[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657842":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":44,"interventions":55,"overallOfficials":34,"centralContacts":34,"locations":63,"responsibleParty":73,"collaborators":34,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":34,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":34,"enrollmentInfo":86,"targetDuration":34,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":105,"whyStopped":34,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Dokuz Eylul University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"postoperative pain","Pain intensity will be measured using a Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain) immediately after the procedure. Measurements will be taken three times: on the second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.","The second day after surgery, immediately before the procedure, immediately after the procedure, and 30 minutes later.",[14,18,21,25,28,31],{"measure":15,"description":16,"timeFrame":17},"Preoperative and postoperative anxiety levels","Anxiety levels will be assessed using the State Anxiety Inventory-Short Form (STAIS-S). The scale measures temporary anxiety levels. Scores range from 20 to 80. Measurements will be taken four times: one day before surgery; on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate higher (worse) anxiety.","One day before surgery; the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.",{"measure":19,"description":20,"timeFrame":17},"Pre- and post-surgery satisfaction levels","Patient satisfaction will be assessed using a Visual Analog Scale (VAS) ranging from 0 (not at all satisfied) to 10 (extremely satisfied). Measurements will be taken four times: one day before surgery; on the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure. Higher scores indicate greater satisfaction.",{"measure":22,"description":23,"timeFrame":24},"Systolic Blood Pressure","Systolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher systolic blood pressure.","On the second day after surgery; immediately before the procedure; immediately after the procedure; and 30 minutes after the procedure.",{"measure":26,"description":27,"timeFrame":24},"Diastolic Blood Pressure","Diastolic blood pressure will be measured in millimeters of mercury (mmHg). Higher values indicate higher diastolic blood pressure.",{"measure":29,"description":30,"timeFrame":24},"Pulse Rate","Pulse rate will be measured in beats per minute (beats\u002Fmin).",{"measure":32,"description":33,"timeFrame":24},"Respiratory Rate","Respiratory rate will be measured in breaths per minute (breaths\u002Fmin).",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":40,"maskingDescription":41,"whoMasked":42},"SINGLE","Statistical analysis of the data will be conducted by an independent researcher who is blinded to the group information regarding the intervention and control groups. To maintain the researcher's blindness, the groups will be coded during the analysis process, and the researcher will not be informed of which group each code corresponds to until the analysis is complete.",[43],"OUTCOMES_ASSESSOR",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Virtual Reality Group","EXPERIMENTAL","For patients admitted to the ward for surgery, the researcher will have them complete the State Anxiety Scale and the Satisfaction Scale one day before surgery. On the second postoperative day in the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form.",[50],"Behavioral: Virtual Reality Glasses",{"label":52,"type":53,"description":54,"interventionNames":34},"Control Group","NO_INTERVENTION","Patients admitted to the ward for surgery will complete the State Anxiety Scale and the Satisfaction Scale administered by the researcher one day before surgery. Patients will be admitted to the clinic on the second postoperative day, and their care will continue to be provided by the nurse responsible for their care as part of routine clinical practice. The researcher will not perform any additional interventions. At the same time as the group receiving the virtual reality headset intervention, the researcher will again have patients complete the Numerical Pain Scale, State Anxiety Scale, Numerical Satisfaction Scale, and Physiological Parameters Monitoring Form.\n\n(Measurements will be taken during the preoperative period; however, patients who do not meet the inclusion criteria postoperatively will not be included in the study.)",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"BEHAVIORAL","Virtual Reality Glasses","One day before surgery, the researcher will have participants in this group complete the State Anxiety Scale and the Satisfaction Scale. On the second postoperative day at the clinic, the researcher will fit patients with virtual reality goggles, and the patient will watch nature-themed videos-such as forest scenes, beach walks, and parks-for 10 minutes. After 10 minutes, the virtual reality session will end. Immediately after the intervention and 30 minutes later, the same researcher will have the patients complete the Numerical Pain Scale, the State Anxiety Scale, the Numerical Satisfaction Scale, and the Physiological Parameters Monitoring Form. This distraction technique aims to reduce pain perception and anxiety levels, increase patient satisfaction during the procedure, and improve physiological parameters.",[46],[62],"VR Glasses",[64],{"facility":5,"status":34,"city":65,"state":34,"zip":34,"country":66,"countryCode":34,"cosmosGeoPoint":67,"geoPoint":72,"contacts":34},"Izmir","Turkey (Türkiye)",{"type":68,"coordinates":69},"Point",[70,71],27.13838,38.41273,{"lat":71,"lon":70},{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Gizem Göktuna","Assistant Professor","100657842","the-effect-of-virtual-reality-headsets-on-pain-anxiety-patient-satisfaction-and-physiological-parameters-in-patients-undergoing-open-heart-surgery-100657842",false,"NCT07843511","The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery","The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 18 and older\n* Who have not previously undergone open-heart surgery\n* Non-emergency, elective surgeries\n* Who have not taken pain medication 4-6 hours prior to the procedure\n* Who have a numerical pain scale score of 3 or higher prior to the procedure\n* Patients with sufficient cognitive ability to tolerate the virtual reality headset application\n* Patients who voluntarily agree to participate in the study\n* Patients extubated on the second postoperative day\n* Patients with no history of chronic pain (e.g., arthritis)\n* Being alert and oriented enough to communicate (Glasgow Coma Scale 15)\n* Not being addicted to alcohol or drugs\n* Not using anxiolytics\n* Having no psychological problems (such as depression or anxiety disorders)\n* Being able to read and understand Turkish\n\nExclusion Criteria:\n\n* • Under 18 years of age\n\n  * With vision or hearing loss\n  * Clinically unstable\n  * With a known history of epilepsy, vertigo, or limited mobility\n  * With a surgical incision or scar on the face that prevents wearing VR goggles\n  * Chronic opioid use or use of psychiatric medications","ALL","18 Years",{"count":87,"type":88},44,"ESTIMATED","INTERVENTIONAL",[91],"NA","This randomized controlled trial aims to investigate the effects of virtual reality headset use on pain, anxiety, patient satisfaction, and physiological parameters in patients undergoing open-heart surgery. Participants will be randomly assigned to two groups: the virtual reality group and the control group. Pain levels, anxiety levels, satisfaction levels, and physiological parameters will be assessed both before and after the procedure. The study aims to determine whether this non-pharmacological method improves postoperative pain, anxiety, patient satisfaction, and physiological parameters.",[94,95,96,97,98],"Pain After Surgery","Pain and Anxiety","Anxiety After Surgery","Anxiety","Open Heart Surgery",[100,98,101,102,97,103,104],"Virtual Reality","Physiological Parameters","Pain","Patient Satisfaction","Non-pharmacological Intervention","NOT_YET_RECRUITING","2026-09-25",{"date":108,"type":109},"2026-09-28","ACTUAL",{"date":111,"type":88},"2026-09-23",{"date":113,"type":88},"2027-03",{"name":5,"class":6},1]