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Enrolling by Invitation

NCT Number: NCT07506330

The SENSE Study: Surgical ENvironment Stress Evaluation

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.

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Key information

Conditions

Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCL Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total joint arthroplasty

Procedure

robotic assisted total joint arthroplasty

Primary outcomes

  1. Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system

    Time frame: Pre-procedure

    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.

  2. Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system

    Time frame: Perioperative/Periprocedural

    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.

  3. Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system

    Time frame: Immediately after the procedure

    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.

  4. Perceived stress assessed using the Perceived Stress Scale (PSS)

    Time frame: Pre-procedure

    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.

  5. Perceived stress assessed using the Perceived Stress Scale (PSS)

    Time frame: Immediately after the procedure

    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.

  6. Sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ)

    Time frame: Pre-procedure

    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.

  7. Change in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) during control/simple task conditions measured using the Brite fNIRS system

    Time frame: Perioperative/Periprocedural

    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.

  8. Heart rate measured using electrocardiography (ECG)

    Time frame: Pre-procedure

    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.

  9. Heart rate measured using electrocardiography (ECG)

    Time frame: Perioperative/Periprocedural

    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.

  10. Heart rate measured using electrocardiography (ECG)

    Time frame: Immediately after the procedure

    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.

Secondary outcomes

  1. Sleep quality as assessed via Garmin smartwatch looking at number of hours

    Time frame: From enrollment for 6 months continuous monitoring

  2. Physiological stress measured via heart rate variability - HRV - on a Garmin smartwatch

    Time frame: From enrollment for 6 months continuous monitoring

  3. Duration of physical activity measured using Garmin wearable devices

    Time frame: From enrollment for 6 months continuous monitoring

    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.

  4. Physiological stress measured via breathing rate on Garmin smartwatch

    Time frame: From enrollment for 6 months continuous monitoring

Sponsors and collaborators

Lead sponsor

University College, London

Other

Registry information

Official study title

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

Acronym: SENSE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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