StressSENSENCT07506330
The SENSE Study: Surgical ENvironment Stress Evaluation
An observational study of Stress, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress
- What is being tested?
- total joint arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All will be based at the single-study site: orthopaedic department of tertiary referral NHS hospital
Who may be able to join
- 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.
Who cannot join
- History neurological disorders
- History traumatic brain injury
- History cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
UCL Hospitals NHS Foundation Trust
London, NW1 2PG
About this study
Official 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
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
- Being tested
- total joint arthroplasty
- Keywords
- cognitive workloads, physiological stress biomarkers, functional near-infrared spectroscopy, multimodal brain-body data integration, robotic assisted arthroplasty, total hip arthroplasty, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total joint arthroplastyProcedure or surgery
robotic assisted total joint arthroplasty
total joint arthroplastyProcedure or surgery
conventional total joint arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| 6 adult hip and knee specialist Orthopaedic surgeons | Not described Receives: Procedure: total joint arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the procedure
Secondary outcomes (4)
Sleep quality as assessed via Garmin smartwatch looking at number of hours
Measured: From enrollment for 6 months continuous monitoring
Physiological stress measured via heart rate variability - HRV - on a Garmin smartwatch
Measured: 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.
Measured: From enrollment for 6 months continuous monitoring
Physiological stress measured via breathing rate on Garmin smartwatch
Measured: From enrollment for 6 months continuous monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Flaminia Ronca, PhD, Principal investigator, UCL Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506330
- Sponsor's protocol ID
- 182510
- Acronym
- SENSE
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07506330
- Acronym / sponsor ID
- SENSE / 182510
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 6 adult hip and knee specialist Orthopaedic surgeons | – | Procedure: total joint arthroplasty |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All will be based at the single-study site: orthopaedic department of tertiary referral NHS hospital
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- History neurological disorders
- History traumatic brain injury
- History cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total joint arthroplastyrobotic assisted total joint arthroplasty | Procedure or surgery | 6 adult hip and knee specialist Orthopaedic surgeons |
| total joint arthroplastyconventional total joint arthroplasty | Procedure or surgery | 6 adult hip and knee specialist Orthopaedic surgeons |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Sleep quality as assessed via Garmin smartwatch looking at number of hours
Time frame: From enrollment for 6 months continuous monitoring
Physiological stress measured via heart rate variability - HRV - on a Garmin smartwatch
Time frame: From enrollment for 6 months continuous monitoring
Duration of physical activity measured using Garmin wearable devices
Time frame: From enrollment for 6 months continuous monitoring
Physiological stress measured via breathing rate on Garmin smartwatch
Time frame: From enrollment for 6 months continuous monitoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Flaminia Ronca, PhD principal investigator
UCL Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.