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

NCT05884385 | Completed

• 1 other identifier: DEV046
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 1.EMG measurements of frequency and amplitude across muscle fibres.
2. 2.EEG measurements of peak alpha power, and alpha spindle duration and amplitude.

Conditions

Cognitive Deficit in Attention; Musculoskeletal Strain; Fatigue; Surgery

Keywords

Robot-assisted Laparoscopic surgery; Warm up; Mental Visualisation

Outcome Measures

Primary Outcomes (2)

• Muscle demands

  EMG measurements of Maximal Voluntary Contraction (MVC) changes across points of interest to establish the musculoskeletal demands of RALS.

  20 weeks

• Cognitive demands

  EEG measurements of alpha activity during RALS to determine changes in cognitive demands.

  20 weeks

Study Arms (3)

No intervention

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

EXPERIMENTAL

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.

Other: Simulated exercises

Mental Visualisation

EXPERIMENTAL

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.

Other: Mental Visualisation

Interventions

Simulated exercises OTHER

as detailed in arm description

Simulated exercises

Mental Visualisation OTHER

as detailed in arm description

Mental Visualisation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lancaster University: lead
• East Lancashire Hospitals NHS Trust: collaborator

Study Sites (1)

East Lancashire Hospitals NHS Trust

Blackburn, Lancashire, BB2 3HH, United Kingdom

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (MD Student)

Model Details: Surgeons will perform 3 surgical procedures under 3 randomized conditions: no intervention, simulated exercises, and mental visualization. EMG and EEG monitoring will be performed to collect data at predefined POIs. Condition 1 involves no changes to their regular robotic procedure, while Condition 2 has surgeons perform simulated tasks before surgery. In Condition 3, surgeons undergo mental training scripts before performing surgery, which involves guided mental visualization. The study aims to investigate the effects of these conditions on surgical performance.

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: June 1, 2023
• Study Start: May 30, 2023
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

GB (1)