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Clinical Trials/NCT04699084
NCT04699084CompletedNot Applicable

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

Prolepsis Institute for Preventive, Environmental and Occupational Medicine2 sites in 1 country50 target enrollmentStarted: February 20, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
2
Primary Endpoint
Postoperative Pain

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 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 Outcomes

  • Heart rate(Change of heart rate was evaluated during the first postoperative day.)
  • Respiratory rate(Change of respiratory rate was evaluated during the first postoperative day.)
  • Systolic and diastolic blood pressure(Change of blood pressure was evaluated during the first postoperative day.)
  • Oxygen saturation(Change of oxygen saturation was evaluated during the first postoperative day.)

Investigators

Sponsor
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dimitrios Linos

Principal Investigator

Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Study Sites (2)

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