[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589998":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":25,"collaborators":29,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":39,"eligibilityCriteria":40,"healthyVolunteers":35,"sex":41,"minAge":42,"maxAge":18,"enrollmentInfo":43,"targetDuration":18,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":59,"whyStopped":18,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":18},{"fullName":5,"class":6},"Babes-Bolyai University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VR Mindfulness Intervention Group","EXPERIMENTAL","Participants in this arm will undergo a structured protocol including a VR-based mindfulness intervention. Patients are guided through psychoeducation about mindfulness, and the VR procedure. Patients are invited to express their worries about the intervention or the surgery, which are normalized and addressed through reflective listening. The mindfulness session in VR lasts approximately 10 minutes and is supervised by the clinical psychologist.\n\nA structured debriefing follows the VR session, using the 4Fs model:\n\nFeelings: How did the patient feel during the session? Findings: Did they discover anything helpful or meaningful? Futures: How can they apply mindfulness during hospitalization or at home? Follow-up: They receive a home practice suggestion (4x4 breathing technique) connected to a meaningful thought, image, or feeling from the VR session.\n\nAssesments at four time points.",[13],"Behavioral: VR Mindfulness-Based Relaxation",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as Usual (TAU) Group","NO_INTERVENTION","Participants in this group will receive the standard preoperative and postoperative care provided by the hospital, without any additional intervention from the research team.\n\nAssesments at 3 time points.\n\n1. Before the intervention (Day 1)\n2. After surgery (Day 2)\n3. Two weeks after surgery (follow-up)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","VR Mindfulness-Based Relaxation","VR Mindfulness-Based Relaxation is a behavioral intervention that utilizes a VR application designed to reduce anxiety and promote relaxation. Participants in the experimental group will undergo a single VR session, scheduled on the day of hospital admission (one day prior to surgery).\n\nThe session lasts approximately 10 minutes and features an immersive beach environment combined with an audio-guided mindfulness exercise focused on breath awareness. Following the session, participants will engage in a brief, structured debriefing, during which they will reflect on what they felt, what they discovered, and how they can apply these insights during their hospital stay.\n\nParticipants will also be instructed to practice the 4-1-4 breathing technique three times per day during hospitalization. This technique involves inhaling for 4 seconds, holding the breath for 1 second, and exhaling for 4 seconds. It is intended to promote relaxation and support autonomic nervous system regulation.",[9],{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Roxana Cardos","Principal Investigator",[30],{"name":31,"class":32},"Cluj-Napoca County Emergency Clinical Hospital, Surgery Department 2","UNKNOWN","100589998","the-efficacy-of-a-mindfulness-based-virtual-reality-intervention-to-reduce-pain-in-postoperative-patients-100589998",false,"NCT06961695","The Efficacy of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients","Assessing the Effectiveness of a Mindfulness-Based Virtual Reality Intervention to Reduce Pain in Postoperative Patients: A Controlled Clinical Study","VR-MindPain","Inclusion Criteria\n\n* The participant is scheduled for surgery and is currently hospitalized for hernia or varicose vein procedures.\n* The participant is on the hospital's surgical waiting list.\n* The participant is willing and able to provide informed consent.\n* The participant agrees to participate in the study and to complete all required assessments during hospitalization and at follow-up (either at home or during post-operative medical visits).\n\nExclusion Criteria\n\n* Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); mild cognitive impairment does not constitute an exclusion criterion.\n* Limited proficiency in the Romanian language.\n* Active substance use or alcohol use disorders that, in the opinion of the investigators, may interfere with participation.\n* History of motion sickness.\n* Severe visual impairment (e.g., inability to see clearly without glasses); patients who use contact lenses are not excluded.\n* Use of strong opioids (e.g., morphine).\n* Current suicide risk.","ALL","18 Years",{"count":44,"type":45},64,"ESTIMATED","INTERVENTIONAL",[48],"NA","The goal of this randomized clinical trial is to evaluate whether a virtual reality (VR) mindfulness intervention can reduce anxiety and postoperative pain in adults undergoing surgery, primarily hernia and varicose vein procedures.\n\nThe main research questions are:\n\n* Does a preoperative VR mindfulness intervention reduce anxiety before surgery?\n* Does this reduction in anxiety result in lower postoperative pain compared to usual care?\n* Does the intervention help prevent chronic pain two weeks after surgery? Researchers will compare a VR mindfulness intervention group with a treatment-as-usual (TAU) group to assess the intervention's effectiveness.\n\nParticipants will:\n\n* Be randomly assigned to one of two groups:\n\n  * Experimental group: Receive a VR mindfulness session on the first day of hospitalization (one day before surgery).\n  * Control group: Receive standard hospital care (no intervention).\n* Complete psychological and pain assessments at four time points:\n\n  1. Before the intervention (Day 1)\n  2. Immediately after the intervention (only the experimental group, Day 1)\n  3. After surgery (Day 2)\n  4. Two weeks after surgery (follow-up)\n* Report pain intensity using the Numeric Rating Scale (NRS) at four postoperative time points.\n\nBefore enrollment, participants will undergo a structured interview to assess eligibility.\n\nThis study aims to determine whether reducing preoperative anxiety through VR mindfulness contributes to improved pain management and a lower risk of developing chronic pain following surgery.",[51,52],"Pain, Postoperative","Anxiety Preoperative",[54,55,56,57,58],"Postoperative Pain","Mindfulness-Based Intervention","Pain Management","Chronic Pain Prevention","Virtual Reality","NOT_YET_RECRUITING","2025-05-06",{"date":62,"type":63},"2025-05-08","ACTUAL",{"date":65,"type":45},"2025-05-12",{"date":67,"type":45},"2025-07-05",{"name":5,"class":6}]