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

NCT06729294 | Recruiting

• 1 other identifier: EBBMPDKASAAPC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

binaural beat music; anxiety; pain; cortisol

Outcome Measures

Primary Outcomes (3)

• State Anxiety Inventory

  It is the State Anxiety Inventory Form that will be used for the subjective evaluation of patients' anxietyThe State Anxiety Inventory Form is a highly sensitive tool for assessing sudden changes in emotional reactions.

  Through study completion, an average of 2 months

• Visual Analog Scale

  The Visual Comparison Scale, which will be used to evaluate the level of pain and patient satisfaction with knee arthroplasty, consists of a 10 cm long horizontal line.

  Through study completion, an average of 2 months

• Cortisol level

  Anxiety increases cortisol secretion via the autonomic nervous system, causing an increase in cortisol levels. In this study, blood cortisol levels will be evaluated as objective data of anxiety.Cortisol levels gradually decrease throughout the day, exhibiting a 24-hour circadian rhythm. Cortisol levels are highest in the morning and lowest at midnight. To avoid being affected by this circadian shift, the first cases of the day will be included in the study.

  Through study completion, an average of 2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Binaural beat music is therapeutic music that provides auditory stimuli at different frequencies to each ear. However, the maximum sound levels of 60 dB help to relax and reduce stress. There are studies that show that a slower rhythm and a slower decibel music makes the heart beats compatible with the rhythm. Support from an audiologist will be sought to adjust the volume of the binaural beat music to 50 dB. Natural sounds such as birdsong, waterfalls, ocean, river and forest sounds will be added to the soothing components of the melodies, tones and rhythms embedded in the binaural beats and 60-minute music arrangements will be created in the computer program. The resulting binaural beat music will be loaded into the Goldplay GP-1001 brand Mp3 player and listened to using headphones.

Other: Binaural beat music recital

Control group

NO INTERVENTION

Routine interventions will be applied to the control group without listening to music.

Interventions

Binaural beat music recital OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are older than 18 years,
• Who have undergone unilateral knee arthroplasty under spinal anesthesia for the first time,
• Who can communicate verbally,
• Who are in the ASA 1-2-3 group,
• Who do not have a neurological or psychiatric diagnosis will be included in the study.
• Since cortisol levels will be measured in our study, the first cases of the day will be included in the study.

You may not qualify if:

• Patients who refused to participate in the study were those with hearing impairment due to age or disease,
• Those who had any contraindications for spinal anesthesia,
• Those who were transferred to intensive care after the procedure,
• Those who developed complications during and after the procedure,
• Those who underwent general anesthesia,
• Those whose type of anesthesia was changed during surgery.

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead

Study Sites (1)

Kayseri City Hospital

Kocasinan, Kayseri, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fadime Ertural

  Nuh Naci Yazgan Üniversity

  PRINCIPAL INVESTIGATOR

• Salime Mucuk

  Erciyes Üniversty

  STUDY DIRECTOR

• Yeliz Sürme

  Erciyes Üniversty

  STUDY CHAIR

• Gülden Küçükakça Çelik

  Hacı Bektaş Veli Üniversty

  STUDY CHAIR

Central Study Contacts

Fadime Ertural

CONTACT

+905535904409; fertural@nny.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: February 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)