Набор по приглашению NCT07506330

The SENSE Study: Surgical ENvironment Stress Evaluation

— Наблюдательное Stress

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: total joint arthroplasty, total joint arthroplasty.
Кому может быть актуально: Состояния в реестре: Stress. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Процедура total joint arthroplasty
robotic assisted total joint arthroplasty
Процедура total joint arthroplasty
conventional total joint arthroplasty

Первичные конечные точки

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

Вторичные конечные точки (4)

Sleep quality as assessed via Garmin smartwatch looking at number of hours [Срок оценки: From enrollment for 6 months continuous monitoring]
Physiological stress measured via heart rate variability - HRV - on a Garmin smartwatch [Срок оценки: From enrollment for 6 months continuous monitoring]
Duration of physical activity measured using Garmin wearable devices [Срок оценки: From enrollment for 6 months continuous monitoring]
Physiological stress measured via breathing rate on Garmin smartwatch [Срок оценки: From enrollment for 6 months continuous monitoring]

Критерии участия

Критерии включения

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.