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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| music group | Active Comparator | 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. |
|
| operating room noise group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| music | Other | effect of music on anxiety scores |
| |
| operating room noise |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Sait Kavakli, M.D. | Antalya Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antalya Training and Research hospital | Antalya | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Other |
effect of operating room noise on anxiety 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 |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |