Effect of Music Listened During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels

NCT06729294 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-20

No results posted yet for this study

Summary

The aim of this study is to examine the effects of binaural beat music played during spinal anesthesia knee arthroplasty on anxiety, pain and cortisol levels. The study was planned as a randomized controlled experimental design study. The hypotheses of the study are as follows;

* Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on anxiety.
* Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on anxiety.
* Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on pain levels.
* Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on pain levels.
* Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on cortisol levels.
* Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on cortisol levels.

A sample group will be formed with 20 patients in the intervention group and 20 patients in the control group. Binaural beat music will be played in the intervention group during the surgical procedure, and routine interventions will be applied to the control group.

Data collection in the intervention group is as follows;

* Patients will be interviewed in the surgery clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled out.
* The 1st measurement of hemodynamic data will be recorded immediately before the surgery
* A musical concert will be started as soon as the surgery begins
* The musical concert will end when the surgery ends
* The 2nd measurement will be recorded immediately after the surgery ends
* In the post-surgery collection unit, the State Anxiety Inventory Form and the Visual Comparison Scale will be used, and a blood sample will be taken to determine cortisol values.

The control group data collection methods are as follows;

* Patients will be interviewed in the surgical clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled in
* The first measurement of hemodynamic data will be recorded immediately before the surgical procedure
* The second measurement will be recorded immediately after the surgical procedure is completed
* Blood samples will be taken in the post-surgical recovery unit to determine the State Anxiety Inventory Form, Visual Comparison Scale and cortisol values.

Conditions

  • Spinal Anesthesia
  • Knee Arthroplasty

Interventions

OTHER

Binaural beat music recital

Binaural beats music is therapeutic music that provides auditory stimuli at different frequencies to each ear. However, the maximum sound levels are 60 dB, which helps to relax and reduce stress.

Sponsors & Collaborators

  • Nuh Naci Yazgan University

    lead OTHER

Principal Investigators

  • Fadime Ertural · Nuh Naci Yazgan Üniversity

  • Salime Mucuk · Erciyes Üniversty

  • Yeliz Sürme · Erciyes Üniversty

  • Gülden Küçükakça Çelik · Hacı Bektaş Veli Üniversty

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-12-31
Completion
2026-02-28

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06729294 on ClinicalTrials.gov