AnesthesiaNCT02220452
The Effect of Intraoperative Music Listening on Sevoflurane Consumption and Recovery Parameters
A study testing music listening during anesthesia and absence of music listening during anesthesia in people with Anesthesia and Stress, run by Aretaieion University Hospital at 1 site in Greece.
Trial summary
The perioperative period can be a significant source of psychological burden, anxiety and fear for patients Both pharmacological and non-pharmacological methods have been proposed in order to alleviate perioperative stress Music is one of the non-pharmacological methods which have been used in this context, with… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Anesthesia, Stress, Music
- What is being tested?
- music listening during anesthesia and absence of music listening during anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- Aug 2014to Dec 2024
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective hysterectomy for benign disease
Who cannot join
- hearing impairment
- psychiatric disease (depression, dementia)
- mental disability
- concurrent treatment with medication known to affect anesthetic requirement, such as benzodiazepines, anticonvulsants, opioids, psychotropic drugs or alcohol
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieion University Hospital
Athens, 115 28
Kassiani Theodoraki, PhD, DEAA, #306974634162, ktheodoraki@hotmail.com
Sofia Vasiloglou, MD
About this study
- The perioperative period can be a significant source of psychological burden, anxiety and fear for patients
- Both pharmacological and non-pharmacological methods have been proposed in order to alleviate perioperative stress
- Music is one of the non-pharmacological methods which have been used in this context, with favorable effects both preoperatively and postoperatively
- The attenuation of perioperative stress through music listening is probably due to the activation of emotional and cognitive processes that evoke feeling of pleasure and can distract patients' attention from fear and unpleasant thoughts related to the surgical procedure
- Little information is available regarding the effect of intraoperative music listening on anesthetized, unconscious patients
- There is a notion that general anesthesia does not completely abolish auditory perception and that some processing of intraoperative events can occur in unconscious patients, even in the absence of postoperative recall
- The investigators hypothesis is that intraoperative music listening can decrease anesthetic requirements and reduce sevoflurane consumption in female patients subjected to abdominal hysterectomy for benign disease.
Read the detailed description
- The perioperative period can be a significant source of psychological burden, anxiety and fear for patients
- Both pharmacological and non-pharmacological methods have been proposed in order to alleviate perioperative stress
- Music is one of the non-pharmacological methods which have been used in this context, with favorable effects both preoperatively and postoperatively
- Listening to music during the preoperative period has proved useful as an adjunct to premedication and can even be used instead of premedication. Additionally, listening to music postoperatively can also be useful, since it has been related to a more favorable recovery profile and possible attenuation of postoperative pain. In this context, music has also been used in Intensive Care Units, with measurable effects on anxiety scales and hemodynamic parameters. There are also studies investigating the use of music during operations under regional anesthesia, which have shown that music listening substantially decreases the need for anxiolytic administration throughout the operation
- The attenuation of perioperative stress through music listening is probably due to the activation of emotional and cognitive processes that evoke feelings of pleasure and can distract patients' attention from fear and unpleasant thoughts related to the surgical procedure
- Although the favorable effects of music listening during regional anesthesia for the attenuation of intraoperative stress in conscious patients are more or less expected and easily interpreted, less is known regarding the effect of intraoperative music listening on anesthetized, unconscious patients
- Generally, there is a notion that general anesthesia does not completely abolish auditory perception and that some processing of intraoperative events can occur in unconscious patients, even in the absence of postoperative recall
- The preservation of some form of auditory processing during general anesthesia is not necessarily undesirable and can be used to the patient's benefit, since it has been shown that subjecting patients to therapeutic suggestions during general anesthesia can improve recovery parameters or decrease hospital stay
- The investigators hypothesis is that intraoperative music listening can decrease anesthetic requirements. Therefore, the investigators will investigate sevoflurane consumption necessary to achieve a depth of anesthesia corresponding to bispectral index values of 45-55. Female patients subjected to abdominal hysterectomy for benign disease will be randomized to one of two groups: in the first group, audiotapes playing relaxing soothing orchestral music will be placed on the patients' ears after induction of general anesthesia while in the other group the same set of audiotapes will be used without however playing any music
- Sevoflurane consumption will be estimated by weighing the sevoflurane vaporizer in a high-precision scale before induction and after completion of the surgical procedure. Patients will also be queried regarding recall of any sounds or intraoperative events, dreaming while anesthetized and they will be asked to rate their satisfaction from anesthesia. Recovery parameters will also be investigated, such as postoperative nausea and vomiting and the intensity of postoperative pain. To ensure homogeneity, standardized analgesia will be administered in the two groups
- Since prolactin is related to the neuroendocrine response to stress, blood will also be sampled at predetermined timepoints during anesthesia, to detect potential differences between the two groups
- The clinical interest of this study lies in the fact that if a non-costly intervention such as music listening during anesthesia can lead to reduced requirements of anesthetic agents or to reduced need for postoperative analgesia, this theoretically can be translated to a reduction in anesthetic cost. In addition, improvement in recovery profile parameters could lead to a quicker discharge from the post-anesthesia care unit with reduction in turnaround times and overall time optimization.
