Music and AnesthesiaNCT05886231
The Effects of Instrumental Music on Intraoperative Parameters and Postoperative Pain and Side Effects
A study testing music sound therapy in people with Music and Anesthesia, run by Yuzuncu Yil University at 2 sites in Turkey (Türkiye).
Trial summary
The clinical study started after receiving ethical approval from the Clinical Research Ethics Committee of Van Yüzüncü Yıl University and obtaining patient consent. Eighty patients with an ASA (American Society of Anesthesiologists) I-II physical status at the ages of 20-60 for whom elective thyroidectomy surgery was… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Music and Anesthesia
- What is being tested?
- music sound therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 2 Mar 2020to 2 Dec 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I-II functional status,
- 20-60 years
- agreed to participate in the study
- scheduled for thyroidectomy under general anesthesia
Who cannot join
- emergence cases
- bleeding cases
- other surgeries
- refused to participate in the study,
- have hearing problems
- could not cooperate (due to dementia, mental retardation, etc.)
- drug or alcohol addiction,
- obese patients with a BMI≥30
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Arzu Esen Tekeli
Van, 65100
Van Yüzüncü Yil University
Van, 65100
About this study
Official title: Evaluation of Music Effects on Intraoperative and Postoperative Parameters
The clinical study started after receiving ethical approval from the Clinical Research Ethics Committee of Van Yüzüncü Yıl University and obtaining patient consent. Eighty patients with an ASA (American Society of Anesthesiologists) I-II physical status at the ages of 20-60 for whom elective thyroidectomy surgery was planned were included in the study. The patients were randomly divided into two groups, music group (Group M) and control group (Group K). The intraoperative vital signs of the patients (heart rate, blood pressure and saturation), bispectral index (BIS) values, train-of-four (TOF) values, additional doses of opioid and muscle relaxant needs and complications were recorded. The 0th hour, 3rd hour and 6th hour Visual Analogue Scale (VAS) scores of the patients were measured and recorded. (The 0th hour at the end of the operation was accepted as the moment of reaching a Modified Aldrete Score of >9)
Read the detailed description
This study was conducted at Yüzüncü Yıl University Dursun Odabaş Medical Center after the approval of Van Yüzüncü Yıl University Non-Interventional Clinical Research Ethics Committee and the verbal and written consent of the patients.
2.1. Population Patients with ASA I-II functional status, aged 20-60 years, who agreed to participate in the study and were scheduled for thyroidectomy under general anesthesia under elective conditions were included. Patients with emergency and bleeding, those who would undergo other surgery, those who refused to participate in the study, those with hearing problems, those who could not cooperate (due to dementia, mental retardation, etc.), those with drug or alcohol addiction, and obese patients with a BMI≥30 were excluded from the study. The patients were randomly divided into two groups as music group (Group M) and control group (Group K) by sealed tender. 40 patients in each group and a total of 80 patients were included in the study. Closed envelopes determining which group the patient would belong to were randomly selected by the patient. The patients who would participate in the study were evaluated preoperatively in the Anesthesiology and Reanimation outpatient clinic the day before and were informed about the study. Except for routine preoperative evaluation tests (hemogram, fasting blood sugar, sodium, potassium, calcium, urea, creatinine, AST (aspartate aminotransferase), ALT (alanine aminotransferase), coagulation parameters), no additional tests were requested.
The demographic data (age, weight, height, gender, body mass index (BMI)) of the patients were recorded.
2.2. Anesthesia Management Routine standard ASA monitoring electrocardiography (ECG), peripheral oxygen saturation (SpO2), heart rate (HR), non-invasive blood pressure monitoring), bispectral index monitoring (A-2000 Aspect medical systems, USA), and neuromuscular monitoring (TOF) were performed Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (map), heart rate (HR), SpO2, BIS, and TOF values were recorded. Initial values before surgery -5th-minute values were accepted and the values were recorded as of the 0th minute after the surgical incision. Measurements were taken at 5 minutes intervals in the first half hour after the start of surgery, and then at 10 minutes intervals.After the patients were placed in the appropriate position, Group M patients were fitted with headphones that covered the entire ear and suppressed hearing of the sounds in the operating room. The level of the music sound was adjusted to the level where patients felt comfortable by asking them before induction. Until the anesthetic gases ceased, relaxing instrumental classical music which is selected by us and recorded on the SD card, was played during the entire operation.
- Conditions
- Music and Anesthesia
- Being tested
- music sound therapy
- Keywords
- music, anesthesia, Train of four, Bispectral index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music sound therapyOther
investigate the effects of music on intraoperative hemodynamic parameters, anesthesia depth, muscle relaxant consumption, analgesic consumption and pain and side effects (nausea, vomiting, tremor) in the early postoperative period in patients undergoing thyroidectomy operation under general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| music group (Group M) | Experimental | Group M patients were fitted with headphones that covered the entire ear and suppressed hearing of the sounds in the operating room. The level of the music sound was adjusted to the level where patients felt comfortable by asking them before induction.
Mean arterial pressure (MAP) greater than 20% of the initial value for one minute or longer was first evaluated in favor of superficial anesthesia, while its continuation was considered hypertension.
If the TOF value was higher than 70 for a long time, 0.1 mg/kg rocuronium iv was administered, and 50 µg fentanyl iv was administered in the need for opioids. In the last 20 minutes of the surgical period, 1 mg/kg tramadol and 20 mg/kg paracetamol IV were administered to all patients in accordance with conventional treatment for postoperative analgesia. Receives: Other: music sound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
heart rate
intraoperative vital signs of the patients (heart rate)
Measured: 1 day of surgery
non invasive blood pressure
intraoperative vital signs of the patients ( non invasive blood pressure)
Measured: 1 day of surgery
Pulse oxymeter
Intraoperative measurements
Measured: 1 day of surgery
BIS (Bispektral index)
For monitoring being awake
Measured: 15 minutes
level of opioid
additional opioid
Measured: 30 minutes
muscle relaxant
additional muscle relaxant
Measured: 40 minutes
Secondary outcomes (2)
Side effects
The patients were followed up for side effects
Measured: 0., 3., 6. hours
VAS scores
VAS 0-2: no pain, 3-4: dull pain, 5-6: moderate pain, 7-8: acute pain, 9-10: unbearable pain.
Measured: Postoperative 0th hour (0th hour was considered as the moment when Modified Aldrete Score >9), 3rd hour, and 6th- hour VAS scores of all cases were recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start2 Mar 2020
- Primary completion2 Sep 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music and AnesthesiaStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Retrospective
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Esen Tekeli, Yuzuncu Yil University
- Investigators
- Yüzüncu Yıl University Medicine School, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886231
- Sponsor's protocol ID
- 2023/1
- Status last verified
- May 2023
- First submitted
- 13 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a retrospective study. We will share our results. W e dont plan to share participiants values
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Music Effects on Intraoperative and Postoperative Parameters
- ClinicalTrials.gov ID
- NCT05886231
- Acronym / sponsor ID
- 2023/1
- Conditions
- Music and Anesthesia
- Keywords
- music, anesthesia, Train of four, Bispectral index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 2 Jun 2023 (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.
The clinical study started after receiving ethical approval from the Clinical Research Ethics Committee of Van Yüzüncü Yıl University and obtaining patient consent. Eighty patients with an ASA (American Society of Anesthesiologists) I-II physical status at the ages of 20-60 for whom elective thyroidectomy surgery was planned were included in the study. The patients were randomly divided into two groups, music group (Group M) and control group (Group K). The intraoperative vital signs of the patients (heart rate, blood pressure and saturation), bispectral index (BIS) values, train-of-four (TOF) values, additional doses of opioid and muscle relaxant needs and complications were recorded. The 0th hour, 3rd hour and 6th hour Visual Analogue Scale (VAS) scores of the patients were measured and recorded. (The 0th hour at the end of the operation was accepted as the moment of reaching a Modified Aldrete Score of >9)
Detailed description
This study was conducted at Yüzüncü Yıl University Dursun Odabaş Medical Center after the approval of Van Yüzüncü Yıl University Non-Interventional Clinical Research Ethics Committee and the verbal and written consent of the patients.
