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Enrolling By InvitationNCT07506330

The SENSE Study: Surgical ENvironment Stress Evaluation

The SENSE Study: Surgical ENvironment Stress Evaluation. Utilising Brain fNIRS to Evaluate Cognitive and Physical Stress in Surgical Leads During Conventional and Robotic Arthroplasty

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
6 (estimated)
Sponsor
University College, London · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

Surgical procedures such as total hip and knee arthroplasty require a complex set of physical and cognitive skills, expert execution, and inevitably place a high stress load on the surgeon. While the primary focus of healthcare is typically aimed at the patient, the high physical and mental stress placed on surgeons is of equal significance and should be addressed in order to support surgical teams. Robot-assisted surgery is purported to improve surgical outcomes for both patients and surgeons, particularly by improving surgical efficiency and reducing physical and cognitive load on the surgeon. This stress load typically requires a combination gross and fine motor skills, physical exertion, spatial cognition, executive functioning, inhibitory-control, decision-making, communication and team management. Robotic assistance can reduce some of the cognitive load experienced during these processes, although it is also likely to be replaced by new thought-processes (e.g. numerical reasoning, coordinating screen and patient inputs, etc) that require equally important levels of training and expertise. Numerous studies have explored the effects of conducting surgery on surgeon stress, but these are largely limited to measuring heart rate variability. A few research groups have implemented fNIRS brain imaging in surgical settings to study the effects of different operating methods on cognitive stress in clinicians, demonstrating the potential of this technology in understanding more about cognitive processes and cognitive load involved in surgery. However, these have not yet been implemented in the context of orthopaedic surgery.

Conditions

Interventions

TypeNameDescription
PROCEDUREtotal joint arthroplastyrobotic assisted total joint arthroplasty
PROCEDUREtotal joint arthroplastyconventional total joint arthroplasty

Timeline

Start date
2026-04-01
Primary completion
2028-03-01
Completion
2028-03-01
First posted
2026-04-01
Last updated
2026-04-07

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT07506330. Inclusion in this directory is not an endorsement.