NCT05472103

Brief Summary

It is well known that surgery requires not only a mental diligence, but also a real physical stress due to the need to assume particular postures for many hours or to repeat specific maneuvers several times. To this peculiar condition of surgical specialities over the years has been added the development of a series of instruments and technologies ranging from the use of loopes, to laparoscopic and robotic surgery. From the studies reported in the literature, between 74% and 87% of surgeons report symptoms related to their work with consequent effects on the quality of life (sleep loss, inability to carry out their recreational activities, etc.). Similarly, a lack of knowledge of the principles of ergonomics to be applied during the performance of one's surgical activity emerged, which could improve musculoskeletal symptoms with a positive effect on the quality of life of surgeons and consequently hoping for an improvement in professional performance.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 21, 2022

Last Update Submit

July 21, 2022

Conditions

Keywords

Musculoskeletal Pain; ergonomics; surgery

Outcome Measures

Primary Outcomes (1)

  • rate of musculoskeletal symptoms

    one month

Secondary Outcomes (1)

  • quality of life

    one month

Study Arms (2)

treatment

EXPERIMENTAL

administration of Surgical ergonomics workshop

Behavioral: ergonomics surgical workshop

control

NO INTERVENTION

no intervention

Interventions

ergonomics surgical workshop

treatment

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young surgeons

You may not qualify if:

  • no consent to partecipate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Giuseppe Di Buono

Palermo, PA, 90144, Italy

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Surgery

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

August 10, 2022

Primary Completion

October 30, 2022

Study Completion

November 30, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations