Effect of Music During Carotid Endarterectomy

Anxiety State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03457181
• Other study ID #: AntalyaTRH 19
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: September 15, 2018

Study information

• Verified date: January 2019
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety State

Intervention

Other:
• music
effect of music on anxiety scores
• operating room noise
effect of operating room noise on anxiety scores

Locations

Country	Name	City	State
Turkey	Antalya Training and Research hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Differences in pain scores	assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain))	10 minutes
Secondary	Changes in mean arterial pressure	Assessed every 5 minutes during the procedure	60 minutes
Secondary	Changes in heart rate	Assessed every 5 minutes during the procedure	60 minutes