Effect of Music During Carotid Endarterectomy

NCT ID: NCT03457181

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2018-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

music

Intervention Type OTHER

effect of music on anxiety scores

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.

Group Type ACTIVE_COMPARATOR

operating room noise

Intervention Type OTHER

effect of operating room noise on anxiety scores

Interventions

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music

effect of music on anxiety scores

Intervention Type OTHER

operating room noise

effect of operating room noise on anxiety scores

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antalya Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ali Sait Kavakli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Antalya Training and Research Hospital

Locations

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Antalya Training and Research hospital

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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AntalyaTRH 19

Identifier Type: -

Identifier Source: org_study_id

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