scale (VAS)
Time frame: Baseline before allocation disclosure (T0), pre-suturing after the intervention or usual-care period (T1), and immediately after completion of the suturing procedure (T2)
Pain intensity will be assessed using the Visual Analog Scale (VAS). Participants will indicate the intensity of their current pain on the scale, with higher scores indicating greater pain intensity.
Change in Pain Assessed Using the Short-Form McGill Pain Questionnaire
Time frame: Baseline before allocation disclosure (T0), pre-suturing after the intervention or usual-care period (T1), and immediately after completion of the suturing procedure (T2)
Pain will also be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), which evaluates multiple dimensions of the pain experience, including sensory and affective characteristics. Higher scores indicate greater pain severity.
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 13 Oct 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.
Nevra KALKAN principal investigator
Gazi University
Rabia ÇİBİK study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Assisted Pre-Suturing Patient Education in people with Minor Trauma Requiring Suturing and Pain, run by Gazi University at 1 site 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 3 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Rabia ÇİBİK, Nurse (+90 531 545 32 94, rabiacibikk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State Anxiety Level Assessed Using the State-Trait Anxiety Inventory Form TX-1 (STAI Form TX-1) (time frame: Baseline before allocation disclosure (T0), pre-suturing after the intervention or usual-care period (T1), and immediately after completion of the suturing procedure (T2)). The study lists 3 primary outcomes in all. 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 13 Oct 2026.