<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/NCT04485650</url>
  </required_header>
  <id_info>
    <org_study_id>AIBU-AML-UY-01</org_study_id>
    <nct_id>NCT04485650</nct_id>
  </id_info>
  <brief_title>Effect of Music in Intraoperative Period</brief_title>
  <official_title>The Effect of Music Therapy on Postoperative Pain Anxiety and Vital Signs in Patients Undergoing Spinal Anaesthesia: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abant Izzet Baysal University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abant Izzet Baysal University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and Aims: Music therapy has a wide range of uses in health care practice. The aim&#xD;
      of this study was to investigate the effects of intraoperative music played during spinal&#xD;
      anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and&#xD;
      anxiety status.&#xD;
&#xD;
      Methods: The study was performed in an operating room with a total of 90 patients, of whom 30&#xD;
      were in the music group, 30 were in the control group and 30 were in the sedated group. The&#xD;
      ethics committee's approval, institutional permission, and the study participants' written&#xD;
      informed consent were obtained. Data were collected using patient information and&#xD;
      intraoperative observation form for vital signs as well as through the Visual Analog Scale&#xD;
      and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and&#xD;
      postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 24, 2017</start_date>
  <completion_date type="Actual">May 30, 2017</completion_date>
  <primary_completion_date type="Actual">March 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>In the study, 30 patients were assigned to the music group, 30 patients were assigned to the group that received sedation and 30 patients were assigned to a group that was not sedated, all occurred in a randomized controlled way.&#xD;
The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. Sedation (Dormicum) was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The patients in the non-sedated group were followed without any procedure (sedation and music).</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</measure>
    <time_frame>Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative</time_frame>
    <description>Measurement of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</measure>
    <time_frame>Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative</time_frame>
    <description>Measurement of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</measure>
    <time_frame>Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative</time_frame>
    <description>Measurement of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</measure>
    <time_frame>Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative</time_frame>
    <description>Measurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anxiety assessment 30 minutes before surgery</measure>
    <time_frame>State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery</time_frame>
    <description>State- Trait Anxiety Scale was applied to all three groups in preoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>anxiety assessment 8 hours after surgery</measure>
    <time_frame>State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery</time_frame>
    <description>State- Trait Anxiety Scale was applied to all three groups in postoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain assessment in the operating room</measure>
    <time_frame>The pain was assessed at the end of the operation in 10 minutes with numerical pain scale</time_frame>
    <description>The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain at 1 hours</measure>
    <time_frame>The pain was assessed followed at 1 hours postoperative period with numerical pain scale</time_frame>
    <description>The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain at 8 hours</measure>
    <time_frame>The pain was assessed followed at 8 hours postoperative period with numerical pain scale</time_frame>
    <description>The pain was assessed with numerical pain. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Music Therapy</condition>
  <condition>Perioperative Care</condition>
  <condition>Postoperative Pain</condition>
  <condition>Anxiety</condition>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Vital Signs</condition>
  <condition>Spinal Anesthesia</condition>
  <arm_group>
    <arm_group_label>Music group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. The number of participants:30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sedated group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-sedated group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>music therapy</intervention_name>
