| NCT ID | NCT07568093 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hannover Medical School |
| Condition | Agitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-12-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 also be assessed. Additionally, the interaction between PARO and the patients is analyzed regarding movements, reactions to haptic and auditory stimuli, and the frequency of interaction. Our approach involves quantitatively monitoring these metrics to collect sensor data from the robot and video recordings of the patients to identify facial expression and posture patterns. The use and acceptance of the robot on clinical wards by various professional groups are evaluated. The focus is particularly on nursing staff, who have the most interactions with patients. The project is complemented by a hygiene study examining how successfully the hygiene protocol is integrated into clinical routines and what challenges the use of PARO poses in an intensive care unit. The aim is also to examine the workflow and time-related aspects of its usage. The study will be submitted as a clinical trial of the medical device within its intended use, without any additional invasive or burdensome procedures, in accordance with the provisions of Section 15 of the Medical Practitioners Act (MBO).
Eligibility Criteria
Patient inclusion criteria: * ≥18 years of age * Elective visceral surgery * german-speaking * Patient is capable of giving informed consent Patient exclusion criteria: * Known dementia * Known immunodeficiency * Anacusia * Acute damage to the central nervous system * A preoperative systemic infection * Pre-existing severe immunosuppression or colonization with multidrug-resistant organisms (methicillin resistant Staphylococcus aureus (MRSA), quadruple multidrug-resistant Gram-negative pathogens (MRGN), Candida auris, vancomycin-resistant enterococci (VRE), and linezolid-resistant enterococci (LRE)) * Postoperative systemic infection * Drug dependence * Known chronic pain syndrome
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07568093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Agitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07568093 currently recruiting?
Yes, NCT07568093 is actively recruiting participants. Contact the research team at worthmann.hans@mh-hannover.de for enrollment information.
Where is the NCT07568093 trial being conducted?
This trial is being conducted at Hanover, Germany.
Who is sponsoring the NCT07568093 clinical trial?
NCT07568093 is sponsored by Hannover Medical School. The trial plans to enroll 300 participants.