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Completed

NCT Number: NCT04699084

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hygeia Hospital

Athens, 15123, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mozart music

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Prolepsis Institute for Preventive, Environmental and Occupational Medicine

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 7, 2021
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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