Effect of Music Listened During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuh Naci Yazgan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Binaural beat music recital
Other interventionBinaural 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 2 months2
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.
Time frame
Through study completion, an average of 2 months3
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.
Time frame
Through study completion, an average of 2 monthsSponsors and contacts
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Source ClinicalTrials.gov