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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699084
• Other study ID #: MUTHYROID
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: January 15, 2020

Study information

• Verified date: January 2021
• Source: Prolepsis Institute for Preventive, Environmental and Occupational Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Greece	Hygeia Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Heart rate	Heart rate was measured by a patient's monitor.	Change of heart rate was evaluated during the first postoperative day.
Secondary	Respiratory rate	Respiratory rate was measured by a care provider.	Change of respiratory rate was evaluated during the first postoperative day.
Secondary	Oxygen saturation	Oxygen saturation was measured by a patient's monitor.	Change of oxygen saturation was evaluated during the first postoperative day.