The Effect of Intraoperative Music Listening on Sevoflurane Consumption and Recovery Parameters

February 5, 2023 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital
  • 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 115 28
        • Recruiting
        • ARETAIEION University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective hysterectomy for benign disease

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: music listening during anesthesia
In 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
In patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia
ACTIVE_COMPARATOR: absence of music listening during anesthesia
In 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
In patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
change of sevoflurane vaporizer weight from before induction to end of anesthesia, an average period of 2 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
a questionnaire will be used to assess the specific outcome measure
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
a questionnaire will be used to assess the specific outcome measure
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
a questionnaire will be used to assess the specific outcome measure
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
a verbal rating scale will be used to assess the specific outcome measure
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
a verbal rating scale will be used to assess the specific outcome measure
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
during the time that patients are anesthetized, an approximate period of 2 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
sleep diary
Time Frame: first postoperative night
a questionnaire will be used to assess the specific outcome measure and participants will be queried in the first postoperative morning
first postoperative night
sleep diary
Time Frame: second postoperative night
a questionnaire will be used to assess the specific outcome measure and participants will be queried in the second postoperative morning
second postoperative night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aretaieion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2014

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Sofia-Music

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