Effect of Music During Carotid Endarterectomy

Antalya Training and Research Hospital

Status: Completed

Conditions: Anxiety State

Treatments: Other: operating room noise; Other: music

Study type: Interventional

Funder types: Other

Identifiers

NCT03457181

AntalyaTRH 19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

music group

Active Comparator group

Description:

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.

Treatment:

Other: music

operating room noise group

Active Comparator group

Description:

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.

Treatment:

Other: operating room noise