Preoperative Anxiety and Music Therapy

University of Foggia

Status: Completed

Conditions: Anxiety State

Treatments: Device: Music listening; Diagnostic Test: skin resistance; Diagnostic Test: questionnaire; Diagnostic Test: cardiac monitoring; Diagnostic Test: laboratory test; Device: No sound

Study type: Interventional

Funder types: Other

Identifiers

NCT03171753

5/CE/2016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Music therapy

Experimental group

Description:

Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia

Treatment:

Diagnostic Test: laboratory test

Diagnostic Test: cardiac monitoring

Diagnostic Test: questionnaire

Diagnostic Test: skin resistance

Device: Music listening

Control

Active Comparator group

Description:

patients wear headphones for 30 minuts without any sound

Treatment:

Device: No sound

Diagnostic Test: laboratory test

Diagnostic Test: cardiac monitoring

Diagnostic Test: questionnaire

Diagnostic Test: skin resistance