Clinical Trials Directory

Trials / Completed

CompletedNCT03171753

Preoperative Anxiety and Music Therapy

Anxiety, Preoperative Stress and Music Therapy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
60 (actual)
Sponsor
University of Foggia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTquestionnairequestionnarie will be performed before the application of headphone and after their removal.
DIAGNOSTIC_TESTlaboratory testlaboratory 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 monitoringthe cardiac monitoring will be performed through study period
DIAGNOSTIC_TESTskin resistancethe skin resistance monitoring will be performed through study period
DEVICEMusic listeningListening prerecorded music through an individual headset for 30 min
DEVICENo soundNo sound through an individual headset for 30 min

Timeline

Start date
2016-02-15
Primary completion
2017-06-30
Completion
2017-06-30
First posted
2017-05-31
Last updated
2017-09-18

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT03171753. Inclusion in this directory is not an endorsement.