search
Back to results

Effect of Music During Carotid Endarterectomy

Primary Purpose

Anxiety State

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music
operating room noise
Sponsored by
Antalya Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety State

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Antalya Training and Research hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

music group

operating room noise group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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"
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)
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.
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.
Differences in pain scores
assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain))
Changes in mean arterial pressure
Assessed every 5 minutes during the procedure
Changes in heart rate
Assessed every 5 minutes during the procedure

Full Information

First Posted
March 1, 2018
Last Updated
January 3, 2019
Sponsor
Antalya Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03457181
Brief Title
Effect of Music During Carotid Endarterectomy
Official Title
Effect of Music on Patient's Anxiety, Satisfaction and Pain During Carotid Endarterectomy: Multicenter Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
September 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antalya Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety State

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
music group
Arm Type
Active Comparator
Arm 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.
Arm Title
operating room noise group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
effect of music on anxiety scores
Intervention Type
Other
Intervention Name(s)
operating room noise
Intervention Description
effect of operating room noise on anxiety scores
Primary Outcome Measure Information:
Title
Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed )
Description
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 Outcome Measure Information:
Title
Differences in intraoperative State-Trait Anxiety Inventory Response (calm)
Description
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
Title
Differences in postoperative anxiety numerical rating scale scores
Description
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
Title
Differences in preoperative State-Trait Anxiety Inventory scores
Description
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
Title
Differences in postoperative State-Trait Anxiety Inventory scores
Description
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
Title
Differences in pain scores
Description
assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain))
Time Frame
10 minutes
Title
Changes in mean arterial pressure
Description
Assessed every 5 minutes during the procedure
Time Frame
60 minutes
Title
Changes in heart rate
Description
Assessed every 5 minutes during the procedure
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Sait Kavakli, M.D.
Organizational Affiliation
Antalya Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research hospital
City
Antalya
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Effect of Music During Carotid Endarterectomy

We'll reach out to this number within 24 hrs