<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04468048</url>
  </required_header>
  <id_info>
    <org_study_id>1309407-1</org_study_id>
    <nct_id>NCT04468048</nct_id>
  </id_info>
  <brief_title>Music Utilization in Sedation and Induction in Colonoscopy</brief_title>
  <acronym>MUSIC</acronym>
  <official_title>Music Utilization in Sedation and Induction in Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Brooklyn Hospital Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Brooklyn Hospital Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Conscious sedation (CS) if often used in the field of gastroenterology to alleviate pain and&#xD;
      discomfort with interventional procedures. Although CS is relatively safe, there is concern&#xD;
      for the development of cardiopulmonary complications. Music has been shown in multiple&#xD;
      studies to decrease anxiety and improve patient satisfaction following cardiac, pulmonary,&#xD;
      and surgical procedures. This is a prospective single-blinded randomized control trial that&#xD;
      will examine the effects of active music participation and music listening on patients&#xD;
      undergoing colonoscopy through propofol use (monitored anesthesia) at The Brooklyn Hospital&#xD;
      Center. The study will enroll patients who will undergo colonoscopy from November 2018 to&#xD;
      April 2019 and randomize them to receive music or no music starting at the initial nursing&#xD;
      evaluation in the pre-procedure area. We hypothesize that incorporating music during&#xD;
      colonoscopy procedures will alleviate patient discomfort, reduce narcotic/sedative usage and&#xD;
      post-operative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Conscious sedation (CS) in the field of gastroenterology is commonly&#xD;
      incorporated in order to alleviate pain and discomfort associated with interventional&#xD;
      procedures. The use of CS to combat patient anxiety has been well documented [1]. Although CS&#xD;
      is relatively safe, it is not immune to cardiopulmonary complications. Multiple studies have&#xD;
      demonstrated a clear correlation between advancing age and procedure related complications&#xD;
      [2-4]. It is also important to note that despite the lack of association between age and&#xD;
      additional complications in a study conducted by Clarke et al, a third of their patients did&#xD;
      not receive sedation/narcotic medications [5].&#xD;
&#xD;
      Obesity, which affects approximately two third of the U.S. population, has a myriad of health&#xD;
      related risks and has been shown to contribute to the overall complications associated with&#xD;
      endoscopic procedures [6]. Because those who are obese and overweight have higher than normal&#xD;
      BMIs, BMI should not be ignored when assessing cardiopulmonary complications in patients&#xD;
      undergoing endoscopic procedures. Moreover, a study by Qadeer et al. revealed that patients&#xD;
      with high BMIs were more likely to experience hypoxic episodes [3].&#xD;
&#xD;
      A study by Sharma et al. (2007) looked at more than 300,000 patients who underwent endoscopic&#xD;
      procedures while monitoring their risk factors for cardiopulmonary complications [4]. Older&#xD;
      age, American Society of Anesthesia (ASA) grade value &gt;2, inpatient procedures, and&#xD;
      involvement of trainee with procedure were all shown to be associated with cardiopulmonary&#xD;
      complications. In addition, another study by Bini et al.(2003) illustrated that the age of a&#xD;
      patient, comorbid conditions, month of procedure (July and August), and midazolam dose were&#xD;
      linked with increased negative outcomes [2]. The correlation between complication rate during&#xD;
      procedures along with the year of the trainee conducting the procedure indirectly&#xD;
      demonstrated the complications in the new academic year (July and August). Understanding that&#xD;
      sedation during endoscopic procedures incurs significant risks particularly in patients who&#xD;
      are underweight, obese or have numerous comorbidities can lead to steps aimed at better&#xD;
      managing the aforementioned risks and reducing patient discomfort.&#xD;
&#xD;
      Music has been shown in many studies to decrease anxiety and improve patient satisfaction&#xD;
      during and after procedures in cardiac, pulmonary and surgical procedures [7-16]. In regards&#xD;
      to endoscopies, one hundred and eighty patients who were listening to music prior to&#xD;
      endoscopic procedure had a significant reduction in stress compared to controls [17]. A&#xD;
      similar type of study performed by Hayes et al. (year) revealed that music resulted in a&#xD;
      statistically significant decrease in the State-Trait Anxiety Index (STAI) levels of patients&#xD;
      undergoing an endoscopy [18] . In another study, music was played prior to and during&#xD;
      procedure with no sedative/narcotic medications [19] . Patients with music experienced a&#xD;
      decrease in blood pressure (BP) and RR compared to their counterparts who did not listen to&#xD;
      music. A 3 point attitude scale showed that patients with music had less discomfort,&#xD;
      illustrating that music has the potential to modulate physiological parameters. An&#xD;
      instrumental composition from the album &quot;Nada Himalaya&quot; performed by S.G. Sachchidananda, was&#xD;
      previously studied by Phanishree et al. (unpublished data), which demonstrated a decrease in&#xD;
      the blood pressure and heart rate in patients. Furthermore, the patients were much more&#xD;
      relaxed and calm compared to the beginning of the study. Other music genres have relaxation&#xD;
      properties as well but we wanted to test one specific type of music to see proof of concept&#xD;
      in colonoscopy before we introduce other genres.&#xD;
&#xD;
      Propofol is currently being used more frequently for the use of monitored anesthesia in&#xD;
      surgical settings. Patients on propofol have a better recall that music was being played&#xD;
      compared to general anesthesia, but they could not adequately recall the type of music [20].&#xD;
      Ambient room noise seems to be one of the main factors associated with increasing propofol&#xD;
      requirements in an operation room (OR) which music seems to alleviate [21] . This has been&#xD;
      further illustrated by the use of Bispectral index (BIS), which demonstrated increasing brain&#xD;
      activity when OR decibels were over 50 [22]. With the initiation of music and propofol in the&#xD;
      setting of spinal anesthesia, there was a significant decrease in propofol dose and cortisol&#xD;
      levels intra-op demonstrating the stress relieving effect of music [23,24].&#xD;
&#xD;
      To fully monitor the sedation requirements for patients undergoing colonoscopy two different&#xD;
      scales will be utilized to assess the depth of sedation. The validated University of Michigan&#xD;
      Sedation Scale (UMSS) is a combination of auditory and visual stimuli that are used to assess&#xD;
      the depth of sedation. Since Auditory stimuli can be difficult to assess with the headphones&#xD;
      we will also utilize the Bispectral Index (BIS) to assess the depth of sedation. The BIS&#xD;
      monitor is attached to an electrode that is fixed on the forehead of the patient and&#xD;
      continually assesses the brain activity of the patient. A computer algorithm will assess the&#xD;
      brain activity and gives a value that determines the level of sedation. This in conjunction&#xD;
      with the UMSS scale will give an adequate representation of the depth of sedation. The UMSS&#xD;
      is the standard of care (SOC) in colonoscopy and BIS in general anesthesia.&#xD;
&#xD;
      The UMSS scale:&#xD;
&#xD;
      0 - Awake and alert&#xD;
&#xD;
        1. - Minimally sedated: tired/sleepy, appropriate response to verbal conversation and/or&#xD;
