Preoperative Anxiety and Music Therapy

Anxiety, Preoperative Stress and Music Therapy

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.

Study Overview

• Status: Completed
• Conditions: Anxiety State
• Intervention / Treatment: Diagnostic test: questionnaire; Diagnostic test: laboratory test; Diagnostic test: cardiac monitoring; Diagnostic test: skin resistance; Device: Music listening; Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • FG
    • Foggia, FG, Italy, 70100
      • Ospedali Riuniti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Music therapy; Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia	Diagnostic test: questionnaire; questionnarie will be performed before the application of headphone and after their removal.; Diagnostic test: 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; Diagnostic test: cardiac monitoring; the cardiac monitoring will be performed through study period; Diagnostic test: skin resistance; the skin resistance monitoring will be performed through study period; Device: Music listening; Listening prerecorded music through an individual headset for 30 min
ACTIVE_COMPARATOR: Control; patients wear headphones for 30 minuts without any sound	Diagnostic test: questionnaire; questionnarie will be performed before the application of headphone and after their removal.; Diagnostic test: 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; Diagnostic test: cardiac monitoring; the cardiac monitoring will be performed through study period; Diagnostic test: skin resistance; the skin resistance monitoring will be performed through study period; Device: No sound; No sound through an individual headset for 30 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cardiac monitoring	cardiac variability	through study period (to 15 min before the application of headphones until 15 minutes after their removal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire	anxiety questionnarie	questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones)
laboratory test	enzyme dosage	enzyme level change early after the application of headphones from baseline (early before the application of headphones)

Collaborators and Investigators

• Sponsor: University of Foggia

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2016
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 28, 2017
• First Posted (ACTUAL): May 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 5/CE/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED