Effect of Music During Carotid Endarterectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety State
• Intervention / Treatment: Other: music; Other: operating room noise

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey
    • Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: music group; 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; effect of music on anxiety scores
Active Comparator: operating room noise group; 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; effect of operating room noise on anxiety scores

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): September 15, 2018

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): January 4, 2019
• Last Update Submitted That Met QC Criteria: January 3, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: AntalyaTRH 19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No