           sound&#xD;
&#xD;
        2. - Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation&#xD;
           or a simple verbal command&#xD;
&#xD;
        3. - Deeply sedated: deep sleep, arousable only with significant physical stimulation&#xD;
&#xD;
        4. - Unarousable&#xD;
&#xD;
      The initial propofol induction dosage is determined by the anesthesiologist and is given&#xD;
      according to the mg/kg requirements. After the induction process the UMSS and BIS scores will&#xD;
      be utilized to determine the amount of propofol to be given as IV pushes to achieve adequate&#xD;
      sedation. Furthermore, the anesthesiologist routinely assesses the American society of&#xD;
      Anesthesiology (ASA) grading system to determine the degree of risk associated with a&#xD;
      procedure with each patient.&#xD;
&#xD;
      The ASA grading system:&#xD;
&#xD;
      Grade 1 Healthy person. Grade 2 Mild systemic disease. Grade 3 Severe systemic disease. Grade&#xD;
      4 Severe systemic disease that is a constant threat to life. Grade 5 A moribund person who is&#xD;
      not expected to survive without the operation. Grade 6 A declared brain dead person whose&#xD;
      organs are being removed for donor purposes.&#xD;
&#xD;
      Research Goals and Objectives This is a prospective single-blinded randomized controlled&#xD;
      trial that will examine the effects of active music participation and music listening on&#xD;
      patients undergoing colonoscopy via propofol (monitored anesthesia) at the Brooklyn Hospital&#xD;
      Center. Our study aims to enroll patients who will undergo colonoscopy and randomize them to&#xD;
      receive either music or no music starting at the time of initial nursing evaluation in the&#xD;
      pre-procedure area. The primary endpoint is to assess the utilization of narcotics/sedatives&#xD;
      during colonoscopy. Secondary endpoints include willingness to repeat the procedure, anxiety&#xD;
      associated with procedure, and association between the year of trainee and the amount of&#xD;
      narcotic/sedatives used in each arm of the study. The complications that occur in reference&#xD;
      of the year of trainee will be observe. We hypothesize that incorporating music during&#xD;
      colonoscopy procedures will alleviate patient discomfort, reduce narcotic/sedative usage and&#xD;
      post-operative complications.&#xD;
&#xD;
      Study Design and Methodology&#xD;
&#xD;
      Design The study design chosen for this study is a prospective single-blinded randomized&#xD;
      control trial as there will be a control group who will not be listening to music and&#xD;
      treatment group. The period study will be conducted for the period of one year.&#xD;
&#xD;
      Study population The study population will include all individuals undergoing colonoscopies&#xD;
      that consented to participating in the study. The study subjects will include the patients&#xD;
      undergoing the procedure and the gastroenterology fellows performing the procedure.&#xD;
&#xD;
      Sample Size Based on a previous study measuring discomfort of patients undergoing colonoscopy&#xD;
      we hypothesized that music can decrease the sedative/narcotic usage by 20 to 25 percent [25].&#xD;
      We expect a difference of 0.32mg/kg difference with a standard deviation of 0.69. Based on&#xD;
      this, with a power of 90% and alpha of 0.05, we need 128 patients per group for a total of&#xD;
      384 patients. We plan to enroll 460 patients (over 18-years of age) to include a 20% dropout&#xD;
      rate due to lack of compliance with headphones, inability to complete the exam, or failure to&#xD;
      finish all accompanied documentation.&#xD;
&#xD;
      Recruitment Methods and Study Sites The study coordinator or investigators at The Brooklyn&#xD;
      Hospital will approach all patients at the time of registration for colonoscopy. The&#xD;
      coordinator will explain the study briefly and if agreeable will be given an iPad with a&#xD;
      prerecorded video explaining the study in detail. After informed consent, patients will be&#xD;
      randomized to either the control group (no music) or music group via a sealed envelope. A&#xD;
      sealed envelope will delineate the particular group the patient will be randomized to. Once&#xD;
      randomized, both groups will fill out a State Trait Anxiety Inventory (STAI) form to&#xD;
      determine the baseline anxiety stress levels (Appendix A). This will be followed by a brief&#xD;
      form (Appendix B) that will determine the type and number of procedures performed in the&#xD;
      past. The forms will be administered in English, Spanish and Polish. Spanish and Polish&#xD;
      translation will be provided using telephone medical translation services at The Brooklyn&#xD;
      Hospital Center.&#xD;
&#xD;
      Data Collection and Storage Confidentiality of research data will be protected in accordance&#xD;
      with the prevailing standards that apply to all clinical data. The binder with the data&#xD;
      collection form and patient information will, as mentioned above, be locked in a filing&#xD;
      cabinet in the GI endoscopy suit and will be reviewed only by the key study personnel. The&#xD;
      patients' electronic health records, which contain the remainder of the patient data, are&#xD;
      password protected. No personal identifying information will be used in any presentation or&#xD;
      publication. The principal investigator and co-investigators will monitor study procedures to&#xD;
      ensure confidentiality of data, safety and proper conduct of the study. Changes to the study&#xD;
      will only occur after IRB amendment approval.&#xD;
&#xD;
      Risks and Benefits Utilizing headphones which can place a slight pressure around the ear,&#xD;
      posing a very minimal risk. There is also a very rare possibility of hearing damage due to&#xD;
      loud music being played on the headphones. To prevent this, the patient will adjust the music&#xD;
      to his or her desired level with audible tones for both groups in the study prior to starting&#xD;
      the music. There is a slight possibility of the loss of confidentiality, however this will be&#xD;
      minimized by keeping all study related materials and data collection forms in a locked file&#xD;
      cabinet as described above. Please refer to the confidentiality section of the protocol.&#xD;
      Breaches of confidentiality, protocol deviations and any adverse events or other problems&#xD;
      that may affect the safety of the subjects will be reported to the IRB in a timely fashion&#xD;
      This study does not involve greater risk to the subjects than what is normally encountered&#xD;
      during the performance of routine physical tests.&#xD;
&#xD;
      The benefit of the study is to demonstrate an overall improvement in sedation and patient&#xD;
      satisfaction while decreasing the total amount of sedatives utilized.&#xD;
&#xD;
      Waiver of HIPAA Informed Consent This is a single blind prospective study that involves&#xD;
      standard of care with human subjects. When not in use by the researchers, the data collection&#xD;
      forms will be kept in a locked file cabinet located in Division of Gastroenterology and&#xD;
      Hepatology, The Brooklyn Hospital Center, 240 Willoughby St., Maynard building, 2nd floor.&#xD;
      Patient's data will be recorded in the computer and will be protected throughout the study in&#xD;
      usual ways for IT security. The data collection form to be used is attached. All patient&#xD;
      identifiers will be de-identified upon completion of data collection.&#xD;
&#xD;
      Resources and Budget The study is not funded and does not require extra lab tests, clinic&#xD;
      visits, or supplies outside of standard clinical care. Therefore, these will not incur any&#xD;
      additional costs for either the patients or the institution. There is no budget associated&#xD;
      with this project as investigators will participate on a volunteer basis. There is no&#xD;
