Actively Recruiting
Effect of Binaural Beat Music Played During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels
Led by Nuh Naci Yazgan University · Updated on 2025-08-20
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of binaural beat music played during spinal anesthesia knee arthroplasty on anxiety, pain, and cortisol levels. This randomized controlled experimental study aims to understand whether this music intervention can influence these factors, which are important because pain and anxiety can affect surgery outcomes and recovery. The study involves 40 patients divided into two groups: one receiving binaural beat music during surgery and one receiving routine care without music. In the intervention group, patients will listen to specially designed binaural beat music through headphones during the surgical procedure. This music, set at a maximum of 60 dB and combined with natural sounds like birdsong and waterfalls, is intended to relax and reduce stress. The control group will receive standard care without music. Binaural beat music will start when surgery begins and end when surgery ends. The study is double-blinded and randomized with two groups: intervention and control. Participants will be interviewed before surgery to collect baseline data and anxiety levels using the State Anxiety Inventory Form. Hemodynamic data will be recorded immediately before and after surgery. After surgery, anxiety, pain levels using the Visual Analog Scale, and cortisol levels via blood samples will be measured. Researchers will monitor these outcomes through study completion, averaging about two months. This study also includes safety monitoring and excludes patients who have contraindications for spinal anesthesia or complications during surgery.
CONDITIONS
Brief Title
Effect of Music Listened During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who are older than 18 years
- Patients undergoing their first unilateral knee arthroplasty under spinal anesthesia
- Patients who can communicate verbally
- Patients classified in the ASA 1, 2, or 3 group
- Patients without neurological or psychiatric diagnoses
- Patients scheduled as first cases of the day for cortisol measurement
You will not qualify if you...
- Patients who refuse to participate in the study
- Patients with hearing impairment due to age or disease
- Patients with contraindications for spinal anesthesia
- Patients transferred to intensive care after the procedure
- Patients who develop complications during or after the procedure
- Patients who undergo general anesthesia
- Patients whose anesthesia type changes during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgical procedure
Participants undergo knee arthroplasty under spinal anesthesia. During the surgery, participants in the intervention group listen to binaural beat music through headphones to reduce anxiety and stress caused by the operating room noise and the surgical procedure.
1 visit (in-person surgery day)
Duration - Up to 2 months after surgery
Participants are monitored for anxiety, pain, and cortisol levels after the surgery to assess the effects of the music intervention.
Follow-up visits as per study schedule
Trial Site Locations
Total: 1 location
1
Kayseri City Hospital
Kocasinan, Kayseri, Turkey (Türkiye)
Actively Recruiting
Research Team
F
Fadime Ertural
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here