RecruitingNAINTERVENTIONAL

PARO-agitation-study

This study investigates if a robotic seal called PARO can help patients recover more comfortably after planned abdominal (visceral) surgery. Many people feel restless, anxious, or pain after these operations, which can make their hospital stay longer. PARO is a seal-shaped robot that interacts with patients through touch, sound, and movement. Researchers want to see if using PARO can reduce these feelings of agitation, pain, and anxiety. They will compare patients who use PARO with those who don't, carefully checking how PARO works and how well hospitals can use it safely and effectively.

At a glance

Status

Recruiting

Phase

Sponsor

Hannover Medical School

Enrolment target

300

Start

15 Dec 2025

Estimated completion

01 May 2027

Agitation POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE Anxiety After Surgery Postoperative Pain

What is this study about?

When you have surgery, especially a big one like abdominal surgery, it's common to feel restless, anxious, or even a bit confused afterwards. This is called 'postoperative agitation' and it can make your recovery harder, sometimes leading to a longer stay in hospital. Doctors are always looking for better ways to help patients feel more comfortable and recover faster after their operations.

This study is looking at a new and gentle approach: a friendly, cuddly robotic seal called PARO. Imagine a soft, interactive seal that responds to your touch and voice. PARO is designed to recognise human interaction through sensors and special computer programs. The idea is that by interacting with PARO, patients might feel calmer, less anxious, and more at ease. The study wants to see if using PARO can help reduce those feelings of restlessness and make recovery smoother for patients undergoing planned abdominal surgery.

To find this out, researchers will carefully watch patients who use PARO compared to those who don't. They will check for signs of agitation, how much pain people feel, and levels of anxiety. They'll also observe how patients interact with PARO and how easily hospital staff can use it safely and hygienically. The main goal is to see if PARO can genuinely improve recovery after surgery by making patients more comfortable.

Key takeaways

New study testing if a robotic seal (PARO) can help patients after surgery.
Aims to reduce restlessness, pain, and anxiety after abdominal operations.
Compares patients using PARO with those who don't.
Involves observations and assessments for a few days post-surgery.
Participation is voluntary and will not affect medical care.

Who may be eligible?

To take part in this study, you must be at least 18 years old and having a planned abdominal (visceral) surgery. You also need to speak German and be able to understand and agree to take part in the study yourself.

There are certain reasons why you might not be able to join. These include if you already have dementia, a weakened immune system, or are unable to hear. You also can't take part if you have a current serious infection, a history of drug dependency, or a long-lasting pain condition. The study also excludes people with certain types of severe infections or those who became seriously ill after surgery.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having planned abdominal surgery?
Are you fluent in German?
Can you understand and give your own consent?
Do you have a healthy immune system?
Do you not currently have a serious infection?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be involved in regular checks for three days after your surgery. A trained study team will assess your level of agitation using a simple scale twice a day. They will also ask about your pain levels and anxiety using standard tools. If you are in the group using PARO, your interactions with the robotic seal will be observed through sensors in the robot and video recordings to see how you respond. The study also includes checking various other aspects of your recovery and potential complications.

Potential risks and benefits

Participating in this study might offer the benefit of potentially feeling less agitated and more comfortable after your surgery if PARO proves helpful. While PARO is a medical device, it is designed for safe interaction and the study includes strict hygiene protocols. There are no additional invasive procedures involved beyond standard care. You are absolutely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Medical School Hannover
Verified postcode
Hanover, Germany· Recruiting

Common questions

What is PARO?

PARO is a robotic seal designed to interact with people. It has sensors and uses clever technology to respond to touch, sound, and movement, like a friendly pet.

What kind of surgery is this study for?

This study is for adults who are having planned surgery on their internal organs in the tummy area (abdominal or visceral surgery).

Will I have to take extra medication?

No, this study does not involve any extra medication. It focuses on the use of the PARO robotic seal and observations during your usual recovery.

How long does the study last for each patient?

Your involvement in the study's assessments will mostly take place during the first three days after your surgery.

Is PARO safe to use in a hospital?

Yes, the study includes carefully planned hygiene procedures to make sure PARO can be used safely and cleanly in a hospital environment.

How to find out more

Hans Worthmann, PD Dr.

worthmann.hans@mh-hannover.de +495115322393 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.