[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572777":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":53,"studyPopulation":53,"armGroups":60,"interventions":71,"overallOfficials":53,"centralContacts":77,"locations":83,"responsibleParty":108,"collaborators":111,"id":119,"slug":53,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":120,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":53,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":86,"whyStopped":53,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Centro Cardiologico Monzino","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":53},[9],{"measure":10,"description":11,"timeFrame":12},"Enteroceptive sensibility","Enteroceptive Sensibility (assessed with the Multidimensional Assessment of Interoceptive Awareness, version 2, MAIA-2)\n\nThe MAIA-2 is a 6-point Likert scale questionnaire with 37 items divided into 8 subscales. Higher scores reflect greater enteroceptive sensibility.","At 1 month after the end of the body scan intervention",[14,18,22,26,29,32,35,38,41,44,47,50],{"measure":15,"description":16,"timeFrame":17},"Enteroceptive Sensibility","Enteroceptive Sensibility (assessed with Multidimensional Assessment of Interoceptive Awareness, version 2, MAIA-2)\n\nMAIA-2 is a 6-point Likert scale questionnaire with 37 items divided into 8 subscales. Higher scores reflect greater interoception","At 3, 6, and 9 month after the end of the intervention",{"measure":19,"description":20,"timeFrame":21},"Enteroceptive Accuracy","Enteroceptive Accuracy (assessed with the Heartbeat Tracking Task)","At baseline, 1, 3, 6, and 9 months after the end of the intervention",{"measure":23,"description":24,"timeFrame":25},"Enteroceptive Awareness","Enteroceptive Awareness will be calculated with Pearson's r confidence, using the HTT score as a measure of interoceptive accuracy and a confidence VAS (0-10) as a partial measure of interoceptive sensibility","At baseline, after 1, 3, 6, and 9 months after the end of the intervention",{"measure":27,"description":28,"timeFrame":21},"Symptoms Perception","Symptom Perception (assessed with the Heart Failure Somatic Perception Scale), which is a 6-point Likert scale with 18 items. Higher scores reflect a higher impact of heart failure on patients' lives.",{"measure":30,"description":31,"timeFrame":21},"Generic Quality of Life","Quality of Life wil be assessed with the 5-dimensions version of EuroQoL (EQ-5D).\n\nThe EuroQoL is a standardized measure of health status divided into two sections: section one comprises 5 dimensions (Mobility, Self-Care, Usual Activities, Pain\u002FDiscomfort, Anxiety\u002FDepression) and 3 levels (no problems, some problems, extreme problems); section two asks participants to rank their perceived health status with a VAS ranging from 0 ('The worst health you can imagine') to 100 ('The best health you can imagine').",{"measure":33,"description":34,"timeFrame":21},"Heart Failure Specific Quality of Life","Heart Failure Specific Quality of Life will be measured using the 12-Items Kansas City Cardiomyopathy Questionnaire (KCCQ).\n\nThe KCCQ comprises 12 items exploring 4 dimensions. Scores range from 0 to 100, where 100 reflects a higher functioning level.",{"measure":36,"description":37,"timeFrame":21},"Self-care","Self-care will be assessed with the Self-Care of Heart Failure Index version 7.2.\n\nIt is a 29-item instrument exploring three dimensions with 5-point Likert-type options. Higher scores reflect better self-care",{"measure":39,"description":40,"timeFrame":21},"Self-care Self-efficacy","Self-care Self-efficacy will be assessed using the Self-Care Self-Efficacy Scale, which comprises 10 items, answerable from a 1 to 5 option-scale. Scores are standardized to range from 0 to 100, with higher scores representing higher levels of self-efficacy.",{"measure":42,"description":43,"timeFrame":21},"Anxiety","Anxiety (assessed with the State-Trait Anxiety Inventory Form Y, STAI-Y)\n\nThe State-Trait Anxiety Inventory Form Y (STAI-Y) is a validated questionnaire divided into two scales measuring state and trait anxiety, respectively. Both STAI-S and STAI-T comprise 20 items each, for a total of 40 items. Items are rated on a 4-point scale, with higher scores reflecting greater anxiety levels",{"measure":45,"description":46,"timeFrame":21},"Depression","Depression will be measured with the Beck Depression Inventory-II (BD-II).