PARO-agitation-study

Postoperative Agitation, Anxiety and Pain With the Use of the Robotic Tool PARO - A Prospective Randomised Study

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).

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Agitation; POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE; Anxiety After Surgery
• Intervention / Treatment: Device: PARO

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hans Worthmann, PD Dr.; Phone Number: +495115322393; Email: worthmann.hans@mh-hannover.de
• Study Contact Backup: Name: Johannes Teller, Dr.; Phone Number: +495115323580; Email: teller.johannes@mh-hannover.de

Study Locations

• Germany
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30449
      • Recruiting
      • Medical School Hannover
      • Contact: Hans Worthmann, PD Dr.; Phone Number: +495115322393; Email: worthmann.hans@mh-hannover.de
      • Contact: Johannes Teller, Dr.; Phone Number: +495115323580; Email: teller.johannes@mh-hannover.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Other: Standard of care + PARO	Device: PARO; Robotic Seal "PARO"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agitation	measured via Richmond-agitation-sedation-scale (RASS)	1.-3.postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative anxiety	measured via State-Trait-Anxiety-Inventory (STAI)	Postoperative days 1-3
Postoperative pain	measured via Numeric-Rating-scale (NRS)	Postoperative days 1-3
Postoperative delirium	measured via 3D-CAM/CAM-ICU	Postoperative days 1-3

Collaborators and Investigators

• Sponsor: Hannover Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Agitation, postoperative Delirium, Anxiety
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Pain; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Behavioral Symptoms; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Emergence Delirium; Pain, Postoperative; Anxiety Disorders; Psychomotor Agitation
• Other Study ID Numbers: 12013-BO-S-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data that support the findings of this study are available, but restrictions apply to the availability of these data, which were used under licence for the current study and so are not publicly available. The data are, however, available from the authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No