Effect of Music During Carotid Endarterectomy
- Conditions
- Anxiety State
- Interventions
- Other: operating room noiseOther: music
- Registration Number
- NCT03457181
- Lead Sponsor
- Antalya Training and Research Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Patients undergoing carotid endarterectomy using cervical plexus block
- American Society of Anesthesiologists class 2 to 3
- Ability to consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description operating room noise group operating room noise 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. music group music 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.
- Primary Outcome Measures
Name Time Method Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed ) 60 minutes 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"
- Secondary Outcome Measures
Name Time Method Differences in postoperative State-Trait Anxiety Inventory scores 20 minutes assessed 1st day after surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.
Changes in mean arterial pressure 60 minutes Assessed every 5 minutes during the procedure
Differences in intraoperative State-Trait Anxiety Inventory Response (calm) 60 minutes 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"
Changes in heart rate 60 minutes Assessed every 5 minutes during the procedure
Differences in postoperative anxiety numerical rating scale scores 10 minutes assessed 5 min after the procedure. Numeric Rating Scale (NRS): from 0 (no anxiety) to 10 (worst feeling of anxiety possible)
Differences in preoperative State-Trait Anxiety Inventory scores 20 minutes assessed 1 day before surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.
Differences in pain scores 10 minutes assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain))
Trial Locations
- Locations (1)
Antalya Training and Research hospital
🇹🇷Antalya, Turkey