ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02220452
Recruitment Status : Recruiting
First Posted : August 20, 2014
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Brief 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 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.

Condition or disease Intervention/treatment Phase
Anesthesia Stress Music Auditory Perception Other: music listening during anesthesia Other: absence of music listening during anesthesia Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Intraoperative Music Listening on Sevoflurane Consumption and Recovery Parameters
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Sevoflurane

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. measurement of prolactin levels [ Time Frame: during the time that patients are anesthetized, an approximate period of 2 hours ]

Other Outcome Measures:
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220452


Contacts
Contact: Kassiani Theodoraki, PhD, DEAA #306974634162 ktheodoraki@hotmail.com

Locations
Greece
Aretaieion University Hospital Recruiting
Athens, Greece, 115 28
Contact: Kassiani Theodoraki, PhD, DEAA    #306974634162    ktheodoraki@hotmail.com   
Principal Investigator: Sofia Vasiloglou, MD         
Sponsors and Collaborators
Aretaieion University Hospital
Investigators
Principal Investigator: Kassiani Theodoraki, PhD, DEAA Aretaieion University Hospital

Publications:
Responsible Party: Dr Kassiani Theodoraki, Associate Professor in Anaesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT02220452     History of Changes
Other Study ID Numbers: Sofia-Music
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General