The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy

To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Mozart music

Detailed Description

Postoperative pain is a major concern in postsurgical patients. Meanwhile, there is a general consensus on minimizing the use of analgesic drugs in patients undergoing total thyroidectomy. Therefore, alternative methods need to be investigated in order to reduce postoperative pain. Although the clinical importance of music has been recognised in other pathological situations, further research is needed to investigate the effect of music on postoperative pain.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 15123
    • Hygeia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults scheduled for total thyroidectomy under general anesthesia

Exclusion Criteria:

• Visual impairments
• Hearing impairments
• Severe anxiety or other psychiatric disorders
• History of chronic pain
• Past complications during anesthesia or surgery
• American Society of Anesthesiologists (ASA) physical status beyond II

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Music Group; Patients received music intervention and usual postoperative care.	Other: Mozart music; A 20-minute piece composed by W.A Mozart ( Sonata K. 448 in D Major for 2 pianos) was applied in music group, directly after the arrival of patients in the Post Anesthesia Care Unit (PACU), while they were receiving usual postoperative care.
NO_INTERVENTION: Control Group; Patients received only postoperative usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	Postoperative Pain was measured with the Visual Analogue Scale (VAS). This is a straight horizontal line of fixed length, usually 100 mm. The ends of the line are defined as the extreme limits of the measured parameter (pain). Specifically, the left end signifies the complete absence of pain and the right end represents the worst possible pain. Patients were asked to rate their pain by indicating a point on the straight line. Higher VAS scores mean more pain intensity. The more is the reduction of VAS score from the baseline measurement, the better is the outcome.	Change of VAS was evaluated; from the beginning (time of arrival at the PACU, baseline), to the middle (10 minutes after surgery), to the end of the music intervention (20 minutes after surgery) at the PACU and to 2 hours after surgery in the ward.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic and diastolic blood pressure	Blood pressure was measured by a patient's monitor.	Change of blood pressure was evaluated during the first postoperative day.
Heart rate	Heart rate was measured by a patient's monitor.	Change of heart rate was evaluated during the first postoperative day.
Respiratory rate	Respiratory rate was measured by a care provider.	Change of respiratory rate was evaluated during the first postoperative day.
Oxygen saturation	Oxygen saturation was measured by a patient's monitor.	Change of oxygen saturation was evaluated during the first postoperative day.

Collaborators and Investigators

• Sponsor: Prolepsis Institute for Preventive, Environmental and Occupational Medicine
• Investigators: Principal Investigator: Dimitrios Linos, MD, Ph.D., Hygeia Hospital, National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2018
• Primary Completion (ACTUAL): January 15, 2020
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (ACTUAL): January 7, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: MUTHYROID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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