<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/NCT03829813</url>
  </required_header>
  <id_info>
    <org_study_id>REB18-1145</org_study_id>
    <nct_id>NCT03829813</nct_id>
  </id_info>
  <brief_title>Effects of Music Therapy on Mood, Pain, Patient and Staff Satisfaction on Adult Inpatient Neurological Units</brief_title>
  <official_title>Does Music Therapy Improve Patient Mood, Pain, Satisfaction and Caregiver Satisfaction on Adult Inpatient Acute Neurological Units?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Music Centre Studio Bell</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Calgary</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>
      A study examining the benefits of music therapy on patients, families, and unit staff on&#xD;
      acute neurologic or inpatient rehabilitation units.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: Does music therapy improve mood, pain and patient satisfaction on adult inpatient&#xD;
      neurological units? Is music therapy an acceptable and feasible intervention in an adult&#xD;
      inpatient neurological unit based on patient, family, and care provider satisfaction&#xD;
      measures?&#xD;
&#xD;
      Population: Foothills Medical Centre (FMC) acute neurological and neurorehabilitation units&#xD;
      (i.e., 111, 112, 101, 58 Neurorehab), ages &gt;18&#xD;
&#xD;
      Background: Music therapy is the therapeutic application of music to rehabilitate cognitive,&#xD;
      motor, and sensory dysfunction due to disease. Its treatment techniques are based upon&#xD;
      scientific knowledge of music perception, production and its effects on nonmusical brain and&#xD;
      behavior functions like gait, balance, speech, mood and motivation. Music is also known to&#xD;
      have a wide range of physiological effects on the human body including changes in heart rate,&#xD;
      respiration, blood pressure, skin temperature, and muscle tension. Music provokes emotions&#xD;
      mediated via neuro-hormones such as serotonin and dopamine, and is experienced as joyous or&#xD;
      rewarding through activity changes in the amygdala, ventral striatum and other parts of the&#xD;
      limbic system.&#xD;
&#xD;
      Music therapy has been applied across a broad range of clinical conditions from inpatients to&#xD;
      outpatients, cardiac, diabetes and cancer care to surgical and ICU settings, and in pediatric&#xD;
      through adult and geriatric populations. The majority of clinical studies focus on&#xD;
      neurological patients with sensorimotor, speech and gait impairments, however, music has been&#xD;
      shown to improve mental state and functioning in a wide variety of psychiatric disorders&#xD;
      including depression, anxiety, and dementia, as well as reducing anxiety in patients with&#xD;
      asthma, osteoarthritis, those undergoing dental procedures or perioperative anesthesia. There&#xD;
      is some research to support its mood benefits in stroke and brain injury patients.&#xD;
&#xD;
      Music therapy has been found to be an effective complementary treatment for cancer-related&#xD;
      pain, lithotripsy, labor, and fibromyalgia. Recent reviews have demonstrated reductions in&#xD;
      postoperative pain and anxiety, decreased consumption of sedatives and analgesics and&#xD;
      increased patient satisfaction. The reductions in anxiety were equal or greater than&#xD;
      midazolam/benzodiazepines. This may be particularly beneficial in neurological patients who&#xD;
      may be more susceptible to adverse effects from psychoactive, sedating and analgesic&#xD;
      medications. Music can provide a filter for unpleasant, unfamiliar sounds common to the&#xD;
      hospital environment and improve sleep quality. These positive effects may greatly assist the&#xD;
      common issues of fatigue in cognitively impaired, confused or agitated neurological&#xD;
      inpatients. Furthermore, Chlan has recently demonstrated cost-effectiveness of music therapy&#xD;
      interventions in reducing anxiety in the ICU.&#xD;
&#xD;
      Music therapy may also have beneficial effects for staff and families. Some studies have&#xD;
      demonstrated cost-effectiveness with less staff time required for procedures, administering&#xD;
      sedatives and pain medications, and fewer days on mechanical ventilation in the ICU.&#xD;
      Perez-Cruz studied patients, relatives, and healthcare workers' preference for background&#xD;
      music in patient areas with an average 71% in all three groups. Lower perceived stress level,&#xD;
      cortisol, heart rate and mean arterial pressures were also observed in voluntary first-line&#xD;
      nurses and students while listening to music.&#xD;
&#xD;
      This study will expand the research base in the inpatient neurological population and explore&#xD;
      staff perceptions and satisfaction with music therapy. The aim of this mixed methods study is&#xD;
      to explore immediate pre and post music therapy intervention effects on mood, pain, and&#xD;
      satisfaction in the inpatient neurological population and to explore perceived caregiver and&#xD;
      staff satisfaction with music therapy on inpatient neurological units.&#xD;
&#xD;
      Intervention: 20-40 min treatment sessions 1:1 within acute neurological patient rooms, or&#xD;
      private room by qualified music therapist once weekly and/or group music therapy sessions&#xD;
      maximum 6-8 patients &lt; or = 1 hour. This includes a variety of music therapy techniques used&#xD;
      to target mood, pain, socialization, expressive speech, attention/cognitive or sensorimotor&#xD;
