Condition: Agitation · POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE · Anxiety After Surgery · Sponsor: Hannover Medical School
Postoperative agitation is a common and serious complication in visceral and transplant surgery, associated with prolonged hospital stays and an increased risk of self-harm. Therefore, it is important to find an approach to improve the management of postoperative agitation and to reduce its duration and severity. The medical device "PARO" is a robotic seal that enables patient-robot-interaction. Patients respond to the device through verbal communication and motor responses, as well as facial expressions and gestures. The seal detects human interaction through audiovisual recognition, tactile sensors, and the integration of artificial intelligence. The aim of the study is to observe the use of "PARO" in patients undergoing elective visceral surgery and to analyze the occurence of agitation. A decrease in the incidence of postoperative agitation is to be expected in a cohort of patients undergoing visceral surgery who use PARO compared to a group of patients undergoing visceral surgery who do not use PARO. To monitor the occurrence of postoperative agitation, a standardized screening will be conducted twice daily for three days using the Richmond Agitation-Sedation Scale (RASS). To assess postoperative pain, anxiety and delirium, the Numerical Pain Scale (NRS), the State-Trait-Anxiety-Inventory (STAI) and a delirium screening tool (3D-CAM/CAM-ICU) are used by a trained study team. The occurrence of other neuropsychiatric symptoms and postoperative surgical complications will…
This description comes directly from the study's public registry record.
Hans Worthmann, PD Dr. · +495115322393 · worthmann.hans@mh-hannover.de
Johannes Teller, Dr. · +495115323580 · teller.johannes@mh-hannover.de
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| Medical School Hannover | Hanover, Lower Saxony, Germany | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07568093