[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597101":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":42,"responsibleParty":168,"collaborators":24,"id":170,"slug":171,"hasResults":172,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":172,"sex":177,"minAge":178,"maxAge":24,"enrollmentInfo":179,"targetDuration":24,"studyType":182,"phases":183,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":193,"whyStopped":24,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Patients receive an MBSR (Mindfulness on Stress Reduction) meditation program delivered by a certified instructor.",[13],"Other: Mindfulness-Based Stress Reduction (MBSR) meditation program",{"label":15,"type":6,"description":16,"interventionNames":17},"Control group","Patients will be in a wait list group. They will receive their usual care during the study follow-up. Between M8 and M10 they will receive a MBSR meditation program",[18],"Other: Control group",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Mindfulness-Based Stress Reduction (MBSR) meditation program","The sessions of the meditation program (Mindfulness on Stress Reduction) will be delivered online, outside of the dialysis sessions. They will receive standard care during their hemodialysis sessions.\n\nThe program is composed of 8 sessions of 2h30 + 1 day of mindfulness, during 2 months.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Patients in the control group will be in a wait list group. They will receive standard care during their hemodialysis sessions. they will receive the MBSR meditation program between M8 and M10.",[15],[29],{"name":30,"affiliation":31,"role":32},"Marine NAUDIN, PhD","CHRU de Tours","PRINCIPAL_INVESTIGATOR",[34,38],{"name":30,"role":35,"phone":36,"phoneExt":24,"email":37},"CONTACT","+33 2.47.47.91.23","m.naudin@chu-tours.fr",{"name":39,"role":35,"phone":40,"phoneExt":24,"email":41},"Bénédicte Sautenet, PU-PH","+33 2 47 47 02 80","benedicte.sautenet@univ-tours.fr",[43,58,70,82,94,106,118,130,142,156],{"facility":44,"status":24,"city":45,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"CH Angers","Angers","France","FR",{"type":49,"coordinates":50},"Point",[51,52],-0.55202,47.47156,{"lat":52,"lon":51},[55],{"name":56,"role":35,"phone":24,"phoneExt":24,"email":57},"Virginie BESSON","vibesson@chu-angers.fr",{"facility":59,"status":24,"city":60,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"CH Bayonne","Bayonne",{"type":49,"coordinates":62},[63,64],-1.473,43.49316,{"lat":64,"lon":63},[67],{"name":68,"role":35,"phone":24,"phoneExt":24,"email":69},"Pauline D'HALLUIN","pdhalluin@ch-cotebasque.fr",{"facility":71,"status":24,"city":72,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"CHRU de Bordeaux","Bordeaux",{"type":49,"coordinates":74},[75,76],-0.58046,44.84124,{"lat":76,"lon":75},[79],{"name":80,"role":35,"phone":24,"phoneExt":24,"email":81},"Thomas BACHELET","thomas.bachelet@mailo.com",{"facility":83,"status":24,"city":84,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"AIRBP 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QUERARD","anne-helene.querard@ght85.fr",{"facility":119,"status":24,"city":120,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"ECHO Nantes","Nantes",{"type":49,"coordinates":122},[123,124],-1.55336,47.21725,{"lat":124,"lon":123},[127],{"name":128,"role":35,"phone":24,"phoneExt":24,"email":129},"Lila GHOUTI","lghouti@echo-sante.com",{"facility":131,"status":24,"city":132,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"ATTIRO Orléans","Orléans",{"type":49,"coordinates":134},[135,136],1.90407,47.90248,{"lat":136,"lon":135},[139],{"name":140,"role":35,"phone":24,"phoneExt":24,"email":141},"Alexandru GANEA","alexandru.ganea@chr-orleans.fr",{"facility":143,"status":24,"city":144,"state":24,"zip":145,"country":46,"countryCode":47,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"CHRU De Tours","Tours","37000",{"type":49,"coordinates":147},[148,149],0.70398,47.39484,{"lat":149,"lon":148},[152],{"name":153,"role":35,"phone":154,"phoneExt":24,"email":155},"Nicolas GOIN","(+33) 2 47 47 37 39","nicolas.goin@chu-tours.fr",{"facility":157,"status":24,"city":158,"state":24,"zip":24,"country":46,"countryCode":47,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"CALYDIAL","Vienne",{"type":49,"coordinates":160},[161,162],4.87484,45.52569,{"lat":162,"lon":161},[165],{"name":166,"role":35,"phone":24,"phoneExt":24,"email":167},"Abdallah GUERRAOUI","Abdallah.guerraoui@calydial.org",{"type":169,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100597101","efficacy-of-live-online-course-mindfulness-program-on-perceived-fatigue-in-hemodialysis-patients-100597101",false,"NCT07054112","Efficacy of Live Online Course Mindfulness Program on Perceived Fatigue in Hemodialysis Patients","MEDIA","Inclusion Criteria:\n\n* Age \\>= 18 years old\n* Written informed consent obtained from the participant\n* Patients on chronic hemodialysis for more than 3 months\n* Participant affiliated to social security system\n* Internet access\n* Patient motivation\u002Fcommitment\n* Patient having 3 days of dialysis per week\n\nExclusion Criteria:\n\n* Major acute depression\n* Patient on peritoneal dialysis\n* Already participated in an MBSR program\n* Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code (corresponding to protected persons: pregnant women, women who have recently given birth or are breastfeeding, persons deprived of their rights by judicial or administrative decision, minors, and persons benefiting from legal protection: curatorship or guardianship).\n* Planned hospitalization within 4 months\n* Known cognitive disorder (Mini Mental State Evaluation \\\u003C23 for more than 65 years)\n* Known schizophrenia\n* Known psychotic personality disorder\n* Suicide attempt or suicidal ideation\n* Addiction to alcohol or drugs during addiction treatment\n* Cancer undergoing chemotherapy\n* Pathological grieving process\n* Compulsive eating disorders\n* No understanding of French\n* Unaided deafness","ALL","18 Years",{"count":180,"type":181},80,"ESTIMATED","INTERVENTIONAL",[184],"NA","The goal of this clinical trial is to assess the efficacy of a 2-month live online mindfulness meditation program in reducing perceived fatigue (measured by the SONG-HD Fatigue Scale) in patients undergoing chronic hemodialysis.\n\nThe sponsor expects that a live online mindfulness meditation course will have a significant public health impact by reducing perceived fatigue, which is strongly associated with cardiovascular events, mortality, and reduced quality of life.\n\nParticipants will be enrolled according to eligibility criteria and randomized into one of the following groups:\n\nExperimental group: will receive an 8-week live online Mindfulness-Based Stress Reduction (MBSR) program.\n\nControl group: will receive standard care during their hemodialysis sessions and will be offered the same live online MBSR program between months 8 and 10.\n\nPatients will complete self-administered questionnaires at baseline, 2 months, 8 months, and 10 months to monitor changes in fatigue, anxiety, and quality of life.",[187],"Chronic Kidney Disease Requiring Hemodialysis",[189,190,191,192],"chronic kidney desease","MBSR program","fatigue","Song scale","NOT_YET_RECRUITING","2025-07-02",{"date":196,"type":197},"2025-07-08","ACTUAL",{"date":199,"type":181},"2025-09-30",{"date":201,"type":181},"2027-07-30",{"name":5,"class":6},10]