[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658898":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":50,"interventions":61,"overallOfficials":39,"centralContacts":67,"locations":73,"responsibleParty":89,"collaborators":39,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":39,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":39,"enrollmentInfo":102,"targetDuration":39,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":118,"whyStopped":39,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Ataturk University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":39},[9],{"measure":10,"description":11,"timeFrame":12},"State Anxiety","State anxiety is assessed using the State Anxiety Inventory (STAI Form TX-1), developed by Spielberger et al. The scale consists of 20 items designed to measure situational\u002Ftransient anxiety. Each item is rated on a 4-point Likert scale ranging from 1 (\"not at all\") to 4 (\"very much so\"). Total scores range from 20 to 80, with higher scores indicating greater levels of acute anxiety.","Preoperatively (baseline, in the waiting area before surgery) and postoperatively (10 minutes after transfer to the ward following surgery)",[14,18,22,26,30,33,36],{"measure":15,"description":16,"timeFrame":17},"Postoperative Pain","Pain intensity is assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (\"no pain\") to 10 (\"worst possible pain\"). Participants select the number that best represents their current pain level. Higher scores indicate greater pain severity.","Postoperatively (10 minutes after transfer to the ward following surgery)",{"measure":19,"description":20,"timeFrame":21},"Intraoperative Patient Compliance and Surgeon Evaluation Score","Evaluated immediately post-surgery by the operating surgeon, who is blinded to participant group allocation, using a 4-item questionnaire on a 5-point Likert scale (1 = most negative to 5 = most positive). The scale assesses speed and accuracy of response to commands, eye fixation quality, involuntary head\u002Feye movements, and overall surgical facilitation\u002Fcomfort. Total scores range from 4 to 20, with higher scores indicating superior intraoperative compliance and surgical ease.","Immediately at the end of surgery (before the patient leaves the operating table)",{"measure":23,"description":24,"timeFrame":25},"Total Operation Duration","Total surgical procedure duration measured objectively in minutes, recorded from the initial incision to the completion of the final surgical suture.","At the completion of the surgical procedure (recorded immediately post-surgery)",{"measure":27,"description":28,"timeFrame":29},"Systolic and Diastolic Blood Pressure","Systolic and diastolic blood pressure measured in millimeters of mercury (mmHg) using a calibrated clinical monitor to evaluate hemodynamic stability.","Baseline (preoperative waiting area), intraoperatively (during surgery), and postoperatively (10 minutes after transfer to the ward)",{"measure":31,"description":32,"timeFrame":29},"Heart Rate","Heart rate measured in beats per minute (bpm) via continuous clinical monitoring to evaluate autonomic response.",{"measure":34,"description":35,"timeFrame":29},"Respiratory Rate","Respiratory rate measured in breaths per minute via clinical observation\u002Fmonitoring.",{"measure":37,"description":38,"timeFrame":29},"Peripheral Oxygen Saturation (SpO2)","Peripheral oxygen saturation measured as a percentage (%) using a pulse oximeter.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":43,"primaryPurpose":44,"observationalModel":39,"timePerspective":39,"maskingInfo":45},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to two parallel groups: the Video-Assisted Education and Eye Fixation Training Group (n = 76) and the Routine Care Control Group (n = 76).","SUPPORTIVE_CARE",{"masking":46,"maskingDescription":47,"whoMasked":48},"SINGLE","Due to the nature of the educational and training intervention, participants and the researcher administering the module cannot be masked. However, the operating surgeon who evaluates intraoperative patient compliance and surgical comfort using the Intraoperative Patient Compliance and Surgeon Evaluation Form will be blinded to the participants' group allocation.",[49],"OUTCOMES_ASSESSOR",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Video-Assisted Education","EXPERIMENTAL","Participants in this group (n = 76) will receive an 8-to-10-minute two-stage audiovisual surgical preparation module on a tablet prior to pterygium surgery, in addition to routine clinical care. Stage 1 provides ERAS-based cognitive preparation (2D animation of pterygium and local anesthesia, audiovisual desensitization to operating room lights and monitor sounds, and postoperative care rules). Stage 2 provides interactive eye position fixation and motor compliance training (dynamic gaze tracking of a moving red target followed by static gaze fixation exercises lasting 1 to 3 minutes).",[56],"Behavioral: Video-Assisted Patient Education",{"label":58,"type":59,"description":60,"interventionNames":39},"Routine