Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction (ANC-ACL-2026)
Effect of Active Noise-Cancelling Headphones With Closed-Loop Communication on Operative Efficiency During Arthroscopic Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Operating room noise represents a potential source of distraction and may interfere with effective communication, concentration, coordination, and surgical workflow. Active noise-cancelling headphones can reduce perceived background auditory stimuli; however, conventional noise-cancelling devices may also interfere with communication when used without a dedicated communication system.
This prospective, single-center, randomized controlled trial evaluates whether active noise-cancelling headphones integrated with a closed-loop communication system improve operative efficiency and intraoperative workflow during arthroscopic anterior cruciate ligament reconstruction.
Patients undergoing primary arthroscopic ACL reconstruction for isolated ACL rupture are randomized in a 1:1 ratio to an intervention group or a control group.
In the intervention group, the surgeon, first assistant, and scrub nurse use active noise-cancelling headphones connected through a closed-loop communication system throughout the surgical procedure. This system is designed to reduce perceived background auditory distractions while maintaining continuous verbal communication among the core surgical team. The anesthesia team does not use headphones and maintains awareness of monitor alarms, ventilator alarms, and operating room announcements. When required, communication between the anesthesia and surgical teams occurs using standard verbal communication.
In the control group, arthroscopic ACL reconstruction is performed under standard operating room conditions without active noise-cancelling headphones or an additional closed-loop communication system.
All procedures are performed using a standardized single-bundle hamstring autograft ACL reconstruction technique, standardized instrumentation, fixation systems, arthroscopic equipment, and operating room setup.
The primary objective is to evaluate the effect of ANC-assisted closed-loop communication on operative time. Secondary objectives include assessment of objective communication and workflow parameters, including command acknowledgment time, instrument handover time, and repeated verbal requests.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye), 340000
- Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 50 years
- Primary arthroscopic anterior cruciate ligament reconstruction
- Isolated ACL rupture confirmed by clinical examination and magnetic resonance imaging
- Ability to provide written informed consent
Exclusion Criteria:
- Concomitant meniscal injury
- Multiligament knee injury
- Previous ipsilateral knee surgery
- Concomitant fracture
- Concomitant cartilage restoration procedure
- Concomitant osteotomy
- Revision ACL reconstruction
- American Society of Anesthesiologists physical status greater than III
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ANC With Closed-Loop Communication
Participants undergo arthroscopic ACL reconstruction while the surgeon, first assistant, and scrub nurse use active noise-cancelling headphones connected through a closed-loop communication system.
The system allows continuous verbal communication among the core surgical team while reducing perceived background auditory distractions.
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Active noise-cancelling headphones connected through a closed-loop communication system are used by the surgeon, first assistant, and scrub nurse throughout arthroscopic ACL reconstruction.
The system is intended to reduce perceived background auditory distractions while maintaining continuous verbal communication among the core surgical team.
|
|
Active Comparator: Standard Operating Room Communication
Participants undergo the same standardized arthroscopic anterior cruciate ligament reconstruction under routine operating room conditions.
The surgeon, first assistant, and scrub nurse communicate using standard verbal communication without active noise-cancelling headphones or a dedicated closed-loop communication system.
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The surgical team performs arthroscopic ACL reconstruction under routine operating room conditions and communicates using standard verbal communication without active noise-cancelling headphones or a dedicated closed-loop communication system.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operation Time
Time Frame: Intraoperative, from skin incision to completion ofskin closure
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Operative time is defined as the elapsed time from skin incision to completion of skin closure and is measured in minutes.
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Intraoperative, from skin incision to completion ofskin closure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Command Acknowledgment Time
Time Frame: Intraoperative, during predefined standardized instrument-request events
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Command acknowledgment time is defined as the interval between the surgeon's verbal request and the first verbal acknowledgment by the first assistant or scrub nurse.
Measurements are obtained from video recordings of predefined standardized intraoperative communication events.
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Intraoperative, during predefined standardized instrument-request events
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Instrument Handover Time
Time Frame: Intraoperative, during predefined standardized instrument-request events
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Instrument handover time is defined as the interval between the surgeon's verbal request for an instrument and physical delivery of the requested instrument.
Measurements are obtained from video recordings of predefined standardized intraoperative instrument-request events.
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Intraoperative, during predefined standardized instrument-request events
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|
Repeated Verbal Requests
Time Frame: Intraoperative, during the surgical procedure
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A repeated verbal request is defined as any verbal request repeated because of an absent, delayed, or inadequate response.
The number of repeated requests is determined using video recordings of predefined standardized intraoperative communication events.
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Intraoperative, during the surgical procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: ONUR GULTEKIN, MD, FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL
Publications and helpful links
General Publications
- Oomens P, Fu VX, Kleinrensink VEE, Kleinrensink GJ, Jeekel J. The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study. World J Surg. 2020 Aug;44(8):2614-2619. doi: 10.1007/s00268-020-05523-0.
- Fancourt D, Burton TM, Williamon A. The razor's edge: Australian rock music impairs men's performance when pretending to be a surgeon. Med J Aust. 2016 Dec 12;205(11):515-518. doi: 10.5694/mja16.01045.
- Wu T, Qi H, Hui K, Hu Y, Xu M, Zhou J, Duan M. Effect of noise isolation with noise-cancelling earmuffs during laparoscopic surgery on acute postoperative pain: a clinical randomised controlled trial. BMC Anesthesiol. 2025 Oct 14;25(1):498. doi: 10.1186/s12871-025-03369-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANC-ACL-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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