The Effects of Instrumental Music on Intraoperative Parameters and Postoperative Pain and Side Effects

Evaluation of Music Effects on Intraoperative and Postoperative Parameters

The clinical study started after receiving ethical approval from the Clinical Research Ethics Committee of Van Yüzüncü Yıl University and obtaining patient consent. Eighty patients with an ASA (American Society of Anesthesiologists) I-II physical status at the ages of 20-60 for whom elective thyroidectomy surgery was planned were included in the study. The patients were randomly divided into two groups, music group (Group M) and control group (Group K). The intraoperative vital signs of the patients (heart rate, blood pressure and saturation), bispectral index (BIS) values, train-of-four (TOF) values, additional doses of opioid and muscle relaxant needs and complications were recorded. The 0th hour, 3rd hour and 6th hour Visual Analogue Scale (VAS) scores of the patients were measured and recorded. (The 0th hour at the end of the operation was accepted as the moment of reaching a Modified Aldrete Score of >9)

Study Overview

• Status: Completed
• Conditions: Music and Anesthesia
• Intervention / Treatment: Other: music sound therapy

Detailed Description

This study was conducted at Yüzüncü Yıl University Dursun Odabaş Medical Center after the approval of Van Yüzüncü Yıl University Non-Interventional Clinical Research Ethics Committee and the verbal and written consent of the patients.

2.1. Population Patients with ASA I-II functional status, aged 20-60 years, who agreed to participate in the study and were scheduled for thyroidectomy under general anesthesia under elective conditions were included. Patients with emergency and bleeding, those who would undergo other surgery, those who refused to participate in the study, those with hearing problems, those who could not cooperate (due to dementia, mental retardation, etc.), those with drug or alcohol addiction, and obese patients with a BMI≥30 were excluded from the study. The patients were randomly divided into two groups as music group (Group M) and control group (Group K) by sealed tender. 40 patients in each group and a total of 80 patients were included in the study. Closed envelopes determining which group the patient would belong to were randomly selected by the patient. The patients who would participate in the study were evaluated preoperatively in the Anesthesiology and Reanimation outpatient clinic the day before and were informed about the study. Except for routine preoperative evaluation tests (hemogram, fasting blood sugar, sodium, potassium, calcium, urea, creatinine, AST (aspartate aminotransferase), ALT (alanine aminotransferase), coagulation parameters), no additional tests were requested.

The demographic data (age, weight, height, gender, body mass index (BMI)) of the patients were recorded.

2.2. Anesthesia Management Routine standard ASA monitoring electrocardiography (ECG), peripheral oxygen saturation (SpO2), heart rate (HR), non-invasive blood pressure monitoring), bispectral index monitoring (A-2000 Aspect medical systems, USA), and neuromuscular monitoring (TOF) were performed Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (map), heart rate (HR), SpO2, BIS, and TOF values were recorded. Initial values before surgery -5th-minute values were accepted and the values were recorded as of the 0th minute after the surgical incision. Measurements were taken at 5 minutes intervals in the first half hour after the start of surgery, and then at 10 minutes intervals.After the patients were placed in the appropriate position, Group M patients were fitted with headphones that covered the entire ear and suppressed hearing of the sounds in the operating room. The level of the music sound was adjusted to the level where patients felt comfortable by asking them before induction. Until the anesthetic gases ceased, relaxing instrumental classical music which is selected by us and recorded on the SD card, was played during the entire operation.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Van, Turkey, 65100
    • Arzu Esen Tekeli
  • Van, Turkey, 65100
    • Van Yüzüncü Yil University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA I-II functional status,
• 20-60 years
• agreed to participate in the study
• scheduled for thyroidectomy under general anesthesia

Exclusion Criteria:

• emergence cases
• bleeding cases
• other surgeries
• refused to participate in the study,
• have hearing problems
• could not cooperate (due to dementia, mental retardation, etc.)
• drug or alcohol addiction,
• obese patients with a BMI≥30

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: music group (Group M); Group M patients were fitted with headphones that covered the entire ear and suppressed hearing of the sounds in the operating room. The level of the music sound was adjusted to the level where patients felt comfortable by asking them before induction. Mean arterial pressure (MAP) greater than 20% of the initial value for one minute or longer was first evaluated in favor of superficial anesthesia, while its continuation was considered hypertension. If the TOF value was higher than 70 for a long time, 0.1 mg/kg rocuronium iv was administered, and 50 µg fentanyl iv was administered in the need for opioids. In the last 20 minutes of the surgical period, 1 mg/kg tramadol and 20 mg/kg paracetamol IV were administered to all patients in accordance with conventional treatment for postoperative analgesia.

Other: music sound therapy; investigate the effects of music on intraoperative hemodynamic parameters, anesthesia depth, muscle relaxant consumption, analgesic consumption and pain and side effects (nausea, vomiting, tremor) in the early postoperative period in patients undergoing thyroidectomy operation under general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	intraoperative vital signs of the patients (heart rate)	1 day of surgery
non invasive blood pressure	intraoperative vital signs of the patients ( non invasive blood pressure)	1 day of surgery
Pulse oxymeter	Intraoperative measurements	1 day of surgery
BIS (Bispektral index)	For monitoring being awake	15 minutes
level of opioid	additional opioid	30 minutes
muscle relaxant	additional muscle relaxant	40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	The patients were followed up for side effects	0., 3., 6. hours
VAS scores	VAS 0-2: no pain, 3-4: dull pain, 5-6: moderate pain, 7-8: acute pain, 9-10: unbearable pain.	Postoperative 0th hour (0th hour was considered as the moment when Modified Aldrete Score >9), 3rd hour, and 6th- hour VAS scores of all cases were recorded.

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Investigators: Study Chair: Yüzüncu Yıl University Medicine School, Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): September 2, 2020
• Study Completion (Actual): December 2, 2020

Study Registration Dates

• First Submitted: May 13, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Estimated): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: anesthesia; Bispectral index; music; Train of four
• Other Study ID Numbers: 2023/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a retrospective study. We will share our results. W e dont plan to share participiants values

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No