Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees

NCT ID: NCT07089485

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-25

Study Completion Date

2026-09-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Surgical Procedures Noise Hearing Disorder Mental Workload

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This prospective interventional study will evaluate the impact of different noise levels in the operating room on surgeons' performance in simulation.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

effects of sound

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric MARCHAL, Pr.

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Nour Mammari Halabi, PhD.

Role: STUDY_CHAIR

Institut de Cancérologie de Lorraine

Central Contacts

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Jean-Louis JL MERLIN, PU.

Role: CONTACT

+33383598307 ext. 8307

Lydie LEMOINE

Role: CONTACT

03 83 59 86 89

References

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Roche TR, Said S, Braun J, Maas EJC, Machado C, Grande B, Kolbe M, Spahn DR, Nothiger CB, Tscholl DW. Avatar-based patient monitoring in critical anaesthesia events: a randomised high-fidelity simulation study. Br J Anaesth. 2021 May;126(5):1046-1054. doi: 10.1016/j.bja.2021.01.015. Epub 2021 Apr 8.

Reference Type BACKGROUND
PMID: 33879327 (View on PubMed)

Torabizadeh C, Yousefinya A, Zand F, Rakhshan M, Fararooei M. A nurses' alarm fatigue questionnaire: development and psychometric properties. J Clin Monit Comput. 2017 Dec;31(6):1305-1312. doi: 10.1007/s10877-016-9958-x. Epub 2016 Nov 15.

Reference Type BACKGROUND
PMID: 27848141 (View on PubMed)

Way TJ, Long A, Weihing J, Ritchie R, Jones R, Bush M, Shinn JB. Effect of noise on auditory processing in the operating room. J Am Coll Surg. 2013 May;216(5):933-8. doi: 10.1016/j.jamcollsurg.2012.12.048. Epub 2013 Mar 18.

Reference Type BACKGROUND
PMID: 23518255 (View on PubMed)

Whitham MD, Casali JG, Smith GK, Allihien AL, Wright BW, Barter SM, Urban AR, Dudley DJ, Fuller RR. Noise in cesarean deliveries: a comprehensive analysis of noise environments in the Labor and Delivery operating room and evaluation of a visual alarm noise abatement program. Am J Obstet Gynecol MFM. 2023 May;5(5):100887. doi: 10.1016/j.ajogmf.2023.100887. Epub 2023 Feb 11.

Reference Type BACKGROUND
PMID: 36781121 (View on PubMed)

Schmid F, Goepfert MS, Kuhnt D, Eichhorn V, Diedrichs S, Reichenspurner H, Goetz AE, Reuter DA. The wolf is crying in the operating room: patient monitor and anesthesia workstation alarming patterns during cardiac surgery. Anesth Analg. 2011 Jan;112(1):78-83. doi: 10.1213/ANE.0b013e3181fcc504. Epub 2010 Oct 21.

Reference Type BACKGROUND
PMID: 20966440 (View on PubMed)

Katz JD. Noise in the operating room. Anesthesiology. 2014 Oct;121(4):894-8. doi: 10.1097/ALN.0000000000000319. No abstract available.

Reference Type BACKGROUND
PMID: 24878496 (View on PubMed)

Lamotte AS, Essadek A, Shadili G, Perez JM, Raft J. The Impact of Classroom Chatter Noise on Comprehension: A Systematic Review. Percept Mot Skills. 2021 Jun;128(3):1275-1291. doi: 10.1177/00315125211005935. Epub 2021 Mar 27.

Reference Type BACKGROUND
PMID: 33775178 (View on PubMed)

Fu VX, Oomens P, Sneiders D, van den Berg SAA, Feelders RA, Wijnhoven BPL, Jeekel J. The Effect of Perioperative Music on the Stress Response to Surgery: A Meta-analysis. J Surg Res. 2019 Dec;244:444-455. doi: 10.1016/j.jss.2019.06.052. Epub 2019 Jul 18.

Reference Type BACKGROUND
PMID: 31326711 (View on PubMed)

El Boghdady M, Ewalds-Kvist BM. The influence of music on the surgical task performance: A systematic review. Int J Surg. 2020 Jan;73:101-112. doi: 10.1016/j.ijsu.2019.11.012. Epub 2019 Nov 22.

Reference Type BACKGROUND
PMID: 31760139 (View on PubMed)

Oomens P, Fu VX, Kleinrensink GJ, Jeekel J. The effect of music on simulated surgical performance: a systematic review. Surg Endosc. 2019 Sep;33(9):2774-2784. doi: 10.1007/s00464-019-06868-x. Epub 2019 May 28.

Reference Type BACKGROUND
PMID: 31140001 (View on PubMed)

Other Identifiers

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2025-A01256-43

Identifier Type: -

Identifier Source: org_study_id

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