Preoperative Anxiety and Music Therapy

Anxiety State Clinical Trial

Official title:

Anxiety, Preoperative Stress and Music Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171753
• Other study ID #: 5/CE/2016
• Status: Completed
• Phase: N/A
• First received: May 24, 2017
• Last updated: September 15, 2017
• Start date: February 15, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2017
• Source: University of Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety State

Intervention

Diagnostic Test:
• questionnaire
questionnarie will be performed before the application of headphone and after their removal.
• 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
• cardiac monitoring
the cardiac monitoring will be performed through study period
• 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
• No sound
No sound through an individual headset for 30 min

Locations

Country	Name	City	State
Italy	Ospedali Riuniti	Foggia	FG

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac monitoring	cardiac variability	through study period (to 15 min before the application of headphones until 15 minutes after their removal
Secondary	questionnaire	anxiety questionnarie	questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones)
Secondary	laboratory test	enzyme dosage	enzyme level change early after the application of headphones from baseline (early before the application of headphones)