Postoperative PainNCT04699084
The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy
A study testing Mozart music in people with Postoperative Pain, run by Prolepsis Institute for Preventive, Environmental and Occupational Medicine at 1 site in Greece.
Trial summary
To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Mozart music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 20 Feb 2018to 15 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults scheduled for total thyroidectomy under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the effect of Mozart music on postoperative pain and physiological parameters in patients after total thyroidectomy.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Mozart music
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mozart musicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | Patients received music intervention and usual postoperative care. Receives: Other: Mozart music |
| Control Group | No intervention | Patients received only postoperative usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (4)
Systolic and diastolic blood pressure
Blood pressure was measured by a patient's monitor.
Measured: Change of blood pressure was evaluated during the first postoperative day.
Heart rate
Heart rate was measured by a patient's monitor.
Measured: Change of heart rate was evaluated during the first postoperative day.
Respiratory rate
Respiratory rate was measured by a care provider.
Measured: Change of respiratory rate was evaluated during the first postoperative day.
Oxygen saturation
Oxygen saturation was measured by a patient's monitor.
Measured: Change of oxygen saturation was evaluated during the first postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start20 Feb 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prolepsis Institute for Preventive, Environmental and Occupational Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Linos, Prolepsis Institute for Preventive, Environmental and Occupational Medicine
- Investigators
- Dimitrios Linos, MD, Ph.D., Principal investigator, Hygeia Hospital, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699084
- Sponsor's protocol ID
- MUTHYROID
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tripyla N, Katsas K, Karagkouni K, Liosis I, Ntelis S, Linos D. Evaluation of the effect of Mozart music on pain and respiratory rate after thyroidectomy. Hormones (Athens). 2023 Mar;22(1):113-119. doi: 10.1007/s42000-022-00421-7. Epub 2022 Nov 22.
PubMed 36418659
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Mozart Music on Pain and Respiratory Rate After Thyroidectomy
- ClinicalTrials.gov ID
- NCT04699084
- Acronym / sponsor ID
- MUTHYROID
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prolepsis Institute for Preventive, Environmental and Occupational MedicineUniversity, hospital or other
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Other: Mozart musicPatients received music intervention and usual postoperative care. |
| Control Group | No intervention | –Patients received only postoperative usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults scheduled for total thyroidectomy under general anesthesia
Key exclusion criteria (6 listed)
- Visual impairments
- Hearing impairments
- Severe anxiety or other psychiatric disorders
- History of chronic pain
- Past complications during anesthesia or surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mozart musicA 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. | Other | Music Group |
Primary outcome
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.
4 secondary outcomes
Systolic and diastolic blood pressure
Time frame: Change of blood pressure was evaluated during the first postoperative day.
Heart rate
Time frame: Change of heart rate was evaluated during the first postoperative day.
Respiratory rate
Time frame: Change of respiratory rate was evaluated during the first postoperative day.
Oxygen saturation
Time frame: Change of oxygen saturation was evaluated during the first postoperative day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Derived from this study: PubMed 36418659Tripyla N, Katsas K, Karagkouni K, Liosis I, Ntelis S, Linos D. Evaluation of the effect of Mozart music on pain and respiratory rate after thyroidectomy. Hormones (Athens). 2023 Mar;22(1):113-119. doi: 10.1007/s42000-022-00421-7. Epub 2022 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitrios Linos, MD, Ph.D. principal investigator
Hygeia Hospital, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mozart music in people with Postoperative Pain, run by Prolepsis Institute for Preventive, Environmental and Occupational Medicine at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.