Nigde Omer Halisdemir Education and Research Hospital
Niğde, Turkey (Türkiye)
NCT Number: NCT07800091
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Niğde, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-Individuals with psychiatric disorders or a diagnosis of anxiety disorder,
Patients unable to access the educational materials for the following reasons:
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 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.
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
Time frame: Exactly 2 hours before the surgery.
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.
Time frame: Two hours before surgery.
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.
Nigde Omer Halisdemir University
Other
The Effect of AI-Based Training Before Arthroscopy on Surgical Anxiety, Fear, Postoperative Pain, and Comfort Levels: A Randomized Controlled Study
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