Preoperative Anxiety and Music Therapy

Not Applicable

Completed

• Conditions: Anxiety State
• Interventions: Diagnostic Test: questionnaire; Diagnostic Test: laboratory test; Diagnostic Test: cardiac monitoring; Diagnostic Test: skin resistance; Device: Music listening; Device: No sound

• Registration Number: NCT03171753
• Lead Sponsor: University of Foggia

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.

Study Timeline

• Study Start: 2016-02-15
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-28
• Study First Posted: 2017-05-31
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy	Music listening	Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
Music therapy	questionnaire	Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
Control	laboratory test	patients wear headphones for 30 minuts without any sound
Music therapy	skin resistance	Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
Music therapy	laboratory test	Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
Music therapy	cardiac monitoring	Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
Control	No sound	patients wear headphones for 30 minuts without any sound
Control	cardiac monitoring	patients wear headphones for 30 minuts without any sound
Control	skin resistance	patients wear headphones for 30 minuts without any sound
Control	questionnaire	patients wear headphones for 30 minuts without any sound

Primary Outcome Measures

Name	Time	Method
cardiac monitoring	through study period (to 15 min before the application of headphones until 15 minutes after their removal	cardiac variability

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedali Riuniti; 🇮🇹 Foggia, FG, Italy