CompletedNot Applicable

Effect of Surgeon Warm-up and Mental Visualisation During Robot-assisted Laparoscopic Surgery

United Kingdom10 participantsStarted 2023-05-30

Plain-language summary

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 - 1. EMG measurements of frequency and amplitude across muscle fibres. 2. 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Muscle demands

Timeframe: 20 weeks

Cognitive demands

Timeframe: 20 weeks

Trial details

NCT IDNCT05884385

SponsorLancaster University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-30

View on ClinicalTrials.gov More Cognitive Deficit in Attention trials