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Completed

NCT Number: NCT03457181

Effect of Music During Carotid Endarterectomy

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.

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Key information

Conditions

Anxiety State Anxiety Disorders Mental Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research hospital

Antalya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

effect of music on anxiety scores

operating room noise

Other

effect of operating room noise on anxiety scores

Primary outcomes

  1. Differences in intraoperative State-Trait Anxiety Inventory Response (relaxed )

    Time frame: 60 minutes

    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 outcomes

  1. Differences in intraoperative State-Trait Anxiety Inventory Response (calm)

    Time frame: 60 minutes

    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"

  2. Differences in postoperative anxiety numerical rating scale scores

    Time frame: 10 minutes

    assessed 5 min after the procedure. Numeric Rating Scale (NRS): from 0 (no anxiety) to 10 (worst feeling of anxiety possible)

  3. Differences in preoperative State-Trait Anxiety Inventory scores

    Time frame: 20 minutes

    assessed 1 day before surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.

  4. Differences in postoperative State-Trait Anxiety Inventory scores

    Time frame: 20 minutes

    assessed 1st day after surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.

  5. Differences in pain scores

    Time frame: 10 minutes

    assessed 5th min after surgery. (from 0 (no pain) to 10 (maximal possible pain))

  6. Changes in mean arterial pressure

    Time frame: 60 minutes

    Assessed every 5 minutes during the procedure

  7. Changes in heart rate

    Time frame: 60 minutes

    Assessed every 5 minutes during the procedure

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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