Exploring the Effect of Pre-surgery Simulated Warm-up and Mental Visualisation in Reducing Musculoskeletal and Cognitive Demands Experienced by Surgeons Performing Robot-assisted Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Cognitive demands
研究概览
简要总结
Study Design - A Counterbalanced Study
Aims - To determine the effect of a) warm-up exercises and b) mental visualisation on the musculoskeletal demands and cognitive demands respectively during robot-assisted laparoscopic surgery.
Outcome Measures -
- EMG measurements of frequency and amplitude across muscle fibres.
- EEG measurements of peak alpha power, and alpha spindle duration and amplitude.
Study Participants and Eligibility - Surgeons who have certificates of completion of training (CCT) and performing surgical procedures using the minimally invasive techniques of RALS.
Planned Size of Sample - The investigators have chosen the higher value for our power calculation (an effect size of 0.24) which requires 10 surgeons per condition performing 1 - 2 operations for 80% power to detect a difference between conditions, at an alpha of 0.05.
Planned Study Period-Duration - Each surgeon will be required to participate in the study for approximately 3 - 4 weeks performing 3 surgical procedures and based on estimates that surgeons routinely perform an average of 1 robotic procedure per week it is anticipated the study will run for 6 months.
Research Question - Does structured simulated warm-up exercises prior to performing surgery improve surgeons' ergonomic awareness and maintain the low muscle fatigue impact associated with RALS? The investigators also hypothesize that mental imagery, inducing a flow state associated with overall cortical synchronisation could decrease cognitive demands experienced by surgeons and potentially mitigate against the cognitive fatigue surgeons experience whilst performing procedures.
详细描述
BACKGROUND There is an increased utilisation of minimally invasive surgery (MIS) by virtue of it being more beneficial to patients, however, an increase in musculoskeletal (MSK) demands is observed when the modality of standard laparoscopic (LS) techniques are used compared with robot-assisted laparoscopic techniques (RALS). Studies have further highlighted that RALS is significantly associated with decreased musculoskeletal demands for surgeons, including findings from our recent study exploring the demands of RALS and LS surgery (MURALS study - NCT04477746).
Although most studies additionally observe that surgeons experienced less cognitive demands with RALS, the MURALS study on the other hand found that the favourable MSK effects associated with RALS come with a "cost" of concomitantly increasing surgeons' attentional demands. This finding is associated with the design of the robotic console's viewing cart which has a binocular design displaying high-definition 3-dimensional images similar to virtual reality headsets, thereby requiring fusion of images from both eyes to produce clear images of the operating field through the process of stereopsis. Also, this design of the viewing cart additionally acts to isolate the visual senses and block out other distractions within the surgeon's visual field.
The modern technology of RALS, therefore, offers better ergonomic advantages which could protect surgeons from adverse MSK effects and potentially prolong their surgical careers. The consequent effect of this would be an increase in the years' surgeons remain in active duty thereby being able to operate and provide life-changing treatments to an additional number of patients over the span of their careers.
Warm-up exercises, such as aerobic or stretching exercises and performing simulated tasks, all represent types of interventions associated with improved task performance, decreased completion times, and reduced errors. Warm-up exercises are routinely practiced by athletes before competing and amongst musicians and dancers prior to performances which are complex psychomotor tasks requiring high cognitive function and coordinated motor skill. Similarly, surgeons performing fundamental surgical skills like suturing performed simulations on mobile devices or on surgical simulators prior to being assessed using validated global rating scales like the Kundhal or Reznick scale demonstrated improved task performance, also consistent with the findings in a systematic review on the effect of warm-up exercises on surgical performance.
Another simple and inexpensive tool utilised by athletes to enhance performance is mental visualisation or mental imagery which is the cognitive rehearsal of tasks in the absence of physical movements for the purpose of mental rehearsal, relaxation or goal-setting purposes. Whilst athletes experience a myriad of different mental states during task performance, this technique of mental imagery has been shown to improve optimal performance in athletes by inducing, a flow state - which is characterized by automatic information processing without conscious thinking by suppressing prefrontal cortex activity temporarily. There is also an association between mental imagery and an observed greater power of alpha waves especially associated with the parietal (somatosensory processes) and occipital (visual processes) cortex. Studies in neurophysiology have clearly established that the neuroplastic changes observed during mental visualisation are similar to those which occur when physically performing tasks, due to the fact that performed or imagined movements stimulate the same neurons, engaging comparable patterns of connectivity between cortical motor regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age above 18 years (Adult participants)
- •Surgeons who have acquired their certificate of completion of training (CCT)
- •Surgeons with experience in performing procedures using RALS.
排除标准
- •Surgeons with significant physical and musculoskeletal health conditions that would impede optimal performance of surgical procedures (e.g., severe arthritis, traumatic bony or soft tissue injuries)
- •Surgeons with significant musculoskeletal pain or stiffness that would impede optimal performance of surgery.
- •Surgeons with any cognitive symptoms like poor motor coordination, Loss of memory, visual disturbances, or headaches.
- •Surgeons on any medications altering cognitive function like Psychoactive drugs, antidepressants and anticonvulsants
研究组 & 干预措施
No intervention
Surgeons performing procedures under this condition will receive no intervention. They will perform the robotic procedure as they would normally on a day-to-day basis without any change. EMG and EEG monitoring will be performed by collecting data at the various predefined POIs.
Simulated exercises
When surgeons perform procedures under this condition they perform the initial theatre briefing prior to starting an operating list. They then perform 5 minutes of a preloaded simulated task on the robotic console. These tasks are designed to emulate fundamental skills required to perform robot-assisted laparoscopic surgery. They will then proceed to perform surgery as they normally do whilst undergoing EMG and EEG motoring, collecting data at the predefined POIs.
干预措施: Simulated exercises (Other)
Mental Visualisation
Mental training scripts based on the different surgical procedures performed by the different specialties were developed using the Mackay nodal model of mental practice(34). This involves breaking down a task into individual steps called nodal points with detailed instructions which also incorporate sensory cues to enhance the mental representation in the eye of participants' minds.
On the day of surgery, surgeons performing the procedure under this condition will consent to patients for their robotic procedure and then proceed to perform the initial theatre briefing prior to starting am operating list.
After this, surgeons will then perform 5 minutes of guided mental visualisation rather than self-produced imagery will be performed using the mental training scripts. They will then proceed to perform surgery as they normally do whilst undergoing EMG and EEG motoring, collecting data at the predefined POIs.
干预措施: Mental Visualisation (Other)
结局指标
主要结局
Cognitive demands
时间窗: 20 weeks
EEG measurements of alpha activity during RALS to determine changes in cognitive demands.
Muscle demands
时间窗: 20 weeks
EMG measurements of Maximal Voluntary Contraction (MVC) changes across points of interest to establish the musculoskeletal demands of RALS.
次要结局
未报告次要终点
研究者
Abdulwarith Shugaba
Principal Investigator (MD Student)
Lancaster University