\n\nIt has 21 items, answerable on a 4-point Likert scale ranging from 0 to 3. Higher scores indicate greater severity of depression symptoms",{"measure":48,"description":49,"timeFrame":21},"Alexithymia","Alexithymia will be assessed using the 20-item Toronto Alexithymia Scale (TAS-20). It comprises 3 factors, answerable with a 5-point Likert scale, with increasing scores indicating higher degrees of alexithymia.",{"measure":51,"description":52,"timeFrame":21},"Emotional Regulation","Emotional Regulation will be assessed with the Emotional Regulation Questionnaire (ERQ).\n\nERQ is a 10-item self-report questionnaire, rated on a 7-point Likert scale from 1 ('Strongly Disagree') to 7 ('Strongly Agree'), with higher scores indicating higher emotional regulation",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"Experimental group","EXPERIMENTAL","The experimental group will receive a body scan intervention. Body scan is a guided meditation technique that allows people to detect signs and signals from their body (for instance, heart rate).\n\nThe intervention will last 20 minutes and will be performed 21 consecutives days. The first and last days it will be performed in presence, while the other ones online.",[66],"Behavioral: Body Scan",{"label":68,"type":69,"description":70,"interventionNames":53},"Control group","NO_INTERVENTION","The control group will not receive the intervention, but only standard care",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":53},"BEHAVIORAL","Body Scan","Body scan is a guided meditation technique that allows people to detect signs and signals from their body (for instance, heart rate).\n\nThe intervention will last 20 minutes and will be performed 21 consecutives days. The first and last days it will be performed in presence, while the other ones online.",[62],[78],{"name":79,"role":80,"phone":81,"phoneExt":53,"email":82},"Alessia M Trenta, Dr","CONTACT","00390258002445","alessia.trenta@cardiologicomonzino.it",[84,102],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":88,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":97},"Cardiology Center Monzino IRCCS","RECRUITING","Milan","Italy","20138","IT",{"type":92,"coordinates":93},"Point",[94,95],9.18951,45.46427,{"lat":95,"lon":94},[98,100],{"name":99,"role":80,"phone":81,"phoneExt":53,"email":82},"Alessia Martina Trenta, Dr",{"name":99,"role":101,"phone":53,"phoneExt":53,"email":53},"PRINCIPAL_INVESTIGATOR",{"facility":103,"status":104,"city":87,"state":53,"zip":89,"country":88,"countryCode":90,"cosmosGeoPoint":105,"geoPoint":107,"contacts":53},"IRCCS Cardiology Center Monzino","NOT_YET_RECRUITING",{"type":92,"coordinates":106},[94,95],{"lat":95,"lon":94},{"type":101,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Alessia Trenta","Dr",[112,114,117],{"name":113,"class":6},"University of Rome Tor Vergata",{"name":115,"class":116},"Bicocca Universiy of Milano, Milan, Italy","UNKNOWN",{"name":118,"class":116},"American Holistic Nurses Association (AHNA)","100572777",false,"NCT06737679","The Effects of Body Scan on Enteroception in Patients With Heart Failure","The Effects of Body Scan on Enteroception in Patients With Heart Failure: a Randomized Controlled Trial","SCAN-HF","Inclusion Criteria:\n\n* Diagnosed with Heart Failure\n* Italian speaking\n* Willing to sign the Informed Consent Form\n\nExclusion Criteria:\n\n* Cognitive Impairment documented in the medical records","ALL","18 Years","75 Years",{"count":130,"type":131},110,"ESTIMATED","INTERVENTIONAL",[134],"NA","The study aims to explore the effects of body scan on enteroception in people with heart failure",[137],"Heart Failure",[139,140,141,142,143],"Heart failure","Enteroception","Body scan","Mindfullness","Self-care monitoring","2025-02-05",{"date":146,"type":147},"2025-02-07","ACTUAL",{"date":149,"type":147},"2025-01-28",{"date":151,"type":131},"2026-01-31",{"name":5,"class":6},2]