AnxietyNCT07019688
Anxiety and Information Methods in Molar Extraction
An observational study of Anxiety and Artifical Intelligence, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this clinical study is to investigate the effects of different information methods on patients' anxiety levels during dental procedures under anesthesia. Additionally, the study seeks to evaluate patients' concerns and willingness regarding dental treatment under anesthesia, as well as their awareness of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Artifical Intelligence, Health Communication
- What is being tested?
- Standard Information, Clinician Information and AI Info
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2025to 27 Feb 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consists of adult patients aged 18 to 40 years who are scheduled for the extraction of impacted mandibular molar teeth with a predicted moderate level of difficulty and no anticipated complications. Eligible participants must be systemically healthy, not taking any regular medications, and must have no prior history of sedation, general anesthesia, or surgical removal of impacted molars. Individuals who have previously received verbal, written, or visual information regarding impacted molar extraction will be excluded. Only patients who voluntarily consent to participate and are agreeing to receive preoperative information will be included.
Who may be able to join
- Indication for moderately difficult, non-complicated impacted mandibular molar extraction
- Aged 18-40 years
- No systemic disease or regular medication use
- No previous procedures under sedation or general anesthesia
- No history of impacted molar surgery or complicated extractions
- No prior verbal, written, or visual information on molar extractions
Who cannot join
- Complex or multiple (>2) molar extractions
- Intellectual disability
- Emergency cases
- Refusal to participate or to receive preoperative information
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University, Faculty of Dentistry
Kirikkale
About this study
Official title: Evaluation of Anxiety During Impacted Molar Extraction: The Influence of Verbal, Traditional, and AI-Generated Information Methods on Anesthesia Management
The aim of this clinical study is to investigate the effects of different information methods on patients' anxiety levels during dental procedures under anesthesia. Additionally, the study seeks to evaluate patients' concerns and willingness regarding dental treatment under anesthesia, as well as their awareness of the associated risks.
The main questions this study aims to answer are:
Read more
- How do various information methods influence patients' anxiety levels related to dental procedures under anesthesia?
- What is the relationship between patients' anxiety levels and their awareness of risks associated with dental treatment under anesthesia?
The study hypothesizes that different information methods may vary in their effectiveness at reducing patient stress, and that patients' anxiety levels regarding dental treatment under anesthesia may be associated with their knowledge about potential risks.
Read the detailed description
In this study, questions from 25 patients scheduled for molar tooth extraction will first be collected, and the 20 most frequently asked questions will be identified. The answers to these questions will then be incorporated into routine information procedures. Researchers will prepare verbal, standard written, and written informative materials addressing these questions. To evaluate the impact of artificial intelligence, the identified questions will be submitted to ChatGPT, and the AI-generated responses will be used to create an informational form.
Following the identification of frequently asked questions, newly enrolled patients will be randomly assigned into three groups. Group 1 will receive standard written information, Group 2 will receive clinician-prepared written information containing answers to the identified questions, and Group 3 will receive a written informational form prepared by ChatGPT based on the identified questions. Each group will comprise 35 patients.
Prior to receiving information, participants will complete a baseline survey. Patients will be assigned unique codes, and data including age, gender, educational status, Modified Dental Anxiety Scale (MDAS) scores, and anxiety levels related to dental procedures and anesthesia will be collected. Patients will then receive group-specific information. A follow-up appointment will be scheduled one week later. At this visit, anxiety levels will be reassessed using the MDAS, and additional information will be collected regarding sources consulted for supplementary information (e.g., social media, websites, patient testimonials) and patients' knowledge of anesthesia-related complications. Patients with an MDAS score below 19 will undergo molar tooth extraction under local anesthesia. Those with an MDAS score of 19 or higher will be referred to the anesthesiology faculty member, who also serves as the principal investigator of this study, for the necessary procedures related to dental treatment under anesthesia.
- Conditions
- Anxiety, Artifical Intelligence, Health Communication, Information Dissemination, Decision Support Techniques
- Being tested
- Standard Information, Clinician Information, AI Info
- Keywords
- Dental anxiety, Impacted molar extraction, Patient education, Health communication, Artificial intelligence, Anesthesia-related anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard InformationOther
Participants will receive only the standard written information routinely provided prior to dental procedures. This version does not include any additional content related to frequently asked questions.
Clinician InformationOther
Participants will receive written information prepared by clinicians, which includes responses to the most frequently asked questions collected from patients undergoing same procedures.
AI InfoOther
Participants will receive written information generated by ChatGPT, based on the identified frequently asked questions and formulated specifically for this study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard Info | Participants receive the standard written information routinely provided before molar tooth extraction. Receives: Other: Standard Information | |
| Group 2: Clinician Info | Participants receive written information prepared by clinicians that includes answers to the most frequently asked questions from previous patients. Receives: Other: Clinician Information | |
| Group 3: AI Info | Participants receive written information generated by ChatGPT based on the identified frequently asked questions. Receives: Other: AI Info |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dental Anxiety Level
Change in anxiety levels measured using the Modified Dental Anxiety Scale (MDAS) before and one week after the informational intervention. The primary comparison will assess differences between the three groups receiving different information methods.
