NCT07800091

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 27, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2026

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 2, 2026

Completed
Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

July 17, 2026

Last Update Submit

August 29, 2026

Conditions

Keywords

ArthroscopyArtificial IntelligenceSurgical AnxietySurgical FearPostoperative PainPatient Comfort

Outcome Measures

Primary Outcomes (2)

  • 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.

    Exactly 2 hours before the surgery.

  • 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.

    Two hours before surgery.

Study Arms (3)

Artificial Intelligence Education Group

EXPERIMENTAL

Participants will receive a 15-20 minute training session about arthroscopy using an AI-based platform.

Other: Artificial Intelligence-Based Education

Nurse Education Group

ACTIVE COMPARATOR

Participants will receive a 15-20 minute face-to-face training session about arthroscopy provided by the researcher nurse.

Other: Nurse-Led Education

Control Group

OTHER

Participants will receive only the routine hospital information process without any structured training.

Other: Routine Information (Control)

Interventions

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.

Artificial Intelligence Education Group

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.

Nurse Education Group

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

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nigde Omer Halisdemir Education and Research Hospital

Niğde, Turkey (Türkiye)

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nesibe S CINAROGLU, Assistant Professor (PhD)

    Nigde Ömer Halisdemir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 17, 2026

First Posted

September 2, 2026

Study Start

April 27, 2026

Primary Completion

May 29, 2026

Study Completion

August 3, 2026

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations