AgitationNCT07568093
PARO-agitation-study
A study testing PARO in people with Agitation and POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agitation, POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, Anxiety After Surgery
- What is being tested?
- PARO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Medical School Hannover
Hanover, Lower Saxony, 30449
Hans Worthmann, PD Dr., +495115322393, worthmann.hans@mh-hannover.de
Johannes Teller, Dr., +495115323580, teller.johannes@mh-hannover.de
About this study
Official title: 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.
Read more
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).
- Conditions
- Agitation, POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, Anxiety After Surgery, Postoperative Pain
- Being tested
- PARO
- Keywords
- Agitation, postoperative Delirium, Anxiety
- Medical subject headings
- Psychomotor Agitation, Pain, Postoperative, Emergence Delirium, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARODevice
Robotic Seal "PARO"
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Not described |
| Standard of care + PARO | Other | Not described Receives: Device: PARO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agitation
measured via Richmond-agitation-sedation-scale (RASS)
Measured: 1.-3.postoperative days
Secondary outcomes (3)
Postoperative anxiety
measured via State-Trait-Anxiety-Inventory (STAI)
Measured: Postoperative days 1-3
Postoperative pain
measured via Numeric-Rating-scale (NRS)
Measured: Postoperative days 1-3
Postoperative delirium
measured via 3D-CAM/CAM-ICU
Measured: Postoperative days 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start15 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Worthmann, Hans MD, MHBA, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568093
- Sponsor's protocol ID
- 12013-BO-S-2025
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Agitation, Anxiety and Pain With the Use of the Robotic Tool PARO - A Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT07568093
- Acronym / sponsor ID
- 12013-BO-S-2025
- Conditions
- Agitation, POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, Anxiety After Surgery, Postoperative Pain
- Keywords
- Agitation, postoperative Delirium, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | – |
| Standard of care + PARO | Other | Device: PARO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARORobotic Seal "PARO" | Device | Standard of care + PARO |
Primary outcome
Agitation
Time frame: 1.-3.postoperative days
measured via Richmond-agitation-sedation-scale (RASS)
3 secondary outcomes
Postoperative anxiety
Time frame: Postoperative days 1-3
Postoperative pain
Time frame: Postoperative days 1-3
Postoperative delirium
Time frame: Postoperative days 1-3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided. 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.
Related trials for Agitation
Not yet recruiting
Virtual Reality to Advance Dementia Care and Quality of Life
Dementia, Agitation
Not yet recruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Recruiting
Virtual Darkness Theraphy for Agitation in Dementia
Agitation in Dementia, Including Alzheimer's Disease
Active, not recruitingPhase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Delirium, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARO in people with Agitation and POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hans Worthmann, PD Dr. (+495115322393, worthmann.hans@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agitation (time frame: 1.-3.postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.