    <description>The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group.</description>
    <arm_group_label>Music group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sedated group</intervention_name>
    <description>Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30</description>
    <arm_group_label>Sedated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>non-sedated group</intervention_name>
    <description>The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30</description>
    <arm_group_label>Non-sedated group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients that had an orthopedic operation&#xD;
&#xD;
          -  The patients who took spinal anesthesia&#xD;
&#xD;
          -  able to understand, read and speak Turkish, so they may complete the informed consent&#xD;
             and questionaires&#xD;
&#xD;
          -  Aged 18 or older&#xD;
&#xD;
          -  Have a Body Mass Index (BMI) &lt;40&#xD;
&#xD;
          -  ASA (American Society of Anaesthesiologists) I-II-III statuses.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with vision and hearing problems and inability to complete questionnaires,&#xD;
&#xD;
          -  The patients not have psychiatric disease history and psychiatric drug use,&#xD;
&#xD;
          -  The patients not have diseases that could be evaluated as severe (such as heart,&#xD;
             kidney, liver failure)&#xD;
&#xD;
          -  The patients not underwent emergency surgeries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ümmühan yiğit, msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>research assistant</affiliation>
  </overall_official>
  <overall_official>
    <last_name>arzu ilçe, proffesor</last_name>
    <role>Principal Investigator</role>
    <affiliation>faculty of health science of dean</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ibrahim karagöz, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>anesthesiology and reanimation doctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of health sciences</name>
      <address>
        <city>Bolu</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Koc H, Erk G, Apaydin Y, Horasanli E, Yigitbasi B, Dikmen B. The Effects of Classical Turkish Music on Patients Undergoing Inguinal Hernia Repair under Epidural Anesthesia. Turk Anaesth Int Care. 2009;37:366-373.</citation>
  </reference>
  <reference>
    <citation>Sener EB, Koylu N, Ustun FE, Kocamanoglu S, Ozkan F. The effects of music, white noise and operating room noise on perioperative anxiety in patients under spinal anesthesia. European Journal Of Anaesthesiology (EJA). 2010;24:133</citation>
  </reference>
  <reference>
    <citation>Uyar M, Akin Korhan E. [The effect of music therapy on pain and anxiety in intensive care patients]. Agri. 2011 Oct;23(4):139-46. doi: 10.5505/agri.2011.94695. Turkish.</citation>
    <PMID>22290677</PMID>
  </reference>
  <reference>
    <citation>Bansal P, Kharrod U, Sanwatsarkar S, Patel H, Kamat H. The Effect Of Music Therapy On Sedative Requirements And Haemodynamic Parameters In Patients Under Spinal Anaesthesia; A Prospective Study. Journal Of Clinical And Diagnostic Research. 2010;4:2782-2789.</citation>
  </reference>
  <reference>
    <citation>Liu Y, Petrini MA. Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. Complement Ther Med. 2015 Oct;23(5):714-8. doi: 10.1016/j.ctim.2015.08.002. Epub 2015 Aug 4.</citation>
    <PMID>26365452</PMID>
  </reference>
  <reference>
    <citation>Allen K, Golden LH, Izzo JL Jr, Ching MI, Forrest A, Niles CR, Niswander PR, Barlow JC. Normalization of hypertensive responses during ambulatory surgical stress by perioperative music. Psychosom Med. 2001 May-Jun;63(3):487-92. doi: 10.1097/00006842-200105000-00019.</citation>
    <PMID>11382277</PMID>
  </reference>
  <reference>
    <citation>Bae I, Lim HM, Hur MH, Lee M. Intra-operative music listening for anxiety, the BIS index, and the vital signs of patients undergoing regional anesthesia. Complement Ther Med. 2014 Apr;22(2):251-7. doi: 10.1016/j.ctim.2014.02.002. Epub 2014 Feb 23.</citation>
    <PMID>24731896</PMID>
  </reference>
  <reference>
    <citation>Komurcu E, Kiraz HA, Kaymaz B, Golge UH, Nusran G, Goksel F, Sahin H, Omur D, Hanci V. The effect of intraoperative sounds of saw and hammer on psychological condition in patients with total knee arthroplasty: prospective randomized study. ScientificWorldJournal. 2015;2015:690569. doi: 10.1155/2015/690569. Epub 2015 Feb 22.</citation>
    <PMID>25793222</PMID>
  </reference>
  <reference>
    <citation>Sarkar D, Chakraborty K, Bhadra B, Ghorai TK, Singh R, Mandal U. Effects of music on patients undergoing orthopaedic surgery under spinal anaesthesia. IOSR Journal of Dental and Medical Sciences. 2015;14:2279-2861.</citation>
  </reference>
  <reference>
    <citation>Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.</citation>
    <PMID>16741859</PMID>
  </reference>
