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

NCT07589582 | Active Not Recruiting

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

Brief Summary

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.

Conditions

Anterior Cruciate Ligament Rupture; Active Noise Cancelling; Operation Time

Keywords

Anterior Cruciate Ligament Reconstruction; Operation Time

Outcome Measures

Primary Outcomes (1)

• Operation Time

  Reduce to operation time up to 12 minutes

  Intraoperative period

Secondary Outcomes (2)

• Taskload Index

  Intraoperative period

• Number of Repeated Commands

  Intraoperative period

Study Arms (2)

Active Noise Cancelling Group

EXPERIMENTAL

surgeon, assistant, and scrub nurse using ANC headphones with a closed-loop communication system

Behavioral: Active Noise Cancelling Close-Loop Communication

Control Group

EXPERIMENTAL

standard operating room conditions without headphones

Behavioral: Conventional Communication

Interventions

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.

Active Noise Cancelling Group

Conventional Communication BEHAVIORAL

Standard operating room conditions without headphones

Control Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Previous ACL reconstruction

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, 34752, 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

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Orthopaedic Surgery Resident, Research Fellow

Model Details: This is a prospective, randomized, parallel-group study comparing the using of ANC headphones combined with a closed-loop communication system with conventional communication during ACL reconstruction.

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: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)