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Enrolling by invitation NCT07506330

The SENSE Study: Surgical ENvironment Stress Evaluation

— Observational Stress

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: total joint arthroplasty, total joint arthroplasty.
Who it may be relevant to
Registry conditions: Stress. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • Procedure total joint arthroplasty
    robotic assisted total joint arthroplasty
  • Procedure total joint arthroplasty
    conventional total joint arthroplasty

Primary outcome measures

  • Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system [Time frame: Pre-procedure]
  • Task-evoked changes in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) measured using the Brite functional near-infrared spectroscopy (fNIRS) system [Time frame: Perioperative/Periprocedural]
  • 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]
  • Perceived stress assessed using the Perceived Stress Scale (PSS) [Time frame: Pre-procedure]
  • Perceived stress assessed using the Perceived Stress Scale (PSS) [Time frame: Immediately after the procedure]
  • Sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ) [Time frame: Pre-procedure]
  • Change in oxygenated (HbO₂) and deoxygenated haemoglobin (HHb) during control/simple task conditions measured using the Brite fNIRS system [Time frame: Perioperative/Periprocedural]
  • Heart rate measured using electrocardiography (ECG) [Time frame: Pre-procedure]
  • Heart rate measured using electrocardiography (ECG) [Time frame: Perioperative/Periprocedural]
  • Heart rate measured using electrocardiography (ECG) [Time frame: Immediately after the procedure]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • UCL Hospitals NHS Foundation Trust — London

Identifiers

NCT: NCT07506330 · 182510

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