- Conditions
- Anesthesia, Stress, Music, Auditory Perception
- Being tested
- music listening during anesthesia, absence of music listening during anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music listening during anesthesiaOther
In patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia
absence of music listening during anesthesiaOther
In patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music
| Study group | Role | What they receive |
|---|---|---|
| music listening during anesthesia | Experimental | In patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia Receives: Other: music listening during anesthesia |
| absence of music listening during anesthesia | Active comparator | In patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music Receives: Other: absence of music listening during anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
sevoflurane consumption during general anesthesia
the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined
Measured: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours
Secondary outcomes (6)
recall of postoperative events
a questionnaire will be used to assess the specific outcome measure
Measured: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
recall of postoperative sounds
a questionnaire will be used to assess the specific outcome measure
Measured: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
occurence of postoperative nausea or vomiting
a questionnaire will be used to assess the specific outcome measure
Measured: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
intensity of postoperative pain
a verbal rating scale will be used to assess the specific outcome measure
Measured: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
satisfaction from anesthesia
a verbal rating scale will be used to assess the specific outcome measure
Measured: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
measurement of prolactin levels
Measured: during the time that patients are anesthetized, an approximate period of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DEAA, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02220452
- Sponsor's protocol ID
- Sofia-Music
- Status last verified
- Feb 2023
- First submitted
- 17 Aug 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14.
PubMed 19388893Wang SM, Kulkarni L, Dolev J, Kain ZN. Music and preoperative anxiety: a randomized, controlled study. Anesth Analg. 2002 Jun;94(6):1489-94, table of contents. doi: 10.1097/00000539-200206000-00021.
PubMed 12032013Ganidagli S, Cengiz M, Yanik M, Becerik C, Unal B. The effect of music on preoperative sedation and the bispectral index. Anesth Analg. 2005 Jul;101(1):103-6, table of contents. doi: 10.1213/01.ANE.0000150606.78987.3B.
PubMed 15976214Zhang XW, Fan Y, Manyande A, Tian YK, Yin P. Effects of music on target-controlled infusion of propofol requirements during combined spinal-epidural anaesthesia. Anaesthesia. 2005 Oct;60(10):990-4. doi: 10.1111/j.1365-2044.2005.04299.x.
PubMed 16179044Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Human learning during general anaesthesia and surgery. Br J Anaesth. 1991 Feb;66(2):170-8. doi: 10.1093/bja/66.2.170.
PubMed 1817616Evans C, Richardson PH. Improved recovery and reduced postoperative stay after therapeutic suggestions during general anaesthesia. Lancet. 1988 Aug 27;2(8609):491-3. doi: 10.1016/s0140-6736(88)90131-6.
PubMed 2900410Lindh A, Carlstrom K, Eklund J, Wilking N. Serum steroids and prolactin during and after major surgical trauma. Acta Anaesthesiol Scand. 1992 Feb;36(2):119-24. doi: 10.1111/j.1399-6576.1992.tb03436.x.
