Active Noise-Cancelling Headphones With Closed-Loop Communication During Arthroscopic ACL Reconstruction

NCT07589582 | Active Not Recruiting

• 1 other identifier: ANC-ACL-26
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Operating room noise may interfere with communication, concentration, and surgical workflow. Active noise-cancelling (ANC) headphones can reduce background auditory distractions; however, their potential benefit during surgery may depend on maintaining effective communication among surgical team members. This prospective randomized controlled trial evaluates the effect of ANC headphones integrated with a closed-loop communication system on operative efficiency and intraoperative workflow during arthroscopic anterior cruciate ligament (ACL) reconstruction. Participants undergoing primary arthroscopic ACL reconstruction are randomized to either an ANC group or a control group. In the ANC group, the surgeon, first assistant, and scrub nurse use ANC headphones connected through a closed-loop communication system during surgery. The control group undergoes surgery under standard operating room conditions. The primary outcome is operative time from skin incision to skin closure. Secondary outcomes include command acknowledgment time, instrument handover time, and repeated verbal requests assessed using objective video-based workflow analysis.

Conditions

Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament (ACL) Tear; Anterior Cruciate Ligament Injury

Keywords

Anterior Cruciate Ligament Reconstruction; ACL Reconstruction; Active Noise Cancellation; Noise-Cancelling Headphones; Operating Room Noise; Operating Room Communication; Closed-Loop Communication; Surgical Workflow; Operative Efficiency; Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Operation Time

  Operative time is defined as the elapsed time from skin incision to completion of skin closure and is measured in minutes.

  Intraoperative, from skin incision to completion ofskin closure

Secondary Outcomes (3)

• Command Acknowledgment Time

  Intraoperative, during predefined standardized instrument-request events

• Instrument Handover Time

  Intraoperative, during predefined standardized instrument-request events

• Repeated Verbal Requests

  Intraoperative, during the surgical procedure

Study Arms (2)

ANC With Closed-Loop Communication

EXPERIMENTAL

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.

Device: Active Noise-Cancelling Headphones With Closed-Loop Communication

Standard Operating Room Communication

ACTIVE COMPARATOR

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.

Other: Standard Operating Room Communication

Interventions

Active Noise-Cancelling Headphones With Closed-Loop Communication DEVICE

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.

ANC With Closed-Loop Communication

Standard Operating Room Communication OTHER

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.

Standard Operating Room Communication

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Istanbul Provincial Health Directorate Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 340000, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32333159 BACKGROUND

• 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.

  PMID: 27927145 BACKGROUND

• 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.

  PMID: 41087929 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Lacerations; Teach-Back Communication

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Communication; Behavior

Study Officials

• ONUR GULTEKIN, MD

  FATIH SULTAN MEHMET RESEARCH AND TRANING HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not feasible due to the visible nature of the surgical incision during postoperative assessments. Therefore, surgeons, participants, and outcome assessors were not blinded to group allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Orthopaedic Surgery Resident, Research Fellow

Model Details: Participants were randomized in a 1:1 ratio to either active noise-cancelling headphones with closed-loop communication or standard operating room conditions.

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)