- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07589582
Active Noise-Cancelling Headphones Reduce Operative Time and Improve Procedural Consistency in ACL Reconstruction l (ANC-ACL)
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
Study Overview
Status
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye), 34752
- 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:
- Patients who have undergone anterior cruciate ligament (ACL) reconstruction
- Willingness to participate and provide informed consent
Exclusion Criteria:
- Previous ACL reconstruction
Study Plan
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.
|
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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
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
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
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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