Anxiety State
Conditions
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.
Interventions
OTHERmusic
effect of music on anxiety scores
OTHERoperating room noise
effect of operating room noise on anxiety scores
Sponsors
Antalya Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 mean arterial pressure | 60 minutes | Assessed every 5 minutes during the procedure |
| Changes in heart rate | 60 minutes | Assessed every 5 minutes during the procedure |
| Differences in pain scores | 10 minutes | assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain)) |
Countries
Turkey (Türkiye)
Outcome results
None listed