[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychological-safety\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychological-safety":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100623441","operating-room-black-box-supported-debriefings-and-their-effect-on-healthcare-professionals-effectiveness-and-psychological-safety-100623441",false,"NCT07396675","Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Effectiveness and Psychological Safety.","Improving Postoperative Debriefings: the Added Value of Operating Room Black Box Supported Debriefings and Their Effect on Healthcare Professionals Perceived Effectiveness and Psychological Safety.","ORBLACKBOX","Inclusion Criteria:\n\n* Participants work in an OR-team at RIGS, AUMC or UKE.\n* Participants must have given informed written consent to participate in the study.\n* Participants must be in the OR for the majority of the procedure or\u002Fand have a central role in the teamwork.\n* At RIGS and AUMC participants for the ORBB debriefings must also be part of teams conducting surgeries in the OR where ORBB is installed (not all ORs have ORBB).\n* Participants can either be surgeons, anesthesiologist, anesthesia nurses, residents, OR-nurses, perfusionists, interns, nurse students or other OR-staff.\n\nExclusion Criteria:\n\n* Visitors, guests, and other staff only watching the surgery, are excluded from participation.\n* Individuals who are unable or unwilling to provide written informed consent.","ALL","18 Years",{"count":20,"type":21},135,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is enrolled in the European KEEPCARING Project. KEEPCARING aims to (re-)build wellbeing and resilience of healthcare workforce in EU hospitals by co-creating a multi-faceted non-digital, digital, and AI-supported solution package to prevent burnout among (aspirant) healthcare professionals on the individual, team, and organizational level.\n\nThis study specifically investigate the operating room staff wellbeing and resilience. The healthcare system is currently struggling to retain and attract operating room personnel. A factor of importance to consider here is occupational stress. If not recognized or mitigated well, occupational stress and personal efficacy can eventually evolve into a syndrome labelled as 'burnout'. In addition, communication and resilience patterns between operating room staff members are of influence, poor and\u002For inadequate communication among staff may be a factor of stress, compromising their work and wellbeing. In contrast, communication patterns that have a high standard and clarity may support resilience. The ability to speak up and being able to advocate concerns of all team members is of the highest importance here. Indeed, psychological safety and effective teamwork patterns are key for the working environment, performance, patient safety, and job satisfaction. To prevent mistakes during surgery, a safe space where team members can freely speak up is vital.\n\nTo improve psychological safety, and teamwork among OR staff, team debriefing after surgery is known to be effective. What is not known; is whether team debriefing with the additional support derived from audio- and video recordings of the surgery is equally effective as debriefing without.\n\nThe objective of this study is to evaluate the impact of structured postoperative debriefings with and without procedural, structured audio- and video recordings, on team performance, psychological safety, and non-technical skills in the operating room. Specifically, this study aims to compare augmented debriefings with non-augmented debriefings, to assess differences in perceived usefulness, psychological safety, and observed improvements in teams' non-technical skills.\n\nThis is an international quasi-experimental comparative study. The intervention consists of postoperative team debriefing using audio and video recordings ('augmented debriefing') from Operating Room Black Box system provided by Surgical Safety Technologies. The control group will have a postoperative team debriefing that is not augmented with Operating Room Black Box derived data. An identical debriefing template will be designed for both groups.",[27,28,29,30,31],"Stress","Resilience","Psychological Safety","Burnout, Healthcare Workers","Teamwork",[33,34,35,36,37],"debriefing","teamwork","psychological safety","operating room","operating room black box","RECRUITING","2026-04-15",{"date":41,"type":42},"2026-04-20","ACTUAL",{"date":44,"type":42},"2026-03-01",{"date":46,"type":21},"2027-10-01",{"name":48,"class":49},"ORNND - Operating Room Nurse Network Denmark","NETWORK",3,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100558335","body-oriented-psychotherapy-for-individuals-with-a-history-of-child-maltreatment-and-trauma-related-symptoms-100558335","NCT06549777","Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms","Body-oriented Psychotherapy vs. Psychoeducation and Treatment Information for Individuals With a History of Child Maltreatment and Trauma-related Symptoms: Assessing Safety, Feasibility, Acceptability, and Preliminary Outcomes","Inclusion Criteria:\n\n* Adults (18 years or older).\n* Proficiency in Swedish Language.\n* Access to a computer\u002Finternet.\n* Meeting CTQ-cutoff for CM history (CTQ rating higher than 'none \u002F minimal' in at least one of the subscales according to Bernstein and Fink (1998) (i.e. ≥10 for emotional neglect, ≥ 8 for physical neglect, ≥9 for emotional abuse, ≥8 for physical abuse and ≥6 for sexual abuse).\n* Meeting at least moderate\u002Fsevere PTSD or complex PTSD symptoms on the ITQ.\n* If taking medication, it must have been ongoing for at least 3 months and the dose must have been stable for 1 month.\n* Signed informed consent provided.\n\nExclusion Criteria:\n\n* Participants screen positive for alcohol (AUDIT) or substance abuse (DUDIT).\n* Psychotic symptoms, ongoing manic episode, acute suicidality.\n* If ongoing medication has an impact on the physiological data (ECG) recorded during the social paradigms, physiological data will be excluded from the analyses (but not exclusion for the treatment).\n* Have current (pre-assessment) ongoing psychological treatment focusing on social safeness, PTSD or complex PTSD.","100 Years",{"count":60,"type":21},50,[24],"This Pilot Randomized Controlled Trial (RCT) overall aim is to establish the safety, feasibility, acceptability and preliminary effects of a body-oriented psychotherapy, Somatic Experiencing (SE), on social functioning and mental health among adults with a history of Child Maltreatment (CM) and symptoms of posttraumatic stress disorder (PTSD) or complex posttraumatic stress disorder (CPTSD). Participants will be randomized either to an SE-group (n=25, psychoeducation, and information about treatment possibilities + 15-session SE treatment) or to a control group (n=25, same psychoeducation and information about treatment possibilities + regular phone calls to provide updates on their well-being and if they started a treatment). Given the lack of research on the effect of SE on Psychological Safety in this population, while SE has not yet been introduced into the Swedish health care system, special consideration will be given to participant safety, feasibility and acceptability of the SE-treatment. This includes monitoring (and assessing) for serious adverse events (SAEs) and adverse events (AEs), if conducting an RCT on SE in our target sample is feasible (e.g., achieving the target sample goal, assessing attrition rates and session attendance) and the acceptance of the used SE intervention (e.g., positive evaluations and willingness to recommend the treatment). Next to assessing safety, feasibility and acceptability, preliminary outcomes (self-report and experimental measures) will be evaluated at pre-treatment, post-treatment (20 weeks after pre), and at a 20-week follow-up, assessing primary outcomes (Psychological Safety) and secondary outcomes (Social Safeness, PTSD, CPTSD, Depression), as well as additional factors (e.g., interoception) that could contribute to decreased mental health and social functioning issues. Additionally, participants' behavioral (e.g., interpersonal distance) and physiological responses (HR, HRV, EDA) to social stimuli will be assessed pre- and post-treatment in an experimental setup to explore SE's potential to reduce Negative Affect and increase Positive Affect (Activated, Relaxed, Safe\u002FContent) in response to social stress.",[64,65,29,66,67,68],"Safety, Psychological","Acceptability of Health Care","Maltreatment, Child","Post Traumatic Stress Disorder","Complex Post-Traumatic Stress Disorder",[70,71,72,73,74,75,76,77,78,79,80],"Safety","Feasibility","Body-oriented intervention","Somatic Experiencing","Psychological safety","Social safeness","Childhood maltreatment","Post traumatic stress disorder","Complex Post traumatic stress disorder","Interoception","Depression","2024-10-11",{"date":83,"type":42},"2024-10-15",{"date":85,"type":42},"2024-09-06",{"date":87,"type":21},"2026-11",{"name":89,"class":90},"Monique Pfaltz","OTHER",1]