      pay/stipend for study participants. Study personnel are limited to the participating&#xD;
      gastroenterology, internal medicine, and research staff at the Brooklyn Hospital Center. No&#xD;
      expenses will be incurred and nothing will be gained other than normal scholarly gains.&#xD;
&#xD;
      Conclusions Our results will improve patient satisfaction, reduce post-surgery complications&#xD;
      and lessen the anxiety surrounding endoscopic procedures such as colonoscopies. It is our&#xD;
      hope that improving our understanding of the role of music in regards to anxiety related&#xD;
      colonoscopies, through a prospective, randomized, controlled research study, can help better&#xD;
      facilitate patient care and outcomes and serve our population at the Brooklyn Hospital&#xD;
      Center.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 30, 2019</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Amount of sedation used</measure>
    <time_frame>Duration of procedure</time_frame>
    <description>Total dose of propofol will be calculated by the Anesthesiologist's team. The total dosage for each group will be compared using a t-test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety levels and willingness to perform procedures</measure>
    <time_frame>Duration of procedure</time_frame>
    <description>Surveys will be used to assess anxiety levels and willingness to perform procedures. Contingency tables using Pearson's chi-squared test will be used to compare the two groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of music in relation to level of trainee</measure>
    <time_frame>Duration of procedure</time_frame>
    <description>To assess the ordinal data with the year of the trainee using contingency tables and Pearson Chi-squared test</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Colonoscopy</condition>
  <arm_group>
    <arm_group_label>Music</arm_group_label>
    <description>Subjects will put on headphones containing music from the album &quot;Nada Himalaya&quot; performed by S. G. Sachchidananda. The music will start playing 10 minutes before the colonoscopy procedure and will stop once subjects have woken up from sedation. Subjects will be instructed to not tell anyone if music is playing from their headphones. Subjects will two questionnaires before the procedure asking about their initial anxiety levels and previous procedure history. Two questionnaires following the procedure will be provide asking about their anxiety levels following the procedure and their overall satisfaction with the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Subjects will put on headphones, but there will be no music playing. Subjects are instructed to not tell anyone if music is playing from their headphones. Subjects will two questionnaires before the procedure asking about their initial anxiety levels and previous procedure history. Two questionnaires following the procedure will be provide asking about their anxiety levels following the procedure and their overall satisfaction with the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music: &quot;Nada Himalaya&quot; performed by S. G. Sachchidananda</intervention_name>
    <description>Music: &quot;Nada Himalaya&quot; performed by S. G. Sachchidananda</description>
    <arm_group_label>Music</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include all individuals undergoing colonoscopies that consented&#xD;
        to participating in the study. The study subjects will include the patients undergoing the&#xD;
        procedure and the gastroenterology fellows performing the procedure.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anyone scheduled for in-patient colonoscopy&#xD;
&#xD;
          -  Must be able to speak English, Spanish, or Polish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hearing impairment&#xD;
&#xD;
          -  Mentally challenged&#xD;
&#xD;
          -  Previous resection of the colon&#xD;
&#xD;
          -  Currently using narcotics or sedative medications&#xD;
&#xD;
          -  If patient is unwilling to use headphones after consenting&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Krishna Gurram, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Brooklyn Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daryl Ramai, MD, MScBR</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Brooklyn Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khoi Paul Dang-Ho</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Brooklyn Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Madhavi Reddy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Brooklyn Hospital Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Denzil Etienne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Brooklyn Hospital Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Brooklyn Hospital Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  </reference>
  <reference>
    <citation>Kim DW, Kil HY, White PF. The effect of noise on the bispectral index during propofol sedation. Anesth Analg. 2001 Nov;93(5):1170-3. doi: 10.1097/00000539-200111000-00022.</citation>
    <PMID>11682389</PMID>
  </reference>
  <reference>
    <citation>Koelsch S, Fuermetz J, Sack U, Bauer K, Hohenadel M, Wiegel M, Kaisers UX, Heinke W. Effects of Music Listening on Cortisol Levels and Propofol Consumption during Spinal Anesthesia. Front Psychol. 2011 Apr 5;2:58. doi: 10.3389/fpsyg.2011.00058. eCollection 2011.</citation>
    <PMID>21716581</PMID>
  </reference>
  <reference>
    <citation>Lee DW, Chan KW, Poon CM, Ko CW, Chan KH, Sin KS, Sze TS, Chan AC. Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Jan;55(1):33-6. doi: 10.1067/mge.2002.120387.</citation>
    <PMID>11756911</PMID>
  </reference>
  <reference>
    <citation>Zhang 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.</citation>
    <PMID>16179044</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Colonoscopy</keyword>
  <keyword>Music</keyword>
  <keyword>Propofol</keyword>
  <keyword>Conscious Sedation</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468048
org study id: 1309407-1
nct id: NCT04468048
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Conscious sedation (CS) if often used in the field of gastroenterology to alleviate pain and
      discomfort with interventional procedures. Although CS is relatively safe, there is concern
      for the development of cardiopulmonary complications. Music has been shown in multiple
      studies to decrease anxiety and improve patient satisfaction following cardiac, pulmonary,
      and surgical procedures. This is a prospective single-blinded randomized control trial that
      will examine the effects of active music participation and music listening on patients
      undergoing colonoscopy through propofol use (monitored anesthesia) at The Brooklyn Hospital
      Center. The study will enroll patients who will undergo colonoscopy from November 2018 to
      April 2019 and randomize them to receive music or no music starting at the initial nursing
      evaluation in the pre-procedure area. We hypothesize that incorporating music during
      colonoscopy procedures will alleviate patient discomfort, reduce narcotic/sedative usage and
      post-operative complications.
Introduction Conscious sedation (CS) in the field of gastroenterology is commonly
      incorporated in order to alleviate pain and discomfort associated with interventional
      procedures. The use of CS to combat patient anxiety has been well documented [1]. Although CS
      is relatively safe, it is not immune to cardiopulmonary complications. Multiple studies have
      demonstrated a clear correlation between advancing age and procedure related complications
      [2-4]. It is also important to note that despite the lack of association between age and
      additional complications in a study conducted by Clarke et al, a third of their patients did
      not receive sedation/narcotic medications [5].

