[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594241":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":35,"responsibleParty":56,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hacettepe University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual Reality Group","EXPERIMENTAL","Participants in this group will receive a virtual reality intervention before surgery. Anxiety, physiological parameters, and satisfaction will be assessed both before and after the VR session.",[13],"Behavioral: Virtual Reality Relaxation Session",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Care Group","NO_INTERVENTION","Participants in this group will receive standard preoperative care. The same measurements will be taken before and after standard care.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Virtual Reality Relaxation Session","A 20 minute virtual reality session using visual and auditory stimuli for relaxation before surgery. Delivered via VR headset.",[9],[26],{"name":27,"affiliation":28,"role":29},"Fatma Uslu Sahan, Assoc Prof","Hacettepe University Faculty of Nursing","PRINCIPAL_INVESTIGATOR",[31],{"name":27,"role":32,"phone":33,"phoneExt":18,"email":34},"CONTACT","+90 534 224 59 80","fatma.uslu@hacettepe.edu.tr",[36],{"facility":5,"status":37,"city":38,"state":18,"zip":39,"country":40,"countryCode":18,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Ankara","06100","Turkey (Türkiye)",{"type":42,"coordinates":43},"Point",[44,45],32.85427,39.91987,{"lat":45,"lon":44},[48,52],{"name":49,"role":32,"phone":50,"phoneExt":18,"email":51},"Melike Sahingöz, PhD Student","+90 545 375 64 94","melike.shngz@gmail.com",{"name":53,"role":32,"phone":54,"phoneExt":18,"email":55},"Ozhan Ozdemir, Professor","+90 505 225 50 78","ozhan.ozdemir@saglik.gov.tr",{"type":29,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Fatma Uslu Sahan","Associate professor","100594241","anxiety-physiological-parameters-patient-satisfaction-and-vr-in-gynecological-oncology-surgery-100594241",false,"NCT07016880","Anxiety, Physiological Parameters, Patient Satisfaction and VR in Gynecological Oncology Surgery","The Effect of Virtual Reality Intervention on Preoperative Anxiety, Physiological Parameters and Patient Satisfaction in Women Scheduled for Gynecological Oncology Surgery: A Randomised Controlled Trial","Inclusion Criteria:\n\n* The participant must have a confirmed diagnosis of gynecological cancer.\n* The participant must be aware of their gynecological cancer diagnosis.\n* Participants must be 18 years of age or older.\n* Verbal and written informed consent to participate in the study must be obtained.\n* The participant must be able to communicate verbally and in writing in Turkish.\n* No communication impairments (e.g., visual, auditory, or cognitive) should be present.\n* This must be the participant's first surgical intervention related to gynecological oncology.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status must not exceed 2.\n* The planned surgical procedure must be a laparotomy.\n\nExclusion Criteria:\n\n* History of recurrent gynecological cancer.\n* Presence of vision problems that prevent the use of VR goggles, including participants who wear glasses or have uncorrected vision impairment.\n* Presence of conditions such as migraines, vertigo, active nausea, vomiting, or frequent headaches.\n* Sensitivity to motion sickness.\n* Diagnosis of a psychiatric condition, whether under pharmacological or non-pharmacological treatment.\n* Withdrawal of consent during the study.\n* Removal of the virtual reality headset during the intervention.\n* Development of any medical complications during the intervention period.","FEMALE","18 Years",{"count":69,"type":70},66,"ESTIMATED","INTERVENTIONAL",[73],"NA","Surgical procedures often cause significant anxiety in patients, particularly among women undergoing gynecological oncology surgeries. Preoperative anxiety is a common and preventable condition that can negatively affect both physiological parameters and the overall surgical experience. It may lead to increased heart rate, elevated blood pressure, respiratory distress, and psychological discomfort, increasing the risk of complications during and after surgery. Women facing gynecological cancer surgery often experience heightened anxiety due to concerns about survival, loss of reproductive organs, body image changes, and sexual health.\n\nVirtual reality (VR) has emerged as a promising non-pharmacological approach for reducing preoperative anxiety. By immersing patients in a calming virtual environment that engages visual and auditory senses, VR helps promote relaxation, reduce stress, and enhance the patient's sense of control before surgery. It is safe, easy to implement, cost-effective, and does not have the side effects associated with medications.\n\nAlthough VR has demonstrated effectiveness in reducing anxiety in various surgical contexts-including orthopedic, colorectal, and minor gynecological procedures-its impact in gynecologic oncology surgery remains underexplored. This randomized controlled trial aims to evaluate the effect of a VR intervention on preoperative anxiety, physiological parameters (blood pressure, heart rate, respiratory rate, oxygen saturation), and patient satisfaction in women scheduled for gynecologic oncology surgery.\n\nParticipants will be randomly assigned to either the intervention group (receiving VR) or the control group (receiving standard care). Anxiety and physiological measures will be evaluated before and after the respective intervention in both groups. Patient satisfaction will be assessed once, immediately after the intervention and before surgery.\n\nThe primary objective is to assess whether VR effectively reduces preoperative anxiety and stabilizes physiological indicators. The secondary objective is to evaluate patient satisfaction with the preoperative experience. This study will contribute to the evidence base for using VR as a nursing-led, non-invasive strategy to enhance surgical care in gynecologic oncology.",[76,77,78,79],"Preoperative Anxiety","Women's Health","Gynecological Cancers","Gynecological Surgery",[79,81,76,82,83],"Gynecological Oncology","Preoperative Anxiety Management","Virtual Reality","2025-09-09",{"date":86,"type":87},"2025-09-10","ACTUAL",{"date":89,"type":87},"2025-07-15",{"date":91,"type":70},"2026-07-15",{"name":5,"class":6},1]