  <reference>
    <citation>Bailey L. Strategies for decreasing patient anxiety in the perioperative setting. AORN J. 2010 Oct;92(4):445-57; quiz 458-60. doi: 10.1016/j.aorn.2010.04.017. Erratum In: AORN J. 2010 Dec;92(6):708.</citation>
    <PMID>20888947</PMID>
  </reference>
  <reference>
    <citation>Boker A, Brownell L, Donen N. The Amsterdam preoperative anxiety and information scale provides a simple and reliable measure of preoperative anxiety. Can J Anaesth. 2002 Oct;49(8):792-8. doi: 10.1007/BF03017410.</citation>
    <PMID>12374706</PMID>
  </reference>
  <reference>
    <citation>Carr E, Brockbank K, Allen S, Strike P. Patterns and frequency of anxiety in women undergoing gynaecological surgery. J Clin Nurs. 2006 Mar;15(3):341-52. doi: 10.1111/j.1365-2702.2006.01285.x.</citation>
    <PMID>16466484</PMID>
  </reference>
  <reference>
    <citation>Gursoy A A. Anxiety Levels of Preoperative Patients and Determining the Factors That May Cause Anxiety. Journal of Nursing Research. 2001;1:23-29.</citation>
  </reference>
  <reference>
    <citation>Turhan Y, Avci R, Ozcengiz D. The Relationship Between Preoperative And Postoperative Anxiety, And Patient Satisfaction In Preparation For Elective Surgery. Journal of Anesthesia. 2012;20:27-33</citation>
  </reference>
  <reference>
    <citation>Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict postoperative pain? AORN J. 2007 Mar;85(3):589-604. doi: 10.1016/S0001-2092(07)60130-6.</citation>
    <PMID>17352896</PMID>
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    <citation>Yilmaz E, Aydin E. The Effect of Pre and Postoperative Anxiety in Quality of Recovery in Patients Undergoing Surgery. Fırat Health Services Journal. 2013;8:79-95.</citation>
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    <citation>Eti Aslan F. The assessment methods of pain. Journal of Cumhuriyet University School of Nursing. 2002;6:9-16.</citation>
  </reference>
  <reference>
    <citation>Shek DT. The Chinese version of the State-Trait Anxiety Inventory: its relationship to different measures of psychological well-being. J Clin Psychol. 1993 May;49(3):349-58. doi: 10.1002/1097-4679(199305)49:33.0.co;2-j.</citation>
    <PMID>8315037</PMID>
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    <citation>Lepage C, Drolet P, Girard M, Grenier Y, DeGagne R. Music decreases sedative requirements during spinal anesthesia. Anesth Analg. 2001 Oct;93(4):912-6. doi: 10.1097/00000539-200110000-00022.</citation>
    <PMID>11574356</PMID>
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    <citation>Zhu NN, Xu PP, Lei TT, Sun T, Chan SW. Postoperative Pain Self-Management Behavior in Patients Who Underwent Total Knee or Hip Arthroplasty. AORN J. 2017 Apr;105(4):355-364. doi: 10.1016/j.aorn.2017.02.001.</citation>
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    <citation>Chen HJ, Chen TY, Huang CY, Hsieh YM, Lai HL. Effects of music on psychophysiological responses and opioid dosage in patients undergoing total knee replacement surgery. Jpn J Nurs Sci. 2015 Oct;12(4):309-19. doi: 10.1111/jjns.12070. Epub 2015 Mar 9.</citation>
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    <citation>Sendelbach SE, Halm MA, Doran KA, Miller EH, Gaillard P. Effects of music therapy on physiological and psychological outcomes for patients undergoing cardiac surgery. J Cardiovasc Nurs. 2006 May-Jun;21(3):194-200. doi: 10.1097/00005082-200605000-00007.</citation>
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    <citation>Jimenez-Jimenez M, Garcia-Escalona A, Martin-Lopez A, De Vera-Vera R, De Haro J. Intraoperative stress and anxiety reduction with music therapy: a controlled randomized clinical trial of efficacy and safety. J Vasc Nurs. 2013 Sep;31(3):101-6. doi: 10.1016/j.jvn.2012.10.002.</citation>
    <PMID>23953858</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>April 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>music therapy</keyword>
  <keyword>perioperative care</keyword>
  <keyword>postoperative pain</keyword>
  <keyword>anxiety</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>vital signs</keyword>
  <keyword>spinal aesthesia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>when the planned number of participants was reached, the data were coded in a statistical program and shared with other researchers</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT04485650/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04485650
org study id: AIBU-AML-UY-01
nct id: NCT04485650
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background and Aims: Music therapy has a wide range of uses in health care practice. The aim
      of this study was to investigate the effects of intraoperative music played during spinal
      anesthesia operation on the patients' intraoperative vital signs, postoperative pain, and
      anxiety status.

