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

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ClinicalTrials.gov Identifier: NCT04699084
Recruitment Status : Completed
First Posted : January 7, 2021
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Dimitrios Linos, Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Study Description
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Brief Summary:
To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.

Condition or disease Intervention/treatment Phase
Postoperative Pain Other: Mozart music Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were assigned to two groups. One group underwent a music intervention postoperatively, while the other received only usual postoperative care (control group).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : January 15, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Systolic and diastolic blood pressure [ Time Frame: Change of blood pressure was evaluated during the first postoperative day. ]
    Blood pressure was measured by a patient's monitor.

  2. Heart rate [ Time Frame: Change of heart rate was evaluated during the first postoperative day. ]
    Heart rate was measured by a patient's monitor.

  3. Respiratory rate [ Time Frame: Change of respiratory rate was evaluated during the first postoperative day. ]
    Respiratory rate was measured by a care provider.

  4. Oxygen saturation [ Time Frame: Change of oxygen saturation was evaluated during the first postoperative day. ]
    Oxygen saturation was measured by a patient's monitor.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04699084


Locations
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Greece
Hygeia Hospital
Athens, Greece, 15123
Sponsors and Collaborators
Prolepsis Institute for Preventive, Environmental and Occupational Medicine
Investigators
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Principal Investigator: Dimitrios Linos, MD, Ph.D. Hygeia Hospital, National and Kapodistrian University of Athens
More Information
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Responsible Party: Dimitrios Linos, Principal Investigator, Prolepsis Institute for Preventive, Environmental and Occupational Medicine
ClinicalTrials.gov Identifier: NCT04699084    
Other Study ID Numbers: MUTHYROID
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations