xml: <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/NCT05982184</url>
    </required_header>
    <id_info>
      <org_study_id>9411</org_study_id>
      <nct_id>NCT05982184</nct_id>
    </id_info>
    <brief_title>Effect of Music Prehabilitation on Preoperative Anxiety Before Surgery</brief_title>
    <acronym>MU-PRIOR</acronym>
    <official_title>Effect of Music Prehabilitation on Preoperative Anxiety in Patients Undergoing Colorectal Oncological Resection: a Multicentre Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Erasmus Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Erasmus Medical Center</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>
        The goal of this multicenter randomized controlled trial is to investigate the effect of&#xD;
        music prehabilitation on preoperative anxiety in patients undergoing elective oncological&#xD;
        colorectal resection. Patients will be asked to listen to music three times a day starting&#xD;
        one week before day of surgery. Anxiety levels will be compared with the control group that&#xD;
        is not explicitly instructed to listen to music by using validated questionnaires&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Perioperative music interventions have been proven to have a positive effect on surgical&#xD;
        patients regarding postoperative pain, anxiety and stress. Preoperative anxiety is a&#xD;
        predictor for postoperative pain. It is hypothesized that preoperative anxiety develops at&#xD;
        home. Unfortunately, data on this subject is scarce. Prehabilitation is a relatively new&#xD;
        concept, which improves the patient's condition at home waiting for a surgical intervention.&#xD;
        No studies exist in which music is implemented as a prehabilitation method. Music&#xD;
        interventions are relatively simple low cost, sustainable and know no side effects. The&#xD;
        researchers hypothesize that the use of pre-admittance music interventions as a&#xD;
        prehabilitation modality in oncological colorectal surgical patients will decrease&#xD;
        preoperative anxiety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.</measure>
      <time_frame>Baseline and day of admittance to hospital</time_frame>
      <description>The STAI-6 questionnaire is a validated and frequently used six item questionnaire to assess anxiety. Six questions regarding feelings of anxiety are scored on a four point Likert scale. Scoring is achieved by reverse scoring of the positive items, sum all six scores, and multiplying the score by 20 divided by 6. The score ranges between 20 and 80, in which a higher score correlates with a higher anxiety level.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient reported pain on a 1-10 numeric scale.</measure>
      <time_frame>Thrice daily on each post-operative day until discharge</time_frame>
      <description>Pain scores are gathered thrice daily by nurses as part of standard care</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of delirium diagnosis made by geriatricians or psychiatrists</measure>
      <time_frame>Post-operative until discharge</time_frame>
      <description>Diagnosis of delirium by geriatricians or psychiatrists as noted in the electronic health report were considered as a confirmed diagnosis of delirium</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delirium observation scale scores (DOS).</measure>
      <time_frame>Post-operative until discharge</time_frame>
      <description>The DOS is a 13-point screen for delirium, based on Diagnostic and statistical manual of mental disorders version 4 (DSM-IV) delirium criteria, designed to be completed by a nurse. Responses are dichotomous. Scores ≥ 3 were considered positive delirium screens.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.</measure>
      <time_frame>Baseline, day of admittance and discharge</time_frame>
      <description>The PSS-10 is a validated questionnaire which assess subjective stress. It is a 10-item, comprehensive, reliable and valid instrument which is created and validated in the American population and widely used in medical/psychological studies. The items are each scored on a five-point Likert scale (ranging from 0 = never to 4 = very often). A Dutch translation of the PSS-10 was created according to the principles of good translation (the existing English version was translated to Dutch by a native Dutch speaker, afterwards the translated Dutch version was compared to the original validated English version by a native English speaker)(</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.</measure>
      <time_frame>30 days postoperatively</time_frame>
      <description>The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.&#xD;
  The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)</measure>
      <time_frame>From admission to discharge</time_frame>
      <description>Every medication and dose provided to the patient is recorded in the EHR and will be extracted to assess possible differences in medication requirements between intervention and control group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>A self-made questionnaire assessing patient satisfaction regarding music intervention</measure>
      <time_frame>4 weeks postoperatively at follow-up</time_frame>
      <description>A 5-item questionnaire comprised of dichotomous and open ended questions regarding the patients satisfaction with the music intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of complications</measure>
      <time_frame>Postoperatively until 30 days follow-up</time_frame>
      <description>Complication documentation as provided my medical staff and associated Clavien-Dindo score</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.</measure>
      <time_frame>4 weeks postoperatively at follow-up</time_frame>
      <description>The quality of recovery will be assessed using de QoR-40 questionnaire, assessed at 30 days postoperatively. This is a questionnaire which assesses five subscales, including emotional state, physical independence, psychological support, pain and physical comfort. The questionnaire uses a five-point Likert scale.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Age</measure>
      <time_frame>At moment of surgery</time_frame>
      <description>In years</description>
    </other_outcome>
    <other_outcome>
      <measure>Sex</measure>
      <time_frame>at baseline</time_frame>
      <description>Male/Female</description>
    </other_outcome>
    <other_outcome>
      <measure>BMI</measure>
      <time_frame>At admittance</time_frame>
      <description>Quetelet index</description>
    </other_outcome>
    <other_outcome>
      <measure>Surgery characteristics</measure>
      <time_frame>Intraoperatively</time_frame>
      <description>Duration, type of procedure.</description>
    </other_outcome>
    <other_outcome>
      <measure>Prior medical history</measure>
      <time_frame>At baseline</time_frame>
      <description>Previous diagnoses, treatment</description>
    </other_outcome>
    <other_outcome>
      <measure>Music preferences in daily life. An 8-item researcher made questionnaire.</measure>
      <time_frame>At baseline</time_frame>
      <description>Items explore music listening activities, preferences for musical genres and potential music playing background. Question types varies from dichotomous answers to radio buttons, and dropdown lists.</description>
    </other_outcome>
    <other_outcome>
      <measure>Length of sedation in minutes</measure>
      <time_frame>Perioperatively</time_frame>
      <description>Length of peroperative sedation as recorded in EHR by attending anesthesist</description>
    </other_outcome>
    <other_outcome>
      <measure>Rate and type of complications during surgery as recorded in the EHR</measure>
      <time_frame>From entering the operation room to exit to postoperative nursing ward of post-anesthesia care unit (PACU)</time_frame>
      <description>Complications that occur during the surgery are recorded in the EHR and will be extracted</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">180</enrollment>
    <condition>Cancer of Colon</condition>
    <condition>Surgery</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>Music</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Music intervention at home. Patients will be asked to listen to music using their own equipment three times a day. Starting approximately a week prior to surgery up to the day of surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Treatment as usual.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Music</intervention_name>
      <description>Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.</description>
      <arm_group_label>Music</arm_group_label>
      <other_name>Music medicine</other_name>
      <other_name>music intervention</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged ≥ 16 years&#xD;
  &#xD;
            -  Patients undergoing elective oncological colorectal surgery at participating center&#xD;
  &#xD;
            -  Minimal hospital stay of 2 days postoperatively.&#xD;
  &#xD;
            -  Sufficient knowledge of the Dutch language&#xD;
  &#xD;
            -  Communicable and able to assess the questionnaires&#xD;
  &#xD;
            -  Patients who have access to personal music playing device and headphones/earphones. -&#xD;
               Written informed consent acquired from the patient&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with severe hearing impairment (defined as no or barely verbal communication&#xD;
               possible).&#xD;
  &#xD;
            -  Patients with an expected stay of less than two nights in the hospital&#xD;
  &#xD;
            -  Patients who are professional musicians.&#xD;
  &#xD;
            -  Active music players or singers who may play or sing every week&#xD;
  &#xD;
            -  Patients who actively listen to music with a duration of &gt; 30 minutes daily. Active&#xD;
               listening is defined as music listening with headphones/earphones, while this is not&#xD;
               combined with any other activity (e.g. exercising, working, driving or religious&#xD;
               activities).&#xD;
  &#xD;
            -  Patients who have a preoperative waiting period of less than five days.&#xD;
  &#xD;
            -  Participation in another study that may possibly intervene with the outcome measures.&#xD;
               (e.g. use of psychiatric medication during inclusion or prehabilitation interventions&#xD;
               or similar procedures according to the judgement of the research team)&#xD;
  &#xD;
            -  Assessment of primary outcome is not possible.&#xD;
  &#xD;
            -  Patients with mental disorders influencing their ability to adhere to the study&#xD;
               protocol and/or assess the questionnaires.&#xD;
  &#xD;
            -  Inability or unwillingness to receive the music intervention.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Markus Klimek, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Erasmus Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jorrit G Verhoeven, MSc, MD</last_name>
      <phone>+31107040163</phone>
      <email>j.g.verhoeven@erasmusmc.nl</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
      <investigator_full_name>Markus Klimek</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Music</keyword>
    <keyword>Colon cancer</keyword>
    <keyword>Surgery</keyword>
    <keyword>Anxiety</keyword>
    <keyword>Perioperative care</keyword>
    <keyword>Prehabilitation</keyword>
    <keyword>Non pharmacological intervention</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Colonic Neoplasms</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05982184
  org study id: 9411
  nct id: NCT05982184
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this multicenter randomized controlled trial is to investigate the effect of
        music prehabilitation on preoperative anxiety in patients undergoing elective oncological
        colorectal resection. Patients will be asked to listen to music three times a day starting
        one week before day of surgery. Anxiety levels will be compared with the control group that
        is not explicitly instructed to listen to music by using validated questionnaires
  Perioperative music interventions have been proven to have a positive effect on surgical
        patients regarding postoperative pain, anxiety and stress. Preoperative anxiety is a
        predictor for postoperative pain. It is hypothesized that preoperative anxiety develops at
        home. Unfortunately, data on this subject is scarce. Prehabilitation is a relatively new
        concept, which improves the patient's condition at home waiting for a surgical intervention.
        No studies exist in which music is implemented as a prehabilitation method. Music
        interventions are relatively simple low cost, sustainable and know no side effects. The
        researchers hypothesize that the use of pre-admittance music interventions as a
        prehabilitation modality in oncological colorectal surgical patients will decrease
        preoperative anxiety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Patient reported anxiety measured by the 6-item Spielberger State-trait Anxiety (STAI-6) inventory at admission.
  time frame: Baseline and day of admittance to hospital
  description: The STAI-6 questionnaire is a validated and frequently used six item questionnaire to assess anxiety. Six questions regarding feelings of anxiety are scored on a four point Likert scale. Scoring is achieved by reverse scoring of the positive items, sum all six scores, and multiplying the score by 20 divided by 6. The score ranges between 20 and 80, in which a higher score correlates with a higher anxiety level.
  measure: Patient reported pain on a 1-10 numeric scale.
  time frame: Thrice daily on each post-operative day until discharge
  description: Pain scores are gathered thrice daily by nurses as part of standard care
  measure: Incidence of delirium diagnosis made by geriatricians or psychiatrists
  time frame: Post-operative until discharge
  description: Diagnosis of delirium by geriatricians or psychiatrists as noted in the electronic health report were considered as a confirmed diagnosis of delirium
  measure: Delirium observation scale scores (DOS).
  time frame: Post-operative until discharge
  description: The DOS is a 13-point screen for delirium, based on Diagnostic and statistical manual of mental disorders version 4 (DSM-IV) delirium criteria, designed to be completed by a nurse. Responses are dichotomous. Scores ≥ 3 were considered positive delirium screens.
  measure: Subjective stress, measured with the 10-item perceived stress scale (PSS-10) questionnaire at baseline, day of admittance and at discharge.