Measured: Baseline (pre-information) and 1 week post-information
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start16 Jun 2025
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Nur Erkan, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019688
- Sponsor's protocol ID
- Approval Number: 2025.01.07
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual Participant Data (IPD) will not be publicly available but can be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anxiety During Impacted Molar Extraction: The Influence of Verbal, Traditional, and AI-Generated Information Methods on Anesthesia Management
- ClinicalTrials.gov ID
- NCT07019688
- Acronym / sponsor ID
- Approval Number: 2025.01.07
- Conditions
- Anxiety, Artifical Intelligence, Health Communication, Information Dissemination, Decision Support Techniques
- Keywords
- Dental anxiety, Impacted molar extraction, Patient education, Health communication, Artificial intelligence, Anesthesia-related anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 13 Jun 2025 (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.
The aim of this clinical study is to investigate the effects of different information methods on patients' anxiety levels during dental procedures under anesthesia. Additionally, the study seeks to evaluate patients' concerns and willingness regarding dental treatment under anesthesia, as well as their awareness of the associated risks.
The main questions this study aims to answer are:
- How do various information methods influence patients' anxiety levels related to dental procedures under anesthesia?
- What is the relationship between patients' anxiety levels and their awareness of risks associated with dental treatment under anesthesia?
The study hypothesizes that different information methods may vary in their effectiveness at reducing patient stress, and that patients' anxiety levels regarding dental treatment under anesthesia may be associated with their knowledge about potential risks.
Detailed description
In this study, questions from 25 patients scheduled for molar tooth extraction will first be collected, and the 20 most frequently asked questions will be identified. The answers to these questions will then be incorporated into routine information procedures. Researchers will prepare verbal, standard written, and written informative materials addressing these questions. To evaluate the impact of artificial intelligence, the identified questions will be submitted to ChatGPT, and the AI-generated responses will be used to create an informational form.
Following the identification of frequently asked questions, newly enrolled patients will be randomly assigned into three groups. Group 1 will receive standard written information, Group 2 will receive clinician-prepared written information containing answers to the identified questions, and Group 3 will receive a written informational form prepared by ChatGPT based on the identified questions. Each group will comprise 35 patients.
Prior to receiving information, participants will complete a baseline survey. Patients will be assigned unique codes, and data including age, gender, educational status, Modified Dental Anxiety Scale (MDAS) scores, and anxiety levels related to dental procedures and anesthesia will be collected. Patients will then receive group-specific information. A follow-up appointment will be scheduled one week later. At this visit, anxiety levels will be reassessed using the MDAS, and additional information will be collected regarding sources consulted for supplementary information (e.g., social media, websites, patient testimonials) and patients' knowledge of anesthesia-related complications. Patients with an MDAS score below 19 will undergo molar tooth extraction under local anesthesia. Those with an MDAS score of 19 or higher will be referred to the anesthesiology faculty member, who also serves as the principal investigator of this study, for the necessary procedures related to dental treatment under anesthesia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Standard Info | – | Other: Standard InformationParticipants receive the standard written information routinely provided before molar tooth extraction. |
| Group 2: Clinician Info | – | Other: Clinician InformationParticipants receive written information prepared by clinicians that includes answers to the most frequently asked questions from previous patients. |
| Group 3: AI Info | – | Other: AI InfoParticipants receive written information generated by ChatGPT based on the identified frequently asked questions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consists of adult patients aged 18 to 40 years who are scheduled for the extraction of impacted mandibular molar teeth with a predicted moderate level of difficulty and no anticipated complications. Eligible participants must be systemically healthy, not taking any regular medications, and must have no prior history of sedation, general anesthesia, or surgical removal of impacted molars. Individuals who have previously received verbal, written, or visual information regarding impacted molar extraction will be excluded. Only patients who voluntarily consent to participate and are agreeing to receive preoperative information will be included.
Key inclusion criteria (6 listed)
- Indication for moderately difficult, non-complicated impacted mandibular molar extraction
- Aged 18-40 years
- No systemic disease or regular medication use
- No previous procedures under sedation or general anesthesia
- No history of impacted molar surgery or complicated extractions
Key exclusion criteria (4 listed)
- Complex or multiple (>2) molar extractions
- Intellectual disability
- Emergency cases
- Refusal to participate or to receive preoperative information
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 |
|---|---|---|
| Standard InformationParticipants will receive only the standard written information routinely provided prior to dental procedures. This version does not include any additional content related to frequently asked questions. | Other | Group 1: Standard Info |
| Clinician InformationParticipants will receive written information prepared by clinicians, which includes responses to the most frequently asked questions collected from patients undergoing same procedures. | Other | Group 2: Clinician Info |
| AI InfoParticipants will receive written information generated by ChatGPT, based on the identified frequently asked questions and formulated specifically for this study. | Other | Group 3: AI Info |
Primary outcome
Change in Dental Anxiety Level
Time frame: Baseline (pre-information) and 1 week post-information
Change in anxiety levels measured using the Modified Dental Anxiety Scale (MDAS) before and one week after the informational intervention. The primary comparison will assess differences between the three groups receiving different information methods.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No. The Individual Participant Data (IPD) will not be publicly available but can be shared upon reasonable request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Artifical Intelligence, run by Kırıkkale 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 17 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dental Anxiety Level (time frame: Baseline (pre-information) and 1 week post-information). 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 17 Mar 2026.