      Obesity, which affects approximately two third of the U.S. population, has a myriad of health
      related risks and has been shown to contribute to the overall complications associated with
      endoscopic procedures [6]. Because those who are obese and overweight have higher than normal
      BMIs, BMI should not be ignored when assessing cardiopulmonary complications in patients
      undergoing endoscopic procedures. Moreover, a study by Qadeer et al. revealed that patients
      with high BMIs were more likely to experience hypoxic episodes [3].

      A study by Sharma et al. (2007) looked at more than 300,000 patients who underwent endoscopic
      procedures while monitoring their risk factors for cardiopulmonary complications [4]. Older
      age, American Society of Anesthesia (ASA) grade value >2, inpatient procedures, and
      involvement of trainee with procedure were all shown to be associated with cardiopulmonary
      complications. In addition, another study by Bini et al.(2003) illustrated that the age of a
      patient, comorbid conditions, month of procedure (July and August), and midazolam dose were
      linked with increased negative outcomes [2]. The correlation between complication rate during
      procedures along with the year of the trainee conducting the procedure indirectly
      demonstrated the complications in the new academic year (July and August). Understanding that
      sedation during endoscopic procedures incurs significant risks particularly in patients who
      are underweight, obese or have numerous comorbidities can lead to steps aimed at better
      managing the aforementioned risks and reducing patient discomfort.

