The SENSE Study: Surgical ENvironment Stress Evaluation (SENSE)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Stress
• Intervention / Treatment: Procedure: total joint arthroplasty; Procedure: total joint arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 6

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2PG
    • UCL Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All will be based at the single-study site: orthopaedic department of tertiary referral NHS hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
6 adult hip and knee specialist Orthopaedic surgeons	Procedure: total joint arthroplasty; robotic assisted total joint arthroplasty; Procedure: total joint arthroplasty; conventional total joint arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system	The 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.	Pre-procedure
Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system	The 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.	Perioperative/Periprocedural
Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system	The 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.	Immediately after the procedure
Perceived stress assessed using the Perceived Stress Scale (PSS)	Perceived 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.	Pre-procedure
Perceived stress assessed using the Perceived Stress Scale (PSS)	Perceived 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.	Immediately after the procedure
Sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ)	Sleep 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.	Pre-procedure
Change in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) during control/simple task conditions measured using the Brite fNIRS system	The 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.	Perioperative/Periprocedural
Heart rate measured using electrocardiography (ECG)	Heart 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.	Pre-procedure
Heart rate measured using electrocardiography (ECG)	Heart 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.	Perioperative/Periprocedural
Heart rate measured using electrocardiography (ECG)	Heart 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.	Immediately after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep quality as assessed via Garmin smartwatch looking at number of hours		From enrollment for 6 months continuous monitoring
Physiological stress measured via heart rate variability - HRV - on a Garmin smartwatch		From enrollment for 6 months continuous monitoring
Duration of physical activity measured using Garmin wearable devices	Physical 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.	From enrollment for 6 months continuous monitoring
Physiological stress measured via breathing rate on Garmin smartwatch		From enrollment for 6 months continuous monitoring

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Flaminia Ronca, PhD, UCL Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: total hip arthroplasty; total knee arthroplasty; functional near-infrared spectroscopy; cognitive workloads; physiological stress biomarkers; multimodal brain-body data integration; robotic assisted arthroplasty
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement
• Other Study ID Numbers: 182510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No