Back to resultsPreoperative Anxiety and Music Therapy
Primary Purpose
Anxiety State
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
questionnaire
laboratory test
cardiac monitoring
skin resistance
Music listening
No sound
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety State
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
Sites / Locations
- Ospedali Riuniti
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Music therapy
Control
Arm Description
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
patients wear headphones for 30 minuts without any sound
Outcomes
Primary Outcome Measures
cardiac monitoring
cardiac variability
Secondary Outcome Measures
questionnaire
anxiety questionnarie
laboratory test
enzyme dosage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03171753
Brief Title
Preoperative Anxiety and Music Therapy
Official Title
Anxiety, Preoperative Stress and Music Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Foggia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
Listening prerecorded music through an individual headset for 30 min in before the induction of anesthesia
Arm Title
Control
Arm Type
Active Comparator
Arm Description
patients wear headphones for 30 minuts without any sound
Intervention Type
Diagnostic Test
Intervention Name(s)
questionnaire
Intervention Description
questionnarie will be performed before the application of headphone and after their removal.
Intervention Type
Diagnostic Test
Intervention Name(s)
laboratory test
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
cardiac monitoring
Intervention Description
the cardiac monitoring will be performed through study period
Intervention Type
Diagnostic Test
Intervention Name(s)
skin resistance
Intervention Description
the skin resistance monitoring will be performed through study period
Intervention Type
Device
Intervention Name(s)
Music listening
Intervention Description
Listening prerecorded music through an individual headset for 30 min
Intervention Type
Device
Intervention Name(s)
No sound
Intervention Description
No sound through an individual headset for 30 min
Primary Outcome Measure Information:
Title
cardiac monitoring
Description
cardiac variability
Time Frame
through study period (to 15 min before the application of headphones until 15 minutes after their removal
Secondary Outcome Measure Information:
Title
questionnaire
Description
anxiety questionnarie
Time Frame
questionnaire score change 15 min after the removal of headphones from baseline ( early before the application of headphones)
Title
laboratory test
Description
enzyme dosage
Time Frame
enzyme level change early after the application of headphones from baseline (early before the application of headphones)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ospedali Riuniti
City
Foggia
State/Province
FG
ZIP/Postal Code
70100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Preoperative Anxiety and Music Therapy
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