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

NCT05884385 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-08-28

No results posted yet for this study

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.

Conditions

  • Cognitive Deficit in Attention
  • Musculoskeletal Strain
  • Fatigue
  • Surgery

Interventions

OTHER

Simulated exercises

as detailed in arm description

OTHER

Mental Visualisation

as detailed in arm description

Sponsors & Collaborators

  • East Lancashire Hospitals NHS Trust

    collaborator OTHER

  • Lancaster University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-30
Primary Completion
2023-08-30
Completion
2023-08-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05884385 on ClinicalTrials.gov