PubMed 1532279
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Music Listening on Sevoflurane Consumption and Recovery Parameters
- ClinicalTrials.gov ID
- NCT02220452
- Acronym / sponsor ID
- Sofia-Music
- Conditions
- Anesthesia, Stress, Music, Auditory Perception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Aug 2014 (estimated)
- 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 perioperative period can be a significant source of psychological burden, anxiety and fear for patients
- Both pharmacological and non-pharmacological methods have been proposed in order to alleviate perioperative stress
- Music is one of the non-pharmacological methods which have been used in this context, with favorable effects both preoperatively and postoperatively
- The attenuation of perioperative stress through music listening is probably due to the activation of emotional and cognitive processes that evoke feeling of pleasure and can distract patients' attention from fear and unpleasant thoughts related to the surgical procedure
- Little information is available regarding the effect of intraoperative music listening on anesthetized, unconscious patients
- There is a notion that general anesthesia does not completely abolish auditory perception and that some processing of intraoperative events can occur in unconscious patients, even in the absence of postoperative recall
- The investigators hypothesis is that intraoperative music listening can decrease anesthetic requirements and reduce sevoflurane consumption in female patients subjected to abdominal hysterectomy for benign disease.
Detailed description
- The perioperative period can be a significant source of psychological burden, anxiety and fear for patients
- Both pharmacological and non-pharmacological methods have been proposed in order to alleviate perioperative stress
- Music is one of the non-pharmacological methods which have been used in this context, with favorable effects both preoperatively and postoperatively
- Listening to music during the preoperative period has proved useful as an adjunct to premedication and can even be used instead of premedication. Additionally, listening to music postoperatively can also be useful, since it has been related to a more favorable recovery profile and possible attenuation of postoperative pain. In this context, music has also been used in Intensive Care Units, with measurable effects on anxiety scales and hemodynamic parameters. There are also studies investigating the use of music during operations under regional anesthesia, which have shown that music listening substantially decreases the need for anxiolytic administration throughout the operation
- The attenuation of perioperative stress through music listening is probably due to the activation of emotional and cognitive processes that evoke feelings of pleasure and can distract patients' attention from fear and unpleasant thoughts related to the surgical procedure
- Although the favorable effects of music listening during regional anesthesia for the attenuation of intraoperative stress in conscious patients are more or less expected and easily interpreted, less is known regarding the effect of intraoperative music listening on anesthetized, unconscious patients
- Generally, there is a notion that general anesthesia does not completely abolish auditory perception and that some processing of intraoperative events can occur in unconscious patients, even in the absence of postoperative recall
- The preservation of some form of auditory processing during general anesthesia is not necessarily undesirable and can be used to the patient's benefit, since it has been shown that subjecting patients to therapeutic suggestions during general anesthesia can improve recovery parameters or decrease hospital stay
- The investigators hypothesis is that intraoperative music listening can decrease anesthetic requirements. Therefore, the investigators will investigate sevoflurane consumption necessary to achieve a depth of anesthesia corresponding to bispectral index values of 45-55. Female patients subjected to abdominal hysterectomy for benign disease will be randomized to one of two groups: in the first group, audiotapes playing relaxing soothing orchestral music will be placed on the patients' ears after induction of general anesthesia while in the other group the same set of audiotapes will be used without however playing any music
- Sevoflurane consumption will be estimated by weighing the sevoflurane vaporizer in a high-precision scale before induction and after completion of the surgical procedure. Patients will also be queried regarding recall of any sounds or intraoperative events, dreaming while anesthetized and they will be asked to rate their satisfaction from anesthesia. Recovery parameters will also be investigated, such as postoperative nausea and vomiting and the intensity of postoperative pain. To ensure homogeneity, standardized analgesia will be administered in the two groups
- Since prolactin is related to the neuroendocrine response to stress, blood will also be sampled at predetermined timepoints during anesthesia, to detect potential differences between the two groups