2.1. Population Patients with ASA I-II functional status, aged 20-60 years, who agreed to participate in the study and were scheduled for thyroidectomy under general anesthesia under elective conditions were included. Patients with emergency and bleeding, those who would undergo other surgery, those who refused to participate in the study, those with hearing problems, those who could not cooperate (due to dementia, mental retardation, etc.), those with drug or alcohol addiction, and obese patients with a BMI≥30 were excluded from the study. The patients were randomly divided into two groups as music group (Group M) and control group (Group K) by sealed tender. 40 patients in each group and a total of 80 patients were included in the study. Closed envelopes determining which group the patient would belong to were randomly selected by the patient. The patients who would participate in the study were evaluated preoperatively in the Anesthesiology and Reanimation outpatient clinic the day before and were informed about the study. Except for routine preoperative evaluation tests (hemogram, fasting blood sugar, sodium, potassium, calcium, urea, creatinine, AST (aspartate aminotransferase), ALT (alanine aminotransferase), coagulation parameters), no additional tests were requested.
The demographic data (age, weight, height, gender, body mass index (BMI)) of the patients were recorded.
2.2. Anesthesia Management Routine standard ASA monitoring electrocardiography (ECG), peripheral oxygen saturation (SpO2), heart rate (HR), non-invasive blood pressure monitoring), bispectral index monitoring (A-2000 Aspect medical systems, USA), and neuromuscular monitoring (TOF) were performed Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (map), heart rate (HR), SpO2, BIS, and TOF values were recorded. Initial values before surgery -5th-minute values were accepted and the values were recorded as of the 0th minute after the surgical incision. Measurements were taken at 5 minutes intervals in the first half hour after the start of surgery, and then at 10 minutes intervals.After the patients were placed in the appropriate position, Group M patients were fitted with headphones that covered the entire ear and suppressed hearing of the sounds in the operating room. The level of the music sound was adjusted to the level where patients felt comfortable by asking them before induction. Until the anesthetic gases ceased, relaxing instrumental classical music which is selected by us and recorded on the SD card, was played during the entire operation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective
| Arm | Type | Receives |
|---|---|---|
| music group (Group M) | Experimental | Other: music sound therapyGroup M patients were fitted with headphones that covered the entire ear and suppressed hearing of the sounds in the operating room. The level of the music sound was adjusted to the level where patients felt comfortable by asking them before induction. Mean arterial pressure (MAP) greater than 20% of the initial value for one minute or longer was first evaluated in favor of superficial anesthesia, while its continuation was considered hypertension. If the TOF value was higher than 70 for a long time, 0.1 mg/kg rocuronium iv was administered, and 50 µg fentanyl iv was administered in the need for opioids. In the last 20 minutes of the surgical period, 1 mg/kg tramadol and 20 mg/kg paracetamol IV were administered to all patients in accordance with conventional treatment for postoperative analgesia. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I-II functional status,
- 20-60 years
- agreed to participate in the study
- scheduled for thyroidectomy under general anesthesia
Key exclusion criteria (8 listed)
- emergence cases
- bleeding cases
- other surgeries
- refused to participate in the study,
- have hearing problems
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 |
|---|---|---|
| music sound therapyinvestigate the effects of music on intraoperative hemodynamic parameters, anesthesia depth, muscle relaxant consumption, analgesic consumption and pain and side effects (nausea, vomiting, tremor) in the early postoperative period in patients undergoing thyroidectomy operation under general anesthesia. | Other | music group (Group M) |
Primary outcome
heart rate
Time frame: 1 day of surgery
intraoperative vital signs of the patients (heart rate)
non invasive blood pressure
Time frame: 1 day of surgery
intraoperative vital signs of the patients ( non invasive blood pressure)
Pulse oxymeter
Time frame: 1 day of surgery
Intraoperative measurements
BIS (Bispektral index)
Time frame: 15 minutes
For monitoring being awake
level of opioid
Time frame: 30 minutes
additional opioid
muscle relaxant
Time frame: 40 minutes
additional muscle relaxant
2 secondary outcomes
Side effects
Time frame: 0., 3., 6. hours
VAS scores
Time frame: Postoperative 0th hour (0th hour was considered as the moment when Modified Aldrete Score >9), 3rd hour, and 6th- hour VAS scores of all cases were recorded.
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 2 Jun 2023.
- Individual participant dataSharing planned: No. This is a retrospective study. We will share our results. W e dont plan to share participiants values
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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.
Yüzüncu Yıl University Medicine School study chair
Yuzuncu Yil University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music sound therapy in people with Music and Anesthesia, run by Yuzuncu Yil University at 2 sites in Turkey (Türkiye).
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 4 inclusion and 8 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 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
heart rate (time frame: 1 day of surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2023.