Preoperative Anxiety and Music Therapy

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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