      Methods: The study was performed in an operating room with a total of 90 patients, of whom 30
      were in the music group, 30 were in the control group and 30 were in the sedated group. The
      ethics committee's approval, institutional permission, and the study participants' written
      informed consent were obtained. Data were collected using patient information and
      intraoperative observation form for vital signs as well as through the Visual Analog Scale
      and State Anxiety Scale. Preoperative and postoperative anxiety, the intraoperative and
      postoperative vital signs and postoperative pain and anxiety of all groups were analyzed.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: In the study, 30 patients were assigned to the music group, 30 patients were assigned to the group that received sedation and 30 patients were assigned to a group that was not sedated, all occurred in a randomized controlled way.
The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. Sedation (Dormicum) was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The patients in the non-sedated group were followed without any procedure (sedation and music).
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Distribution of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
time frame: Change from Baseline Systolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
description: Measurement of systolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
measure: Distribution of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
time frame: Change from Baselinebdiastolic Blood Pressure on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
description: Measurement of diastolic blood pressure of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
measure: Distribution of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
time frame: Change from Baseline pulse rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
description: Measurement of pulse rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
measure: Distribution of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
time frame: Change from Baseline of patients respiratory rates on intraoperative 5 minutes to 2 hours ; postoperative 10 minutes to 2 hours postoperative
description: Measurement of respiratory rates of patients in the sedated, music and control groups in intraoperative and postoperative period follow-ups
measure: anxiety assessment 30 minutes before surgery
time frame: State- Trait Anxiety Scale was applied to all three groups in 30 minutes before surgery
description: State- Trait Anxiety Scale was applied to all three groups in preoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
measure: anxiety assessment 8 hours after surgery
time frame: State- Trait Anxiety Scale was applied to all three groups in 8 hours after surgery
description: State- Trait Anxiety Scale was applied to all three groups in postoperative period.Distribution of preoperative and postoperative state anxiety scores according to groups. State- Trait Anxiety Scale: This scale was developed by Spielberger et al. in 1970 to determine the level of the individual anxiety state. It has 40 items in two constructs of state and trait. Since state anxiety scale was emphasized in the present study, only 20-item state scale construct was used. Each item had a 4-point Likert scale answer, from 1 (almost never) to 4 (almost always), and the possible total score ranged from 20 (the lowest level of anxiety) to 80 (the highest level of anxiety)
measure: pain assessment in the operating room
time frame: The pain was assessed at the end of the operation in 10 minutes with numerical pain scale
description: The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain
measure: Postoperative pain at 1 hours
time frame: The pain was assessed followed at 1 hours postoperative period with numerical pain scale
description: The pain was assessed with numerical pain scale. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0) and ends at the level of unbearable pain.
measure: Postoperative pain at 8 hours
time frame: The pain was assessed followed at 8 hours postoperative period with numerical pain scale
description: The pain was assessed with numerical pain. Numerical Pain Scale: It is used by the patient himself/herself to assess and measure severity of the pain. The scale begins with the absence of pain (0)
arm group label: Music group
arm group type: Experimental
description: The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group. The number of participants:30
arm group label: Sedated group
arm group type: Active Comparator
description: Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30
arm group label: Non-sedated group
arm group type: Other
description: The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30
intervention type: Other
intervention name: music therapy
description: The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group.
arm group label: Music group
intervention type: Other
intervention name: sedated group
description: Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30
arm group label: Sedated group
intervention type: Other
intervention name: non-sedated group
description: The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30
arm group label: Non-sedated group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: ümmühan yiğit, msc
role: Principal Investigator
affiliation: research assistant
last name: arzu ilçe, proffesor
role: Principal Investigator
affiliation: faculty of health science of dean
last name: ibrahim karagöz, phd
role: Principal Investigator
affiliation: anesthesiology and reanimation doctor
facility: 
country: Turkey
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PMID: 22290677
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responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Anxiety Disorders
sharing ipd: No
ipd description: when the planned number of participants was reached, the data were coded in a statistical program and shared with other researchers
provided document: 