      Music has been shown in many studies to decrease anxiety and improve patient satisfaction
      during and after procedures in cardiac, pulmonary and surgical procedures [7-16]. In regards
      to endoscopies, one hundred and eighty patients who were listening to music prior to
      endoscopic procedure had a significant reduction in stress compared to controls [17]. A
      similar type of study performed by Hayes et al. (year) revealed that music resulted in a
      statistically significant decrease in the State-Trait Anxiety Index (STAI) levels of patients
      undergoing an endoscopy [18] . In another study, music was played prior to and during
      procedure with no sedative/narcotic medications [19] . Patients with music experienced a
      decrease in blood pressure (BP) and RR compared to their counterparts who did not listen to
      music. A 3 point attitude scale showed that patients with music had less discomfort,
      illustrating that music has the potential to modulate physiological parameters. An
      instrumental composition from the album "Nada Himalaya" performed by S.G. Sachchidananda, was
      previously studied by Phanishree et al. (unpublished data), which demonstrated a decrease in
      the blood pressure and heart rate in patients. Furthermore, the patients were much more
      relaxed and calm compared to the beginning of the study. Other music genres have relaxation
      properties as well but we wanted to test one specific type of music to see proof of concept
      in colonoscopy before we introduce other genres.

      Propofol is currently being used more frequently for the use of monitored anesthesia in
      surgical settings. Patients on propofol have a better recall that music was being played
      compared to general anesthesia, but they could not adequately recall the type of music [20].
      Ambient room noise seems to be one of the main factors associated with increasing propofol
      requirements in an operation room (OR) which music seems to alleviate [21] . This has been
      further illustrated by the use of Bispectral index (BIS), which demonstrated increasing brain
      activity when OR decibels were over 50 [22]. With the initiation of music and propofol in the
      setting of spinal anesthesia, there was a significant decrease in propofol dose and cortisol
      levels intra-op demonstrating the stress relieving effect of music [23,24].

