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ArthroscopyNCT07800091

The Effect of AI Training on Arthroscopy Outcomes

A study testing Artificial Intelligence-Based Education and Nurse-Led Education in people with Arthroscopy and Artificial Intelligence (AI), run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is planned to determine the effects of AI-assisted regional training on surgical anxiety, fear, postoperative pain, and comfort levels in patients undergoing arthroscopy. It will be designed as a prospective, observational, and intervention-based clinical trial. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Artificial Intelligence-Based Education and Nurse-Led Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteTurkey (Türkiye)
Study dates
27 Apr 2026to 3 Aug 2026
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients scheduled for arthroscopic surgery,
  • Individuals aged 18 and older who are scheduled to undergo elective (planned) surgery,
  • Individuals with the cognitive ability to understand artificial intelligence-based educational materials,
  • Patients who voluntarily agreed to participate in the study and provided informed consent were considered eligible.

Who cannot join

  • -Individuals with psychiatric disorders or a diagnosis of anxiety disorder,
  • Patients unable to access the educational materials for the following reasons:
  • Visual or hearing impairments,
  • Conditions requiring emergency surgery.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Nigde Omer Halisdemir Education and Research Hospital

    Niğde

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of AI-Based Training Before Arthroscopy on Surgical Anxiety, Fear, Postoperative Pain, and Comfort Levels: A Randomized Controlled Study

This study is planned to determine the effects of AI-assisted regional training on surgical anxiety, fear, postoperative pain, and comfort levels in patients undergoing arthroscopy. It will be designed as a prospective, observational, and intervention-based clinical trial. Necessary ethical and institutional permissions will be obtained before the start of the research. Ethical Approvals and Permissions were obtained from the Niğde Ömer Halisdemir University Ethics Committee, Niğde Provincial Health Directorate, and Ömer Halisdemir Training and Research Hospital. The participants are adult patients undergoing arthroscopy surgery. Informed consent will be obtained for participation in the study. Intervention: AI-assisted regional training will be applied before arthroscopy. Data Collection Tools: Pre-Assessment Form, Personal Information Form, Surgical Fear Scale, Surgical Anxiety Scale for Adult Patients, Postpartum Comfort Scale, and Perianesthesia Comfort Scale will be used. Data Analysis: Data will be evaluated using the IBM SPSS Statistics 24 software package. Appropriate statistical analysis methods will be used.

Read the detailed description

Arthroscopy has significantly increased the variety of procedures that can be performed in orthopedic surgery, reducing both morbidity and hospital stay. Initially used only in knee surgeries, it has expanded over time to include other areas such as the shoulder, elbow, wrist, hip, ankle, and foot joints. Thanks to advanced surgical instruments, many procedures previously only possible with open surgery can now be performed arthroscopically. The repertoire of these methods is constantly expanding, and it has become one of the most frequently performed orthopedic procedures today. Undergoing a medical or surgical procedure under anesthesia is an unusual experience for most patients. Facing this situation can cause varying levels of preoperative anxiety. High levels of anxiety can lead to emotional and physical stress responses, affecting the patient's postoperative outcomes and delaying their discharge. Even though arthroscopic surgery is a closed, minimally invasive procedure, patients may experience anxiety due to the possibility of difficulty waking up after surgery, pain, work-life difficulties, disability, loss of control over part or all of their body, or delayed healing, depending on the type of anesthesia to be administered. Studies have shown that 60-80% of patients scheduled for surgical intervention experience anxiety before surgery. Furthermore, it is known that the inability to control preoperative anxiety and fear levels increases the need for anesthesia, and after surgery, increases the need for analgesics and the rate of complications. Studies suggest that the severity of postoperative pain affects the patient's anxiety level. Anxiety caused by pain affects the individual perceptually, behaviorally, cognitively, psychologically, and physiologically. As a result of these effects, respiratory rate, blood pressure, and heart rate increase. Sweating, shivering, headache, dizziness, fainting, insomnia, fatigue, dry mouth, nausea, vomiting, difficulty swallowing, loss of appetite, diarrhea, constipation, muscle tension, and frequent urination may occur. Although surgery aims to improve health, it is traumatic for the patient in social, physiological, and psychological terms. Ensuring and maintaining comfort in patients undergoing surgery should be among the goals of care. In this way, the patient can feel more comfortable, at ease, and empowered to overcome problems.It is considered normal for patients to experience anxiety before and after surgery. However, high levels of anxiety and uncontrolled anxiety can lead to problems and complications during both pre- and post-operative periods. Many methods are used to reduce anxiety and strengthen individuals' ability to cope with it in the pre-operative period, including information sessions, music therapy, acupuncture, aromatherapy, acupressure, physical exercise, cognitive behavioral therapy, meditation, relaxation exercises, massage, and breathing exercises. Methods used to reduce anxiety aim to relax the individual physically and mentally and improve their anxiety management skills. Nurses provide patient education or information about the surgery to alleviate the patient's anxiety and fear before the procedure. Preoperative education content should include information on the preparation process for surgery, preoperative medications and expected procedures, the postoperative period, postoperative pain management, and anxiety management skills.Researchers investigating the effect of information on pain in spinal surgery report that adequate preoperative information reduces pain sensation. Studies indicate that different types of information, depending on the extent of the surgery, are effective in managing surgical anxiety and postoperative pain in patients scheduled for surgery. The value of preoperative information in postoperative management has increased the use of the internet, which is now a source of information for everyone. This study aims to determine the effect of providing preoperative information and education with artificial intelligence on preoperative anxiety, fear, and postoperative pain and comfort levels.

