Preoperative Anxiety and Music Therapy

Study Overview
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Brief Summary
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Music can reduce anxiety in adult patients awaiting surgical interventions. The study was designed to test the difference in cardiac parameters, anxiety questionnaire, laboratory enzymes, skin resitance between surgical patients listening music vs no sound.

Detailed Description
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Patients undergoing elective surgical intervention will be allocated in two groups: Group M will listen prerecorded music through an individual headset for 30 min before the induction of anesthesia; Group C will listen no sound through an individual headset for 30 min before the induction of anesthesia The degree of stress and anxiety the patients will be assessed using questionnaire. Laboratory enzymes will be measured. Heart rate, non invasive arterial pressure, pulse oximetry,skin resistance will be recorded. All the patients will receive continuous ECG holter recording . To assess the effect of music therapy on the degree of autonomic modulation, HRV will be analyzed with traditional time and frequency measures.

Official Title
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Anxiety, Preoperative Stress and Music Therapy

Conditions
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Anxiety State

Intervention / Treatment
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* Diagnostic Test: questionnaire
* Diagnostic Test: laboratory test
* Diagnostic Test: cardiac monitoring
* Diagnostic Test: skin resistance
* Device: Music listening
* Device: No sound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgical patients >18 years old, after obtaining informed consent Exclusion Criteria: patients with hearing impairment, any known psychiatric or memory disorder thyroid disease. atrial fibrillation pace-maker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music therapy<br>Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia | Diagnostic Test: questionnaire<br>* questionnarie will be performed before the application of headphone and after their removal.<br>Diagnostic Test: laboratory test<br>* laboratory test will be collected before the application of headphone and after their removal. the cardiac monitoring will be performed during the all study period<br>Diagnostic Test: cardiac monitoring<br>* the cardiac monitoring will be performed through study period<br>Diagnostic Test: skin resistance<br>* the skin resistance monitoring will be performed through study period<br>Device: Music listening<br>* Listening prerecorded music through an individual headset for 30 min<br>|
| Active Comparator: Control<br>patients wear headphones for 30 minuts without any sound | Diagnostic Test: questionnaire<br>* questionnarie will be performed before the application of headphone and after their removal.<br>Diagnostic Test: laboratory test<br>* laboratory test will be collected before the application of headphone and after their removal. the cardiac monitoring will be performed during the all study period<br>Diagnostic Test: cardiac monitoring<br>* the cardiac monitoring will be performed through study period<br>Diagnostic Test: skin resistance<br>* the skin resistance monitoring will be performed through study period<br>Device: No sound<br>* No sound through an individual headset for 30 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac monitoring | cardiac variability | through study period (to 15 min before the application of headphones until 15 minutes after their removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| questionnaire | anxiety questionnarie | questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones) | 
| laboratory test | enzyme dosage | enzyme level change early after the application of headphones from baseline (early before the application of headphones) |