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NCT Number: NCT07589582

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Active Noise Cancelling Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Operation Time Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Previous ACL reconstruction

Treatment and study plan

Active Noise Cancelling Close-Loop Communication

Behavioral

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.

conventional communication

Behavioral

Standard operating room conditions without headphones

Primary outcomes

  1. Operation Time

    Time frame: Intraoperative period

    Reduce to operation time up to 12 minutes

Secondary outcomes

  1. NASA Task Load Index (NASA-TLX)

    Time frame: Immediately after completion of the surgical procedure (intraoperative assessment).

    The NASA Task Load Index (NASA-TLX) will be used to assess the perceived workload of the operating surgeon during arthroscopic rotator cuff repair. The NASA-TLX is a validated multidimensional instrument that evaluates six domains of workload: mental demand, physical demand, temporal demand, performance, effort, and frustration. Each domain is rated on a scale from 0 to 100, with higher scores indicating greater perceived workload. An overall workload score will be calculated according to the standard NASA-TLX scoring method.

  2. Number of Repeated Commands

    Time frame: Intraoperative period

    Reducing repetative commands

Sponsors and collaborators

Lead sponsor

Fatih Sultan Mehmet Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: ANC-ACL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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