NCT05884385: MURALS2

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

Completed NA Last updated 28 August 2024

What this trial tests

NA trial testing Simulated exercises in Cognitive Deficit in Attention in 10 participants. Completed in 30 August 2023.

Timeline

30 May 2023

Primary endpoint
30 August 2023

30 August 2023

Quick facts

Lead sponsor	Lancaster University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	prevention
Enrollment	10
Start date	30 May 2023
Primary completion	30 August 2023
Estimated completion	30 August 2023
Sites	1 location across United Kingdom

Drugs / interventions tested

• Simulated exercises
• Mental Visualisation

Conditions studied

• Cognitive Deficit in Attention — all drugs for Cognitive Deficit in Attention →
• Musculoskeletal Strain — all drugs for Musculoskeletal Strain →
• Fatigue — all drugs for Fatigue →
• Surgery — all drugs for Surgery →

Sponsor

Lancaster University

Who can join

Adults 18 to 65, any sex, with Cognitive Deficit in Attention or Musculoskeletal Strain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.