      To fully monitor the sedation requirements for patients undergoing colonoscopy two different
      scales will be utilized to assess the depth of sedation. The validated University of Michigan
      Sedation Scale (UMSS) is a combination of auditory and visual stimuli that are used to assess
      the depth of sedation. Since Auditory stimuli can be difficult to assess with the headphones
      we will also utilize the Bispectral Index (BIS) to assess the depth of sedation. The BIS
      monitor is attached to an electrode that is fixed on the forehead of the patient and
      continually assesses the brain activity of the patient. A computer algorithm will assess the
      brain activity and gives a value that determines the level of sedation. This in conjunction
      with the UMSS scale will give an adequate representation of the depth of sedation. The UMSS
      is the standard of care (SOC) in colonoscopy and BIS in general anesthesia.

      The UMSS scale:

      0 - Awake and alert

        1. - Minimally sedated: tired/sleepy, appropriate response to verbal conversation and/or
           sound

        2. - Moderately sedated: somnolent/sleeping, easily aroused with light tactile stimulation
           or a simple verbal command

        3. - Deeply sedated: deep sleep, arousable only with significant physical stimulation

        4. - Unarousable

      The initial propofol induction dosage is determined by the anesthesiologist and is given
      according to the mg/kg requirements. After the induction process the UMSS and BIS scores will
      be utilized to determine the amount of propofol to be given as IV pushes to achieve adequate
      sedation. Furthermore, the anesthesiologist routinely assesses the American society of
      Anesthesiology (ASA) grading system to determine the degree of risk associated with a
      procedure with each patient.

      The ASA grading system:

      Grade 1 Healthy person. Grade 2 Mild systemic disease. Grade 3 Severe systemic disease. Grade
      4 Severe systemic disease that is a constant threat to life. Grade 5 A moribund person who is
      not expected to survive without the operation. Grade 6 A declared brain dead person whose
      organs are being removed for donor purposes.

      Research Goals and Objectives This is a prospective single-blinded randomized controlled
      trial that will examine the effects of active music participation and music listening on
      patients undergoing colonoscopy via propofol (monitored anesthesia) at the Brooklyn Hospital
      Center. Our study aims to enroll patients who will undergo colonoscopy and randomize them to
      receive either music or no music starting at the time of initial nursing evaluation in the
      pre-procedure area. The primary endpoint is to assess the utilization of narcotics/sedatives
      during colonoscopy. Secondary endpoints include willingness to repeat the procedure, anxiety
      associated with procedure, and association between the year of trainee and the amount of
      narcotic/sedatives used in each arm of the study. The complications that occur in reference
      of the year of trainee will be observe. We hypothesize that incorporating music during
      colonoscopy procedures will alleviate patient discomfort, reduce narcotic/sedative usage and
      post-operative complications.

