Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees

NCT07089485 | Not Yet Recruiting

• 1 other identifier: 2025-A01256-43
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Surgical Procedures; Noise; Hearing Disorder; Mental Workload

Keywords

Noise/adverse effects; Cognition Disorders; Surgical procedures

Outcome Measures

Primary Outcomes (1)

• Impact of the optimal sound intensity level during a surgical procedure

  Assessment of heart and respiratory rate variability parameters

  From inclusion (baseline) to 6 months post-inclusion

Secondary Outcomes (2)

• Interference with the surgical procedure

  From inclusion (baseline) until the end of the surgical procedure

• Mental workload of the surgical trainee

  From inclusion (baseline) until the end of the surgical procedure

Study Arms (1)

surgical trainees group

OTHER

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

Interventions

effects of sound 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.

surgical trainees group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Related Publications (10)

• 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.

  PMID: 33879327 BACKGROUND

• 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.

  PMID: 27848141 BACKGROUND

• 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.

  PMID: 23518255 BACKGROUND

• 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.

  PMID: 36781121 BACKGROUND

• 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.

  PMID: 20966440 BACKGROUND

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

  PMID: 24878496 BACKGROUND

• 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.

  PMID: 33775178 BACKGROUND

• 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.

  PMID: 31326711 BACKGROUND

• 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.

  PMID: 31760139 BACKGROUND

• 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.

  PMID: 31140001 BACKGROUND

MeSH Terms

Conditions

Hearing Disorders; Cognition Disorders

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Frédéric MARCHAL, Pr.

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

• Nour Mammari Halabi, PhD.

  Institut de Cancérologie de Lorraine

  STUDY CHAIR

Central Study Contacts

Jean-Louis JL MERLIN, PU.

CONTACT

+33383598307; jl.merlin@nancy.unicancer.fr

Lydie LEMOINE

CONTACT

03 83 59 86 89; l.lemoine@nancy.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This prospective interventional study will evaluate the impact of different noise levels in the operating room on surgeons' performance in simulation.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 28, 2025
• Study Start: September 25, 2025
• Primary Completion: March 25, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share