[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599482":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":34,"responsibleParty":47,"collaborators":51,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":27,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":27,"enrollmentInfo":62,"targetDuration":27,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":74,"overallStatus":37,"whyStopped":27,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Sfax","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"internal control design","EXPERIMENTAL","The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session during the same procedure).",[13],"Device: VR session",{"label":15,"type":16,"description":17,"interventionNames":18},"external control group","ACTIVE_COMPARATOR","This arm consists of patients who will receive only standard care throughout the study. These external control participants will be matched to the interventional group based on age and procedure type, ensuring comparability between groups.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","VR session","Standard care: Standard care. In both the external control group and the intervention group during Period 1, painful procedures will be performed ccording to usual clinical practice by trained healthcare professionals.\n\nVR session: The device includes a VR headset connected to a smartphone, which displays immersive visual content, along with headphones that deliver audio content. Scenarios are culturally and demographically adapted to the study population. The duration of each VR session will correspond to the time required for each painful procedure.",[15,9],[26],"Standard care",null,[29],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Yesmine Amara, PhD student","CONTACT","00 216 50 260 564","benmahmoud_lobna@medecinesfax.org",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":27,"geoPoint":27,"contacts":43},"Clinical hematology department of unversity hospital of Hedi Chaker of Sfax, Tunisia","RECRUITING","Tunis","Sfax Governorate","3002","Tunisia","TN",[44],{"name":45,"role":31,"phone":32,"phoneExt":27,"email":46},"Yesmine Amara (principal investigator), PhD student","yesmine.amara8@gmail.com",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Yesmine Amara","Principal Investigator-PhD student",[52],{"name":5,"class":6},"100599482","distraction-with-virtual-reality-from-pain-and-anxiety-for-patients-with-hematological-malignancies-100599482",false,"NCT07085065","Distraction With Virtual Reality From Pain and Anxiety for Patients With Hematological Malignancies","Virtual Reality to Reduce Pain and Anxiety in Hematological Cancer Patients Undergoing Invasive Procedures: Protocol for a Crossover Clinical Trial","Inclusion Criteria\n\n* being ≥ 6 years old\n* having a confirmed diagnosis of a hematological malignancy\n* undergoing at least one of the following procedures: Bone Marrow Biopsy, Bone Marrow Aspiration, Lumbar Puncture, Venipuncture, or Chemotherapy.\n\nExclusion Criteria:\n\n* unstable or photosensitive epilepsy\n* hearing, visual, or inner ear impairments\n* severe psychiatric, cognitive, or mental disorders\n* Contagious diseases\n* Communication difficulties\n* Patients who withdraw consent\n* Patient who remove the VR headset during the procedure","ALL","6 Years",{"count":63,"type":64},365,"ESTIMATED","INTERVENTIONAL",[67],"NA","The goal of this clinical trial\\] is to study the effectiveness of Virtual Reality (VR) in reducing pain and anxiety during painful procedures for patients with hematological malignancies The main question\\[s\\] it aims to answer are:\n\nDoes VR effectively reduce pain during painful procedures for patients with hematological malignancies ? Does VR effectively reduce anxiety during painful procedures for patients with hematological malignancies ? Interventional group (intra-group comparaison): This design allows each patient to act as his own control.: The intervention consists of a complete sequence involving three phases: Period 1 (standard care), a washout period of at least seven days, and Period 2 (VR session).\n\nExternal control group (inter-group comparaison): Patients will be assigned to the intervention group first, and then a matching external control patient will be selected based on age and type of procedure.",[70,71,72,73],"Pain Management","Anxiety","Procedures","Hematological Neoplasms",[75,76,71,77,78,79],"Virtual Reality","Pain","Hematological Malignancies","Invasive procedures","Chemotherapy","2025-07-22",{"date":82,"type":83},"2025-07-25","ACTUAL",{"date":85,"type":83},"2024-02-01",{"date":87,"type":64},"2025-07-31",{"name":49,"class":6},1]