      Study Design and Methodology

      Design The study design chosen for this study is a prospective single-blinded randomized
      control trial as there will be a control group who will not be listening to music and
      treatment group. The period study will be conducted for the period of one year.

      Study population The study population will include all individuals undergoing colonoscopies
      that consented to participating in the study. The study subjects will include the patients
      undergoing the procedure and the gastroenterology fellows performing the procedure.

      Sample Size Based on a previous study measuring discomfort of patients undergoing colonoscopy
      we hypothesized that music can decrease the sedative/narcotic usage by 20 to 25 percent [25].
      We expect a difference of 0.32mg/kg difference with a standard deviation of 0.69. Based on
      this, with a power of 90% and alpha of 0.05, we need 128 patients per group for a total of
      384 patients. We plan to enroll 460 patients (over 18-years of age) to include a 20% dropout
      rate due to lack of compliance with headphones, inability to complete the exam, or failure to
      finish all accompanied documentation.

      Recruitment Methods and Study Sites The study coordinator or investigators at The Brooklyn
      Hospital will approach all patients at the time of registration for colonoscopy. The
      coordinator will explain the study briefly and if agreeable will be given an iPad with a
      prerecorded video explaining the study in detail. After informed consent, patients will be
      randomized to either the control group (no music) or music group via a sealed envelope. A
      sealed envelope will delineate the particular group the patient will be randomized to. Once
      randomized, both groups will fill out a State Trait Anxiety Inventory (STAI) form to
      determine the baseline anxiety stress levels (Appendix A). This will be followed by a brief
      form (Appendix B) that will determine the type and number of procedures performed in the
      past. The forms will be administered in English, Spanish and Polish. Spanish and Polish
      translation will be provided using telephone medical translation services at The Brooklyn
      Hospital Center.

      Data Collection and Storage Confidentiality of research data will be protected in accordance
      with the prevailing standards that apply to all clinical data. The binder with the data
      collection form and patient information will, as mentioned above, be locked in a filing
      cabinet in the GI endoscopy suit and will be reviewed only by the key study personnel. The
      patients' electronic health records, which contain the remainder of the patient data, are
      password protected. No personal identifying information will be used in any presentation or
      publication. The principal investigator and co-investigators will monitor study procedures to
      ensure confidentiality of data, safety and proper conduct of the study. Changes to the study
      will only occur after IRB amendment approval.

      Risks and Benefits Utilizing headphones which can place a slight pressure around the ear,
      posing a very minimal risk. There is also a very rare possibility of hearing damage due to
      loud music being played on the headphones. To prevent this, the patient will adjust the music
      to his or her desired level with audible tones for both groups in the study prior to starting
      the music. There is a slight possibility of the loss of confidentiality, however this will be
      minimized by keeping all study related materials and data collection forms in a locked file
      cabinet as described above. Please refer to the confidentiality section of the protocol.
      Breaches of confidentiality, protocol deviations and any adverse events or other problems
      that may affect the safety of the subjects will be reported to the IRB in a timely fashion
      This study does not involve greater risk to the subjects than what is normally encountered
      during the performance of routine physical tests.

      The benefit of the study is to demonstrate an overall improvement in sedation and patient
      satisfaction while decreasing the total amount of sedatives utilized.

      Waiver of HIPAA Informed Consent This is a single blind prospective study that involves
      standard of care with human subjects. When not in use by the researchers, the data collection
      forms will be kept in a locked file cabinet located in Division of Gastroenterology and
      Hepatology, The Brooklyn Hospital Center, 240 Willoughby St., Maynard building, 2nd floor.
      Patient's data will be recorded in the computer and will be protected throughout the study in
      usual ways for IT security. The data collection form to be used is attached. All patient
      identifiers will be de-identified upon completion of data collection.

      Resources and Budget The study is not funded and does not require extra lab tests, clinic
      visits, or supplies outside of standard clinical care. Therefore, these will not incur any
      additional costs for either the patients or the institution. There is no budget associated
      with this project as investigators will participate on a volunteer basis. There is no
      pay/stipend for study participants. Study personnel are limited to the participating
      gastroenterology, internal medicine, and research staff at the Brooklyn Hospital Center. No
      expenses will be incurred and nothing will be gained other than normal scholarly gains.

