Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees (ASLEC02)

September 22, 2025 updated by: Institut de Cancérologie de Lorraine

Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees: A Randomized Pilot Simulation Study

Noise in hospital environments, particularly in operating rooms, poses challenges to both patient comfort and healthcare professionals' performance. Among the sources of noise, anesthesia monitoring alarms are essential for patient safety, yet no clear guidelines exist regarding their optimal sound level. Excessive alarm volume may increase distraction and cognitive load, especially for surgical trainees, potentially impairing their focus and performance during procedures. This randomized pilot interventional study aims to evaluate the impact of anesthesia alarm sound intensity on the mental workload of surgical trainees performing simulated surgeries. Participants will be randomly assigned to conditions with either an optimized alarm volume or a higher standard volume during simulated tasks. Cognitive load will be assessed using objective physiological measures such as heart rate variability and pupillometry, as well as subjective evaluations with tools like the NASA-TLX and SURG-TLX scales. The primary goal is to determine whether an optimized alarm sound level can reduce cognitive strain without compromising vigilance required for patient safety. Findings from this study are expected to provide evidence-based recommendations for auditory ergonomics in operating rooms, ultimately improving working conditions for surgical teams and enhancing both training and patient safety.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Noise pollution in hospital environments, particularly within operating rooms (ORs), is a growing concern. It can impact not only the comfort and well-being of patients but also the cognitive performance and concentration of healthcare professionals. Among the various sources of noise, auditory alarms used in anesthesia monitoring are critical for patient safety. However, despite their importance, there are currently no established guidelines or regulations defining the optimal volume at which these alarms should be set.

Previous studies have examined the effects of background noise and music on surgical performance, with some showing that certain types of music can reduce stress or improve focus. However, the specific impact of anesthesia alarm sounds especially when they are excessively loud or frequent remains poorly understood. These alarms may distract surgical teams, particularly trainees, and contribute to increased cognitive load, potentially impairing performance during surgical procedures.

Cognitive load refers to the amount of mental effort being used in working memory. In the operating room, excessive cognitive load can hinder performance, decision-making, and reaction time, particularly in complex or high-pressure situations. Understanding how to manage and optimize environmental factors that influence mental workload is therefore essential, especially for surgical trainees still developing their skills.

This randomized pilot interventional study aims to investigate the effect of anesthesia alarm sound intensity on the mental workload of novice surgeons performing simulated procedures. By focusing on surgical trainees working on a high-fidelity simulator, we aim to create a controlled yet realistic environment to assess the cognitive impact of varying alarm volumes.

The study will compare two conditions: an optimized alarm sound level and a higher-level alarm sound (above ambient noise). Participants will be randomly assigned to one of these conditions during their simulated surgical tasks. The primary outcome is the cognitive load experienced by the trainees under each condition.

To comprehensively assess cognitive load, both objective and subjective tools will be used. Objective measures will include heart rate variability (HRV) and pupillometry two physiological indicators of stress and cognitive effort. Subjective cognitive load will be measured using validated scales such as the NASA Task Load Index (NASA-TLX) or its surgical adaptation, the SURG-TLX. These tools evaluate dimensions such as mental demand, effort, frustration, and performance.

By combining physiological data with subjective reports, the study seeks to capture a multidimensional understanding of how alarm noise affects surgical trainees. The ultimate goal is to determine whether reducing the intensity of auditory alarms while maintaining their effectiveness can minimize unnecessary cognitive strain and distraction during procedures.

The findings of this study are expected to inform future recommendations regarding auditory ergonomics in operating rooms. Establishing evidence-based guidelines for alarm sound levels could contribute to a safer, less stressful working environment for surgical teams. This is particularly important in the training context, where the balance between realism and cognitive manageability is crucial for learning and performance.

In conclusion, this pilot study addresses a critical and underexplored aspect of the surgical environment: the cognitive impact of anesthesia alarm noise. By evaluating its effects on novice surgeons, the research aims to promote better alarm management strategies, improve working conditions, and ultimately enhance both patient safety and surgical education.

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Surgical residents or experienced surgeons;
  • Surgeons with normal hearing;
  • Surgeons capable of performing surgical sutures (regardless of skill level);
  • Surgeons able and willing to follow all study procedures according to the protocol;
  • Surgeons who have understood, signed, and dated the informed consent form provided on the day of enrollment.

Exclusion Criteria:

  • Surgeons undergoing beta-blocker treatment;
  • Surgeons with known cardiac pathology;
  • Surgeons who do not consent to participate in the study;
  • Surgeons with known hearing problems;
  • Surgeons who fail the hearing test;
  • Surgeons who worked on-call or night shifts during the night before the evaluation day.
  • Surgical trainees at the Lorraine Cancer Institute.
  • Adults under legal protection (guardianship, curatorship, or legal supervision);Persons deprived of liberty;Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: surgical trainees group
The study group consists of surgical trainees with limited experience in simulated surgery. They will perform multiple 15-minute surgical sequences in a controlled environment, where anesthesia alarm sound levels will vary between 64 and 75 dB(A). These sound levels will be randomized across the sequences to assess the impact of noise on their mental workload, concentration, and surgical performance.
Other: effects of sound
The surgical trainees will perform four 15-minute surgical sequences in a controlled environment, with varying sound levels (64, 67, 73, and 75 dB(A)) randomized across the sequences to assess the surgeons' responses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the optimal sound intensity level during a surgical procedure
Time Frame: From inclusion (baseline) to 6 months post-inclusion
Assessment of heart and respiratory rate variability parameters
From inclusion (baseline) to 6 months post-inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interference with the surgical procedure
Time Frame: From inclusion (baseline) until the end of the surgical procedure
Measurement using the SURG-TLX (Surgical Task Load Index) questionnaire
From inclusion (baseline) until the end of the surgical procedure
Mental workload of the surgical trainee
Time Frame: From inclusion (baseline) until the end of the surgical procedure
Measurement using the SURG-TLX scale.
From inclusion (baseline) until the end of the surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Study Chair: Nour Mammari Halabi, PhD., Institut de Cancérologie de Lorraine
  • Principal Investigator: Frédéric MARCHAL, Pr., Institut de Cancérologie de Lorraine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2025

Primary Completion (Estimated)

March 25, 2026

Study Completion (Estimated)

September 26, 2026

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 21, 2025

First Posted (Actual)

July 28, 2025

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A01256-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At this time, the individual participant data (IPD) will not be shared due to concerns regarding participant privacy and confidentiality, as well as institutional policies restricting data sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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