[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647729":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":28,"locations":39,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":17,"enrollmentInfo":73,"targetDuration":17,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":42,"whyStopped":17,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Turin, Italy","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group","EXPERIMENTAL","Assignment to the experimental and control groups will be performed using block randomization with variable block lengths.\n\nThe stratification criteria are as follows:\n\n* Gender: Male (M) vs. Female (F)\n* Type of intervention: with vs. without simultaneous reconstruction with flaps.\n\nThe intervention consists of two clinical-psychological interviews with a psychoanalytic framework, each lasting 60 minutes, integrating biofeedback techniques. Interviews will be recorded and transcribed verbatim.",[13],"Other: Brief clinical psychological intervention using biofeedback techniques",{"label":15,"type":16,"description":17,"interventionNames":17},"Control Group","NO_INTERVENTION",null,[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":17},"Brief clinical psychological intervention using biofeedback techniques","Intervention type: Clinical psychological intervention using biofeedback tecniques.\n\nThe intervention consists of two 60-minute clinical psychological sessions with a psychoanalytic framework. A biofeedback device with physiological sensors is used during the sessions to monitor physiological responses and provide real-time feedback during patients' diaphragmatic breathing. The biofeedback device does not constitute a separate intervention.\n\nDuring the first session, the clinician explores the patient's illness history, emotions, relationships, and experience of diagnosis and surgery. A biofeedback baseline is recorded, followed by diaphragmatic breathing training to support emotional regulation. In the second session, the clinician discusses the patient's experience after training, changes in emotions, and expectations about surgery and recovery. Biofeedback and breathing exercises are repeated.",[9],[24],{"name":25,"affiliation":26,"role":27},"Monica Agnesone, Director, Psychology Unit","ASL Città di Torino","PRINCIPAL_INVESTIGATOR",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Antonella Granieri, Full Professor","CONTACT","3204361389","+39","antonella.granieri@unito.it",{"name":36,"role":31,"phone":37,"phoneExt":33,"email":38},"Maria Domenica Sauta, PhD Student","3402816558","mariadomenica.sauta@unito.it",[40],{"facility":41,"status":42,"city":43,"state":17,"zip":17,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Head and Neck Cancer Unit, Asl Città di Torino","RECRUITING","Turin","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],7.68682,45.07049,{"lat":50,"lon":49},[53],{"name":54,"role":31,"phone":55,"phoneExt":17,"email":56},"Giovanni Succo Full Professor","0115661566","giovanni.succo@unito.it",{"type":58,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[60],{"name":61,"class":62},"ASL Città di Torino, Italy","UNKNOWN","100647729","brief-clinical-psychological-intervention-with-biofeedback-in-head-and-neck-cancer-100647729",false,"NCT07712120","Brief Clinical Psychological Intervention With Biofeedback in Head and Neck Cancer","Integrating Clinical Psychology Into the Care of Patients With Head and Neck Cancer: A Pilot Randomized Controlled Trial","INTEGRATE-HNC","Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n* Patients with a diagnosis of head and neck cancer scheduled to undergo demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction.\n* Age ≥18 years at the time of signing the informed consent form.\n* Ability to understand and communicate in Italian.\n\nExclusion Criteria\n\nParticipants will be excluded if they:\n\n* Are unable to provide written informed consent.\n* Have a diagnosed psychiatric disorder.\n* Have a diagnosed neurocognitive impairment.\n* Are currently undergoing psychological or psychotherapeutic treatment.","ALL","18 Years",{"count":74,"type":75},58,"ESTIMATED","INTERVENTIONAL",[78],"NA","Head and neck cancer and its surgical treatment may significantly affect patients' psychological well-being, body image, somatic experience, and quality of life. This pilot randomized controlled non-pharmacological study aims to evaluate the short-term efficacy of a brief clinical psychological intervention including biofeedback techniques in reducing post-traumatic stress symptoms in patients undergoing demolitive surgery of the oral cavity or oropharynx, with or without simultaneous flap reconstruction.\n\nSecondary objectives are to evaluate the effects of the intervention on somatopsychic distress and quality of life, assess the persistence of intervention effects over time, and examine the impact of flap reconstruction on patients' psychological outcomes and quality of life.\n\nEligible participants will be randomly assigned to either an experimental group receiving two 60-minute clinical psychological sessions integrating biofeedback techniques or a control group receiving standard care without the study intervention. Psychological and clinical assessments will be performed at baseline (before surgery), at hospital admission for surgery, and at the post-discharge follow-up visit.",[81,82,83],"Head and Neck Cancer","Surgery for Head and Neck Cancer Patients","Demolitive Surgical Procedures on the Oral Cavity or Oropharynx, With or Without Simultaneous Reconstruction Using Flaps",[85,86,87,88,89,90,91,92,93,94],"Quality of life","RCT","Head and neck cancer","post-traumatic stress symptoms","body image","biofeedback","clnical psychology","Mentalization","Personality traits","Psychotherapy","2026-07-15",{"date":97,"type":98},"2026-07-17","ACTUAL",{"date":100,"type":98},"2025-11-20",{"date":102,"type":75},"2027-11",{"name":5,"class":6},1]