Active Noise-Cancelling Headphones Reduce Operative Time and Improve Procedural Consistency in ACL Reconstruction l (ANC-ACL)

May 11, 2026 updated by: Muhammet Sivritas, Fatih Sultan Mehmet Training and Research Hospital

Active Noise-Cancelling Headphones and Closed-Loop Communication Reduce Operative Time and Improve Procedural Consistency in Anterior Cruciate Ligament Reconstruction: A Pilot Randomized Controlled Trial

High noise levels generated by arthroscopic equipment may impair intraoperative communication and increase cognitive workload, potentially affecting surgical efficiency. Active noise-cancelling (ANC) systems combined with closed-loop communication may enhance team interaction; however, their clinical impact remains unclear. Purpose of this study is To evaluate the effect of ANC headphones and a closed-loop communication system on operative time and intraoperative team performance during arthroscopic anterior cruciate ligament (ACL) reconstruction.

Study Overview

Detailed Description

This prospective, two-arm pilot randomized controlled trial included patients aged 18-50 years undergoing primary arthroscopic ACL reconstruction. Participants were randomized (1:1) into:

  • Control group: standard operating room conditions without headphones
  • ANC group: surgeon, assistant, and scrub nurse using ANC headphones with a closed-loop communication system

The anesthesia team did not use headphones to ensure continuous monitoring of patient safety.

The primary outcome was operative time (skin incision to closure). Secondary outcomes included communication quality, number of repeated or misunderstood commands, NASA-TLX workload scores, and intraoperative noise levels.

Study Type

Interventional

Enrollment (Estimated)

54

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 Locations

      • Istanbul, Turkey (Türkiye), 34752
        • Fatih Sultan Mehmet Training and Research Hospital

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who have undergone anterior cruciate ligament (ACL) reconstruction
  • Willingness to participate and provide informed consent

Exclusion Criteria:

  • Previous ACL reconstruction

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Noise Cancelling Group
surgeon, assistant, and scrub nurse using ANC headphones with a closed-loop communication system
To evaluate the effect of ANC headphones and a closed-loop communication system on operative time and intraoperative team performance during arthroscopic anterior cruciate ligament (ACL) reconstruction.
Experimental: Control Group
standard operating room conditions without headphones
Standard operating room conditions without headphones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operation Time
Time Frame: Intraoperative period
Reduce to operation time up to 12 minutes
Intraoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Taskload Index
Time Frame: Intraoperative period
Reduce NASA-TLX taskload index scores
Intraoperative period
Number of Repeated Commands
Time Frame: Intraoperative period
Reducing repetative commands
Intraoperative period

Collaborators and Investigators

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

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.

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 (Actual)

April 25, 2026

Primary Completion (Estimated)

October 5, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared.

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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