Effect of Music During Carotid Endarterectomy

Study Overview
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Brief Summary
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The purpose of this study is to test the hypothesis that music listening during carotid endarterectomy administered the cervical plexus block will cause less anxiety, less pain, and greater patient satisfaction.

Detailed Description
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Patients who decided to participate in the study were randomized by means of a computer-generated randomization order into 2 groups: Music Group (Group M) and Operating Room (OR) Noise Group (Group O). Randomization was independently carried out in both centers. Preoperative and postoperative State Trait Anxiety Inventory (STAI) scores, intraoperative STAI responses, preoperative and postoperative numerical rating scale scores for anxiety, pain scores and hemodynamic parameters were recorded.

Official Title
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Effect of Music on Patient's Anxiety, Satisfaction and Pain During Carotid Endarterectomy: Multicenter Prospective Randomized Controlled Trial

Conditions
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Anxiety State

Intervention / Treatment
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* Other: music
* Other: operating room noise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing carotid endarterectomy using cervical plexus block American Society of Anesthesiologists class 2 to 3 Ability to consent Exclusion Criteria: inability to communicate not understand the aim and objectives of the study not provide informed written consent contraindications for the block (local infection, coagulation disorders) hypersensitivity to the local anesthetics refusal of regional anesthesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: music group<br>in music group, patient was asked to choose one music genres from 5 different music genres according to his/her preference. Patient selected music was delivered by an iPhone 6 and Music app (Apple Inc., USA) through the iPhone's headphones. | Other: music<br>* effect of music on anxiety scores<br>|
| Active Comparator: operating room noise group<br>in operating room noise group, operating room noise was delivered by an iPhone and Microphone App (Free version, Von Bruno). This application allows the iPhone to be used as a live microphone. | Other: operating room noise<br>* effect of operating room noise on anxiety scores<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed ) | Assessed every 5 minutes during the procedure. The question is are you relaxed and patient is asked to answer the question on a scale of very much, moderately, somewhat, or not at all | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in intraoperative State-Trait Anxiety Inventory Response (calm) | Assessed every 5 minutes during the procedure. The questions is are you calm and patient is asked to answer the question on a scale of very much, moderately, somewhat, or not at all | 60 minutes | 
| Differences in postoperative anxiety numerical rating scale scores | assessed 5 min after the procedure. Numeric Rating Scale (NRS): from 0 (no anxiety) to 10 (worst feeling of anxiety possible) | 10 minutes | 
| Differences in preoperative State-Trait Anxiety Inventory scores | assessed 1 day before surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety. | 20 minutes | 
| Differences in postoperative State-Trait Anxiety Inventory scores | assessed 1st day after surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety. | 20 minutes | 
| Differences in pain scores | assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain)) | 10 minutes | 
| Changes in mean arterial pressure | Assessed every 5 minutes during the procedure | 60 minutes | 
| Changes in heart rate | Assessed every 5 minutes during the procedure | 60 minutes |