Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-02-15
2017-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Music therapy
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
questionnaire
questionnarie will be performed before the application of headphone and after their removal.
laboratory 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
cardiac monitoring
the cardiac monitoring will be performed through study period
skin resistance
the skin resistance monitoring will be performed through study period
Music listening
Listening prerecorded music through an individual headset for 30 min
Control
patients wear headphones for 30 minuts without any sound
questionnaire
questionnarie will be performed before the application of headphone and after their removal.
laboratory 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
cardiac monitoring
the cardiac monitoring will be performed through study period
skin resistance
the skin resistance monitoring will be performed through study period
No sound
No sound through an individual headset for 30 min
Interventions
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questionnaire
questionnarie will be performed before the application of headphone and after their removal.
laboratory 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
cardiac monitoring
the cardiac monitoring will be performed through study period
skin resistance
the skin resistance monitoring will be performed through study period
Music listening
Listening prerecorded music through an individual headset for 30 min
No sound
No sound through an individual headset for 30 min
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* any known psychiatric or memory disorder
* thyroid disease.
* atrial fibrillation
* pace-maker
18 Years
ALL
No
Sponsors
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University of Foggia
OTHER
Responsible Party
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Cotoia Antonella
Aggregate Professor, PhD
Locations
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Ospedali Riuniti
Foggia, FG, Italy
Countries
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Other Identifiers
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5/CE/2016
Identifier Type: -
Identifier Source: org_study_id