Effect of Music During Carotid Endarterectomy

Antalya Training and Research Hospital64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Anxiety State

Interventions

musicOTHER

effect of music on anxiety scores

operating room noiseOTHER

effect of operating room noise on anxiety scores

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Antalya Training and Research hospital

Antalya, Turkey (Türkiye)

Outcomes

Primary Outcomes

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"

Time frame: 60 minutes

Secondary Outcomes

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"

Time frame: 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)

Time frame: 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.

Time frame: 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.

Time frame: 20 minutes

Differences in pain scores

assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain))

Time frame: 10 minutes

Changes in mean arterial pressure

Data from ClinicalTrials.gov

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