- The clinical interest of this study lies in the fact that if a non-costly intervention such as music listening during anesthesia can lead to reduced requirements of anesthetic agents or to reduced need for postoperative analgesia, this theoretically can be translated to a reduction in anesthetic cost. In addition, improvement in recovery profile parameters could lead to a quicker discharge from the post-anesthesia care unit with reduction in turnaround times and overall time optimization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music listening during anesthesia | Experimental | Other: music listening during anesthesiaIn patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia |
| absence of music listening during anesthesia | Active comparator | Other: absence of music listening during anesthesiaIn patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective hysterectomy for benign disease
Key exclusion criteria (4 listed)
- hearing impairment
- psychiatric disease (depression, dementia)
- mental disability
- concurrent treatment with medication known to affect anesthetic requirement, such as benzodiazepines, anticonvulsants, opioids, psychotropic drugs or alcohol
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 listening during anesthesiaIn patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia | Other | music listening during anesthesia |
| absence of music listening during anesthesiaIn patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music | Other | absence of music listening during anesthesia |
Primary outcome
sevoflurane consumption during general anesthesia
Time frame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours
the sevoflurane vaporizer will be weighed before anesthetic induction and at the end of anesthesia and consequently sevoflurane consumption during anesthesia will be determined
6 secondary outcomes
recall of postoperative events
Time frame: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
recall of postoperative sounds
Time frame: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
occurence of postoperative nausea or vomiting
Time frame: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
intensity of postoperative pain
Time frame: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
satisfaction from anesthesia
Time frame: participants will be followed for the duration of stay in postanesthesia care unit, an average period of 1 hour
measurement of prolactin levels
Time frame: during the time that patients are anesthetized, an approximate period of 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 19388893Bringman H, Giesecke K, Thorne A, Bringman S. Relaxing music as pre-medication before surgery: a randomised controlled trial. Acta Anaesthesiol Scand. 2009 Jul;53(6):759-64. doi: 10.1111/j.1399-6576.2009.01969.x. Epub 2009 Apr 14.
- Background: PubMed 12032013Wang SM, Kulkarni L, Dolev J, Kain ZN. Music and preoperative anxiety: a randomized, controlled study. Anesth Analg. 2002 Jun;94(6):1489-94, table of contents. doi: 10.1097/00000539-200206000-00021.
- Background: PubMed 15976214Ganidagli S, Cengiz M, Yanik M, Becerik C, Unal B. The effect of music on preoperative sedation and the bispectral index. Anesth Analg. 2005 Jul;101(1):103-6, table of contents. doi: 10.1213/01.ANE.0000150606.78987.3B.
- Background: PubMed 16179044Zhang XW, Fan Y, Manyande A, Tian YK, Yin P. Effects of music on target-controlled infusion of propofol requirements during combined spinal-epidural anaesthesia. Anaesthesia. 2005 Oct;60(10):990-4. doi: 10.1111/j.1365-2044.2005.04299.x.
- Background: PubMed 1817616Block RI, Ghoneim MM, Sum Ping ST, Ali MA. Human learning during general anaesthesia and surgery. Br J Anaesth. 1991 Feb;66(2):170-8. doi: 10.1093/bja/66.2.170.
- Background: PubMed 2900410Evans C, Richardson PH. Improved recovery and reduced postoperative stay after therapeutic suggestions during general anaesthesia. Lancet. 1988 Aug 27;2(8609):491-3. doi: 10.1016/s0140-6736(88)90131-6.
- Background: PubMed 1532279Lindh A, Carlstrom K, Eklund J, Wilking N. Serum steroids and prolactin during and after major surgical trauma. Acta Anaesthesiol Scand. 1992 Feb;36(2):119-24. doi: 10.1111/j.1399-6576.1992.tb03436.x.
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Kassiani Theodoraki, PhD, DEAA principal investigator
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music listening during anesthesia and absence of music listening during anesthesia in people with Anesthesia and Stress, run by Aretaieion University Hospital 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 4 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassiani Theodoraki, PhD, DEAA (#306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sevoflurane consumption during general anesthesia (time frame: change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours). 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 NCT02220452, which also lists 7 linked publications.
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 8 Feb 2023.