Being tested
Artificial Intelligence-Based Education, Nurse-Led Education, Routine Information (Control)
Keywords
Arthroscopy, Artificial Intelligence, Surgical Anxiety, Surgical Fear, Postoperative Pain, Patient Comfort
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artificial Intelligence-Based EducationOther

    Artificial Intelligence-Based Education (Experimental): Participants will attend an AI-assisted training program prior to arthroscopy. The training will be delivered digitally, covering the stages of the surgical procedure, anxiety and fear management techniques, and comfort-enhancing information. This intervention, unlike nurse training and the control group, is administered through a technological platform.

  • Nurse-Led EducationOther

    Nurse-Led Education (Active Comparator): Participants will attend a standard face-to-face training program given by a nurse prior to arthroscopy. The training will cover the explanation of the surgical procedure, methods for coping with anxiety and fear, and post-operative care. This intervention, unlike the AI-based training, is administered directly by a healthcare professional.

  • Routine Information (Control)Other

    Control (Control Arm): Participants will not receive any special training prior to arthroscopy; only a routine information process will be applied. This group will be used for comparison with AI and nurs

Study groups in NCT07800091
Study groupRoleWhat they receive
Artificial Intelligence Education GroupExperimentalParticipants will receive a 15-20 minute training session about arthroscopy using an AI-based platform.
Receives: Other: Artificial Intelligence-Based Education
Nurse Education GroupActive comparatorParticipants will receive a 15-20 minute face-to-face training session about arthroscopy provided by the researcher nurse.
Receives: Other: Nurse-Led Education
Control GroupOtherParticipants will receive only the routine hospital information process without any structured training.
Receives: Other: Routine Information (Control)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Anxiety Level Assessed by Surgical Anxiety Questionnaire (SAQ)

    The scale was used to determine the level of anxiety of patients who will undergo surgical intervention. The sub-dimensions of the scale are health-related anxieties (7th, 9th, 10th, 11th, 12th, and 13th items), recovery-related anxieties (14th, 15th, 16th, and 17th items), surgical procedure-related anxieties (1st, 2nd, 4th, and 8th items) and invasive procedure-related anxieties (3rd, 5th, and 6th items). Scoring of the scale items is made as 0 = 'not at all anxious,' 1 = 'very little anxious,' 2 = 'somewhat anxious,' 3 = 'very anxious,' and 4 = 'extremely anxious.' There are no reverse items on the scale. Total and sub-dimension scores are calculated by adding the items they contain. The lowest score that can be obtained from the scale is 0, and the highest score is 68. The scale has no cut-off point, and high scores indicate that the anxiety level of the patients is high.

    Measured: Exactly 2 hours before the surgery.

  2. Surgical Fear Level Assessed by Surgical Fear Questionnaire (SFQ)

    The Surgical Fear Scale was developed by Theunissen et al. in 2014, and its Turkish validity and reliability study was conducted by Bağdigen and Karaman Özlü in 2018. The scale consists of 8 items scored on an 11-point Likert scale ranging from 0 ("I am not afraid at all") to 10 ("I am very afraid"), and is designed to assess fear related to surgery. It comprises two sub-dimensions measuring fear of the short-term and long-term consequences of surgical procedures. The total scale score ranges from 0 to 80, and the subscale scores range from 0 to 40, with higher scores indicating a higher level of surgical fear.

