The SENSE Study: Surgical ENvironment Stress Evaluation

NCT07506330 | Not Yet Recruiting

• 1 other identifier: 182510
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (4)

• 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

  From enrollment for 6 months continuous monitoring

• Physiological stress measured via breathing rate on Garmin smartwatch

  From enrollment for 6 months continuous monitoring

Study Arms (1)

6 adult hip and knee specialist Orthopaedic surgeons

Procedure: total joint arthroplasty

Interventions

total joint arthroplasty PROCEDURE

robotic assisted total joint arthroplasty

6 adult hip and knee specialist Orthopaedic surgeons

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male and female
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

UCL Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

MeSH Terms

Interventions

Arthroplasty, Replacement

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Flaminia Ronca, PhD

  UCL Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Flaminia Ronca, PhD

CONTACT

+442034479413; f.ronca@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: April 1, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)