Preoperative Care Group","NO_INTERVENTION","Participants in this group (n = 76) will receive standard routine verbal preoperative information provided by the ward nurse (surgery time, fasting status, and general process) without any video-assisted education or eye fixation training.",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":39},"BEHAVIORAL","Video-Assisted Patient Education","An 8-to-10-minute two-stage audiovisual preparation module administered on a standard tablet prior to pterygium surgery. Stage 1 involves ERAS-based cognitive preparation, including 2D animations of pterygium surgery and local anesthesia, audiovisual desensitization to operating room lights and monitor beeps, and postoperative eye care instructions. Stage 2 consists of interactive eye fixation and motor compliance training, where participants follow voice prompts to track a moving red target without moving their heads, followed by static gaze fixation exercises held for 1 to 3 minutes to improve intraoperative surgical compliance.",[52],[68],{"name":69,"role":70,"phone":71,"phoneExt":39,"email":72},"Mehmet Günay Uyar, PhD","CONTACT","+905543488391","mehmet.uyar@erzincan.edu.tr",[74],{"facility":75,"status":39,"city":76,"state":77,"zip":78,"country":79,"countryCode":39,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Erzincan Binali Yildirim University Mengucek Gazi Training and Research Hospital","Erzincan","Merkez","24000","Turkey (Türkiye)",{"type":81,"coordinates":82},"Point",[83,84],39.49015,39.73919,{"lat":84,"lon":83},[87],{"name":88,"role":70,"phone":71,"phoneExt":39,"email":72},"Mehmet Günay Uyar",{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Mehmet Gunay Uyar","Assistant Professor","100658898","video-assisted-patient-education-and-eye-fixation-training-in-pterygium-surgery-100658898",false,"NCT07858045","Video-Assisted Patient Education and Eye Fixation Training in Pterygium Surgery","The Effect of Video-Assisted Eye Position Fixation and Patient Education on Anxiety, Pain, Intraoperative Compliance, and Physiological Parameters in Pterygium Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged between 18 and over\n* Diagnosed with primary pterygium scheduled for surgical excision with conjunctival autograft under local anesthesia\n* American Society of Anesthesiologists (ASA) physical status class I or II\n* Ability to read, understand, and communicate in Turkish\n* Voluntary agreement to participate in the study with written informed consent\n\nExclusion Criteria:\n\n* Requirement for general anesthesia\n* History of psychiatric illness or regular use of anxiolytic\u002Fpsychotropic medications\n* Severe visual impairment in the contralateral eye or severe hearing impairment interfering with communication\n* History of prior major ocular surgery in the study eye or contralateral eye\n* Presence of systemic comorbidities including diabetes mellitus, severe respiratory diseases, or significant cardiovascular diseases\n* Cancellation of surgery due to technical or medical reasons\n* Withdrawal of consent or request to leave the study at any stage","ALL","18 Years",{"count":103,"type":104},152,"ESTIMATED","INTERVENTIONAL",[107],"NA","This randomized controlled trial aims to investigate the effects of preoperative video-assisted patient education combined with eye position fixation training on anxiety, pain, intraoperative compliance, operation duration, and physiological parameters in adult patients undergoing primary pterygium surgery under local anesthesia. A total of 152 patients aged 18 to 75 years scheduled for primary pterygium excision with conjunctival autograft will be randomly assigned to either the intervention group (n = 76) or the control group (n = 76). Patients in the intervention group will receive an 8-to-10-minute tablet-based audiovisual surgical preparation module prior to surgery. This module consists of two stages: (1) cognitive preparation based on Enhanced Recovery After Surgery (ERAS) principles, including 2D animations of the procedure, desensitization to operating room sights and sounds, and postoperative care instructions; and (2) interactive eye position fixation and motor compliance training. Patients in the control group will receive standard routine verbal preoperative information. Anxiety levels, pain intensity, and physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) will be assessed preoperatively and postoperatively. Intraoperative patient compliance and surgical comfort will be evaluated immediately after surgery by a blinded surgeon, along with total operation duration and intraoperative physiological parameters.",[110,111,15],"Pterygium","Preoperative Anxiety",[113,114,115,116,117],"Pterygium surgery","Video-assisted patient education","Eye position fixation training","Enhanced Recovery After Surgery","Physiological parameters","NOT_YET_RECRUITING","2026-10-02",{"date":121,"type":122},"2026-10-05","ACTUAL",{"date":124,"type":104},"2026-10-12",{"date":126,"type":104},"2027-10-15",{"name":5,"class":6},1]