    Measured: Two hours before surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start27 Apr 2026
  3. Primary completion29 May 2026
  4. Study completion3 Aug 2026

Resources

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
Model description
After meeting at the Orthopedics Department of Niğde Ömer Halisdemir University Training and Research Hospital before the arthroscopy procedure, the patient's suitability for inclusion in the study will be evaluated by applying the "Preliminary Evaluation Form". Patients in the groups will be informed about the procedure to be followed, and their verbal and written consent will be obtained by reading the voluntary information form. Arm 1: AI Training Group * Type: Experimental * Description: Patients receive a 15-20 minute individual training session conducted via an AI-based platform. Arm 2: Nurse Training Group * Type: Experimental * Description: Patients receive a 15-20 minute individual training session conducted by a professional nurse. Arm 3: Control Group * Type: No Intervention / Standard Care * Description: Patients receive standard perioperative nursing care without any additional structured training session.
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800091
Sponsor's protocol ID
27/06/2025-671900
Status last verified
Aug 2026
First submitted
17 Jul 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Friedrich, S., Reis, S., Meybohm, P., Kranke, P. (2022). Preoperative anxiety. Current Opinion in Anaesthesiology, 35(6), 674-678. https://doi.org/10.1097/ACO.0000000000001186 Dayılar, CH., Çelik, YG., Kamer, E., Sarıçiçek, a., Cengiz, F., Hacıyanlı, M. (2017) Evaluation of anxiety levels of patients before colon surgery. Turk J Colorectal Dis, 27, 6-10. Karadağ, A. Ş. (2017). Ameliyat öncesi anksiyetenin APAIS ve STAI-I ölçekleri ile değerlendirilmesi. Hacettepe Üniversitesi Hemşirelik Fakültesi Dergisi, 4, (3), 38-47. Taşdemir, A., Erakgün, A., Deniz, N. M., Çertuğ, A. (2013). Comparison of Preoperative and Postoperative Anxiety Levels with State-Trait Anxiety Inventory Test in Preoperatively Informed Patients. Turkish J Anaesth Reanim, 41, 44-49. Öztürk D., Aldemir, K. A. (2024). "The Relationship Between Adult Patients' Preoperative Perceived Social Support and Surgical Anxiety: A Descriptive Study", Turkiye Klinikleri J Nurs Sci.;16(1):26-34 doi: 10.5336/nurses.2023-99645 Vaughn F., Wichowski, H., Bosworth, G. (2007). Does preoperative anxiety level predict postoperative pain. AORN, 3, 589- 594. Mitchell, MJ. (2009). Patient anxiety and conscious surgery. Journal of Perioperative Practice, 19, 168- 173. Vaajoki, A., Pietila, AM., Kankkunen, P., Vehvilainen, JK. (2012). Effects of listening to music on pain intensity and pain distress after surgery: an intervention. J Clin Nurs, 21, 708- 717. Rajareddy, G.V., Shetty, A.B., Santhosh, C.S., Kumar, P., Kumar, S., Manangi, M. (2023). A randomized controlled trial to assess the impact of ERAS (Enhanced recovery after surgery) on Laparoscopic Cholecystectomy. International Journal of Surgery and Medicine, 9(1), 15-15. Abdullayev, A., Ozbas, A. (2021). "The effect of foot massage on pain and anxiety levels after laparoscopic cholecystectomy: a randomized-controlled trial " Clinical and Experimental Health Sciences 11(4): 746-753. Villar RN. Arthroscopy. BMJ. 1994 Jan 1;308(6920):51-3. doi: 10.1136/bmj.308.6920.51. PMI

Questions about this trial

What is this clinical trial studying?

A study testing Artificial Intelligence-Based Education and Nurse-Led Education in people with Arthroscopy and Artificial Intelligence (AI), run by Nigde Omer Halisdemir 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 4 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 2 Sep 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?

Surgical Anxiety Level Assessed by Surgical Anxiety Questionnaire (SAQ) (time frame: Exactly 2 hours before the surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07800091, which also lists 1 linked publication.

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 2 Sep 2026.

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