Anxiety State
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTquestionnaire
questionnarie will be performed before the application of headphone and after their removal.
DIAGNOSTIC_TESTlaboratory test
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
DIAGNOSTIC_TESTcardiac monitoring
the cardiac monitoring will be performed through study period
DIAGNOSTIC_TESTskin resistance
the skin resistance monitoring will be performed through study period
DEVICEMusic listening
Listening prerecorded music through an individual headset for 30 min
DEVICENo sound
No sound through an individual headset for 30 min
Sponsors
University of Foggia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiac monitoring | through study period (to 15 min before the application of headphones until 15 minutes after their removal | cardiac variability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| questionnaire | questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones) | anxiety questionnarie |
| laboratory test | enzyme level change early after the application of headphones from baseline (early before the application of headphones) | enzyme dosage |
Countries
Italy
Outcome results
None listed