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Clinical Trials/NCT03171753
NCT03171753
Completed
Not Applicable

Anxiety, Preoperative Stress and Music Therapy

University of Foggia1 site in 1 country60 target enrollmentFebruary 15, 2016
ConditionsAnxiety State

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety State
Sponsor
University of Foggia
Enrollment
60
Locations
1
Primary Endpoint
cardiac monitoring
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2016
End Date
June 30, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Foggia
Responsible Party
Principal Investigator
Principal Investigator

Cotoia Antonella

Aggregate Professor, PhD

University of Foggia

Eligibility Criteria

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

Outcomes

Primary Outcomes

cardiac monitoring

Time Frame: through study period (to 15 min before the application of headphones until 15 minutes after their removal

cardiac variability

Secondary Outcomes

  • questionnaire(questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones))
  • laboratory test(enzyme level change early after the application of headphones from baseline (early before the application of headphones))

Study Sites (1)

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