      Conclusions Our results will improve patient satisfaction, reduce post-surgery complications
      and lessen the anxiety surrounding endoscopic procedures such as colonoscopies. It is our
      hope that improving our understanding of the role of music in regards to anxiety related
      colonoscopies, through a prospective, randomized, controlled research study, can help better
      facilitate patient care and outcomes and serve our population at the Brooklyn Hospital
      Center.
observational model: Cohort
time perspective: Prospective
measure: Amount of sedation used
time frame: Duration of procedure
description: Total dose of propofol will be calculated by the Anesthesiologist's team. The total dosage for each group will be compared using a t-test
measure: Anxiety levels and willingness to perform procedures
time frame: Duration of procedure
description: Surveys will be used to assess anxiety levels and willingness to perform procedures. Contingency tables using Pearson's chi-squared test will be used to compare the two groups.
measure: Effect of music in relation to level of trainee
time frame: Duration of procedure
description: To assess the ordinal data with the year of the trainee using contingency tables and Pearson Chi-squared test
arm group label: Music
description: Subjects will put on headphones containing music from the album "Nada Himalaya" performed by S. G. Sachchidananda. The music will start playing 10 minutes before the colonoscopy procedure and will stop once subjects have woken up from sedation. Subjects will be instructed to not tell anyone if music is playing from their headphones. Subjects will two questionnaires before the procedure asking about their initial anxiety levels and previous procedure history. Two questionnaires following the procedure will be provide asking about their anxiety levels following the procedure and their overall satisfaction with the procedure.
arm group label: Control
description: Subjects will put on headphones, but there will be no music playing. Subjects are instructed to not tell anyone if music is playing from their headphones. Subjects will two questionnaires before the procedure asking about their initial anxiety levels and previous procedure history. Two questionnaires following the procedure will be provide asking about their anxiety levels following the procedure and their overall satisfaction with the procedure.
intervention type: Other
intervention name: Music: "Nada Himalaya" performed by S. G. Sachchidananda
description: Music: "Nada Himalaya" performed by S. G. Sachchidananda
arm group label: Music
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Krishna Gurram, MD
role: Principal Investigator
affiliation: The Brooklyn Hospital Center
last name: Daryl Ramai, MD, MScBR
role: Principal Investigator
affiliation: The Brooklyn Hospital Center
last name: Khoi Paul Dang-Ho
role: Principal Investigator
affiliation: The Brooklyn Hospital Center
last name: Madhavi Reddy, MD
role: Principal Investigator
affiliation: The Brooklyn Hospital Center
last name: Denzil Etienne, MD
role: Principal Investigator
affiliation: The Brooklyn Hospital Center
facility: 
country: United States
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PMID: 19604181
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PMID: 12920428
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PMID: 8424291
citation: Ayoub CM, Rizk LB, Yaacoub CI, Gaal D, Kain ZN. Music and ambient operating room noise in patients undergoing spinal anesthesia. Anesth Analg. 2005 May;100(5):1316-1319. doi: 10.1213/01.ANE.0000153014.46893.9B.
PMID: 15845676
citation: Kim DW, Kil HY, White PF. The effect of noise on the bispectral index during propofol sedation. Anesth Analg. 2001 Nov;93(5):1170-3. doi: 10.1097/00000539-200111000-00022.
PMID: 11682389
citation: Koelsch S, Fuermetz J, Sack U, Bauer K, Hohenadel M, Wiegel M, Kaisers UX, Heinke W. Effects of Music Listening on Cortisol Levels and Propofol Consumption during Spinal Anesthesia. Front Psychol. 2011 Apr 5;2:58. doi: 10.3389/fpsyg.2011.00058. eCollection 2011.
PMID: 21716581
citation: Lee DW, Chan KW, Poon CM, Ko CW, Chan KH, Sin KS, Sze TS, Chan AC. Relaxation music decreases the dose of patient-controlled sedation during colonoscopy: a prospective randomized controlled trial. Gastrointest Endosc. 2002 Jan;55(1):33-6. doi: 10.1067/mge.2002.120387.
PMID: 11756911
citation: Zhang 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.
PMID: 16179044
responsible party type: Sponsor
sharing ipd: Undecided