[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549445":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":23,"responsibleParty":30,"collaborators":23,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":23,"enrollmentInfo":42,"targetDuration":23,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":56,"whyStopped":23,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":64,"locationsCount":23},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immersive virtual reality in patient with VAS dyspnea ≥ 3","EXPERIMENTAL","Once included in the study, the patient will undergo a 15-minute session of mechanical ventilation followed by a 15-minute weaning trial without intervention (control period).\n\nA respiratory discomfort VAS is performed following the spontaneous breathing trial. If the VAS is ≥ 3 cm, the patient is randomised between the intervention group (immersive virtual reality) and the control group (standard care).\n\nThe spontaneous breathing trial will be continued for a further 15 minutes in accordance with usual management, with one of the two interventions according to randomisation.",[13],"Device: Immersive virtual reality",{"label":15,"type":10,"description":11,"interventionNames":16},"Control in patient with VAS dyspnea ≥ 3",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Immersive virtual reality","The virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support.\n\nVirtual reality will be achieved using a virtual reality headset (GAMIDA®, Pico G2 4K, France) and audio headphones with noise reduction (Bose® Quiet Comfort 35 II, France). A tablet (Samsung® Galaxy Tab A 2019, 4G \u002F Lenovo M8, France) equipped with Healthy Mind software will enable patients to enjoy a 360° visual and auditory 3D experience via a Bluetooth connection.",[15,9],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Capucine MORELOT-PANZINI, MD,PHD","CONTACT","+33 1 42 16 78 59","capucine.morelot@aphp.fr",{"type":31,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100549445","benefits-of-immersive-virtual-reality-on-dyspnoea-during-a-weaning-test-in-the-intensive-care-unit-100549445",false,"NCT06434116","Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit.","Benefits of Immersive Virtual Reality on Dyspnoea During a Weaning Test in the Intensive Care Unit","RVI-ERS","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients intubated and on mechanical ventilation for more than 24 hours\n3. Patients eligible for a weaning trial (resolution of acute phase of pathology, low bronchial congestion, effective cough, SpO2 \\> 90% with Fio2 \\\u003C 40%, PEEP \\\u003C 8 cmH20, respiratory rate \\\u003C 40\u002Fmin, haemodynamically stable)\n4. Decision by the doctor in charge to initiate a respiratory weaning trial as part of treatment\n5. RASS score between -1 and +1\n6. Patient able to answer questionnaires\n7. Informed of the study and whose free and informed written consent has been obtained\n8. Beneficiary of a social security plan (excluding AME)\n\nExclusion Criteria:\n\n1. Non french speaker\n2. Acute confusion or cognitive disorders\n3. No reliable assessment of dyspnea\n4. Acrophobia\n5. Claustrophobia\n6. Photophobia\n7. Hearing loss\n8. Visual impairment\n9. Subject under guardianship or curatorship","ALL","18 Years",{"count":43,"type":44},30,"ESTIMATED","INTERVENTIONAL",[47],"NA","A weaning trial is a test that simulates physiological respiratory conditions after extubation in order to assess the patient's ability to breathe without the assistance of a ventilator.\n\nThis test is highly susceptible to induce dyspnea, with 62% of patients reporting a dyspnea score on VAS greater than 3.\n\nSimilarly, the prevalence of anxiety is high during weaning trials. 60% of patients treated in a respiratory weaning unit report psychological symptoms.\n\nDyspnea can be a traumatic experience for patients. In intensive care, up to half of patients suffer from dyspnea, which is described by patients as one of the worst memories of their stay in intensive care.\n\nThe virtual reality headset is a device that simulates a realistic, three-dimensional environment, allowing the patient to be totally immersed, so that they feel as if they are really present in a virtual world. This environment can be combined with hypnotic verbal support.\n\nThe research hypothesis is that virtual reality during a spontaneous breathing trial would relieve the respiratory discomfort induced by the weaning trial.\n\nThe secondary hypotheses are that virtual reality could reduce the anxiety associated with spontaneous breathing trials. These benefits could be associated to a reduction in ventilatory drive.\n\nTo assess dyspnea a VAS scale will be used, as the MV-RDOS scale, and the amplitude of EMG activity of inspiratory muscles.",[50],"Spontaneous Breathing Trial in ICU",[52,53,54,55],"Spontaneous breathing trial","dyspnea","virtual reality","anxiety","NOT_YET_RECRUITING","2025-06-30",{"date":59,"type":60},"2025-07-03","ACTUAL",{"date":62,"type":44},"2025-10-03",{"date":62,"type":44},{"name":5,"class":6}]