Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07506330
Acronym
SENSE
Enrollment
6
Registered
2026-04-01
Start date
2026-04-01
Completion date
2028-03-01
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Keywords

cognitive workloads, physiological stress biomarkers, functional near-infrared spectroscopy, multimodal brain-body data integration, robotic assisted arthroplasty, total hip arthroplasty, total knee arthroplasty

Brief 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.

Interventions

PROCEDUREtotal joint arthroplasty

robotic assisted total joint arthroplasty

Sponsors

University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Male and female * 18-65 years * Orthopaedic surgeon * Experienced in both conventional and robotic total hip and knee arthroplasty and partial knee arthroplasty * Willing and able to provide informed consent.

Exclusion criteria

* History neurological disorders * History traumatic brain injury * History cognitive impairment

Design outcomes

Primary

MeasureTime frameDescription
Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) systemPre-procedureThe primary outcome is task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) concentrations measured using the Brite functional near-infrared spectroscopy system (Artinis Medical Systems).Baseline HbO₂ and HHb values will be used to normalise task-evoked activity and control for non-task-evoked physiological changes. fNIRS signals will be pre-processed using standard pipelines (including motion artifact correction, filtering, and conversion to concentration changes using the Modified Beer-Lambert Law) implemented in MATLAB with established fNIRS toolboxes. Data will be reported as relative concentration changes (ΔHbO₂, ΔHHb) during task versus baseline periods. Cognitive load will be operationalised as task-related changes in HbO₂ and HHb concentrations.
Perceived stress assessed using the Perceived Stress Scale (PSS)Pre-procedurePerceived stress will be assessed using the Perceived Stress Scale (PSS), a validated self-report questionnaire. The PSS total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
Sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ)Pre-procedureSleep quality will be assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ). The LSEQ consists of visual analogue scales assessing domains including ease of getting to sleep, quality of sleep, ease of awakening, and behavior following wakefulness. Scores are typically transformed to a 0-100 scale, with higher scores indicating better perceived sleep quality.
Change in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) during control/simple task conditions measured using the Brite fNIRS systemPerioperative/PeriproceduralThe primary outcome is task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) concentrations measured using the Brite functional near-infrared spectroscopy system (Artinis Medical Systems). Data will be reported as relative concentration changes (ΔHbO₂, ΔHHb) in micromolar (µM), derived using the Modified Beer-Lambert Law. A standardized low-complexity control task (glove donning and doffing) will be performed to provide baseline physiological measurements. HbO₂ and HHb signals recorded during this control condition will be used for comparison with higher-demand task conditions. Cognitive load will be operationalized as differences in HbO₂ and HHb responses between control and task conditions.
Heart rate measured using electrocardiography (ECG)Pre-procedureHeart rate (HR) will be measured using electrocardiography (ECG) via surface electrodes. HR will be recorded in beats per minute (bpm) during baseline, control, and task conditions. Changes in HR (bpm) from baseline will be calculated, with increases in HR interpreted as reflecting greater physiological stress.

Secondary

MeasureTime frameDescription
Sleep quality as assessed via Garmin smartwatch looking at number of hoursFrom enrollment for 6 months continuous monitoring
Physiological stress measured via heart rate variability - HRV - on a Garmin smartwatchFrom enrollment for 6 months continuous monitoring
Duration of physical activity measured using Garmin wearable devicesFrom enrollment for 6 months continuous monitoringPhysical activity will be monitored using Garmin wearable devices. The outcome measure is the total duration of physical activity, recorded in hours per week, based on device-derived activity data. Higher values indicate greater levels of physical activity.
Physiological stress measured via breathing rate on Garmin smartwatchFrom enrollment for 6 months continuous monitoring

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORFlaminia Ronca, PhD

UCL Hospitals NHS Foundation Trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026