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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Other: Mozart music

• Registration Number: NCT04699084
• Lead Sponsor: Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Brief Summary

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

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 Timeline

• Study Start: 2018-02-20
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Group	Mozart music	Patients received music intervention and usual postoperative care.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	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.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hygeia Hospital; 🇬🇷 Athens, Greece