  time frame: Baseline, day of admittance and discharge
  description: The PSS-10 is a validated questionnaire which assess subjective stress. It is a 10-item, comprehensive, reliable and valid instrument which is created and validated in the American population and widely used in medical/psychological studies. The items are each scored on a five-point Likert scale (ranging from 0 = never to 4 = very often). A Dutch translation of the PSS-10 was created according to the principles of good translation (the existing English version was translated to Dutch by a native Dutch speaker, afterwards the translated Dutch version was compared to the original validated English version by a native English speaker)(
  measure: Quality of life at 30 days postoperatively, measured with the EuroQol-5dimension-5length EQ-5D-5L questionnaire.
  time frame: 30 days postoperatively
  description: The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The descriptive system comprises five dimensions. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
  The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
  measure: Rate, timing and total dosages of medication given to the patient (sedatives, analgetics etc.)
  time frame: From admission to discharge
  description: Every medication and dose provided to the patient is recorded in the EHR and will be extracted to assess possible differences in medication requirements between intervention and control group
  measure: A self-made questionnaire assessing patient satisfaction regarding music intervention
  time frame: 4 weeks postoperatively at follow-up
  description: A 5-item questionnaire comprised of dichotomous and open ended questions regarding the patients satisfaction with the music intervention.
  measure: Rate of complications
  time frame: Postoperatively until 30 days follow-up
  description: Complication documentation as provided my medical staff and associated Clavien-Dindo score
  measure: Quality of recovery is a comprehensive 40-item questionnaire (QoR-40) used to assess the rate of recovery after surgery.
  time frame: 4 weeks postoperatively at follow-up
  description: The quality of recovery will be assessed using de QoR-40 questionnaire, assessed at 30 days postoperatively. This is a questionnaire which assesses five subscales, including emotional state, physical independence, psychological support, pain and physical comfort. The questionnaire uses a five-point Likert scale.
  measure: Age
  time frame: At moment of surgery
  description: In years
  measure: Sex
  time frame: at baseline
  description: Male/Female
  measure: BMI
  time frame: At admittance
  description: Quetelet index
  measure: Surgery characteristics
  time frame: Intraoperatively
  description: Duration, type of procedure.
  measure: Prior medical history
  time frame: At baseline
  description: Previous diagnoses, treatment
  measure: Music preferences in daily life. An 8-item researcher made questionnaire.
  time frame: At baseline
  description: Items explore music listening activities, preferences for musical genres and potential music playing background. Question types varies from dichotomous answers to radio buttons, and dropdown lists.
  measure: Length of sedation in minutes
  time frame: Perioperatively
  description: Length of peroperative sedation as recorded in EHR by attending anesthesist
  measure: Rate and type of complications during surgery as recorded in the EHR
  time frame: From entering the operation room to exit to postoperative nursing ward of post-anesthesia care unit (PACU)
  description: Complications that occur during the surgery are recorded in the EHR and will be extracted
  arm group label: Music
  arm group type: Experimental
  description: Music intervention at home. Patients will be asked to listen to music using their own equipment three times a day. Starting approximately a week prior to surgery up to the day of surgery.
  arm group label: Standard Care
  arm group type: No Intervention
  description: Treatment as usual.
  intervention type: Other
  intervention name: Music
  description: Patient preferred music listened to through earpieces or headphones using patients' own hardware and software.
  arm group label: Music
  other name: Music medicine
  other name: music intervention
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Markus Klimek, MD, PhD
  role: Principal Investigator
  affiliation: Erasmus Medical Center
  last name: Jorrit G Verhoeven, MSc, MD
  phone: +31107040163
  email: j.g.verhoeven@erasmusmc.nl
  responsible party type: Principal Investigator
  investigator affiliation: Erasmus Medical Center
  investigator full name: Markus Klimek
  investigator title: Principal Investigator
  mesh term: Colonic Neoplasms
  mesh term: Anxiety Disorders
  sharing ipd: No