      functional goals.&#xD;
&#xD;
      Methods: Mixed methods study design.&#xD;
&#xD;
        1. Qualitative measures:&#xD;
&#xD;
             1. Semi-structured patient +/- family satisfaction questionnaire and interview post&#xD;
                music therapy session&#xD;
&#xD;
             2. Semi-structured inpatient unit staff questionnaire and interview (exploring themes&#xD;
                of: self-perceived stress, workload, barriers, relationships, mood, pain)&#xD;
&#xD;
             3. Focus groups of patients, families, staff addressing above areas&#xD;
&#xD;
        2. Quantitative measures:&#xD;
&#xD;
             1. Visual analog scale, mood pre- and post- music therapy session&#xD;
&#xD;
             2. Visual analog scale, pain pre- and post- music therapy session&#xD;
&#xD;
      Recruitment: Patients (and their families when available) referred to Music therapy on Acute&#xD;
      Neuro, Neurorehab units would be invited to participate in research study with informed&#xD;
      consent obtained prior to interviews, focus groups and data collection. Unit Staff would also&#xD;
      be invited to participate in interviews and focus groups with informed consent prior to data&#xD;
      collection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">March 16, 2020</completion_date>
  <primary_completion_date type="Actual">March 16, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Mixed methods study with pre and post intervention surveys and Visual analog scales, combined with focus groups/interviews of patients, family members and staff</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Qualitative data from focus groups</measure>
    <time_frame>Up to 1 month following music therapy intervention</time_frame>
    <description>Questions within the interview are designed to more deeply explore the areas of music therapy and how this program may influence stress, mood, pain, and the relationships between participants, caregivers, and hospital staff. Interviews will also touch upon barriers to music therapy involvement as experienced.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Visual Analogue Scale</measure>
    <time_frame>T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment</time_frame>
    <description>Measurement instrument that measures participants subjective perception of pain believed to range across a continuum of values.&#xD;
Scale: 0 (minimum, no pain) - 10 (maximum, very severe pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood Visual Analogue Scale</measure>
    <time_frame>T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment</time_frame>
    <description>0 (minimum, not at all happy) - 10 (maximum, very happy).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment</time_frame>
    <description>Likert Scale:&#xD;
- Very dissatisfied&#xD;
- Somewhat dissatisfied&#xD;
- Neutral&#xD;
- Somewhat satisfied&#xD;
- Very satisfied</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Music Therapy</condition>
  <condition>Pain</condition>
  <condition>Patient Satisfaction</condition>
  <condition>Inpatients</condition>
  <condition>Affect</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Music therapy sessions. Planned 1:1 within acute neurology/rehabilitation patient rooms, or private rooms by a qualified music therapist once weekly and/or group music therapy sessions maximum 6-8 patients for less than or equal to one hour. Music therapy includes a variety of techniques used to target mood, pain, socialisation, expressive speech, attention/cognitive or sensorimotor functional goals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Family participation in music therapy treatment sessions. Planned 1:1 within acute neurology/rehabilitation patient rooms, or private rooms by a qualified music therapist once weekly and/or group music therapy sessions maximum 6-8 patients for less than or equal to one hour.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Administration and Staff</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Staff/Administration are not participants in music therapy, but rather have observed sessions, or worked as co-treating clinicians with music therapists for patient participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music therapy</intervention_name>
    <description>20 to 40 minute music therapy treatment session with a qualified music therapist.</description>
    <arm_group_label>Administration and Staff</arm_group_label>
    <arm_group_label>Family</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acute neurological inpatients and their families at Foothills Medical Centre that are&#xD;
             receiving music therapy&#xD;
&#xD;
          -  Unit staff involved in care of patients receiving music therapy as inpatients&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking participants&#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>Stephanie Plamondon</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothill Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 26, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>November 23, 2020</last_update_submitted>
  <last_update_submitted_qc>November 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03829813
org study id: REB18-1145
nct id: NCT03829813
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A study examining the benefits of music therapy on patients, families, and unit staff on
      acute neurologic or inpatient rehabilitation units.
Objective: Does music therapy improve mood, pain and patient satisfaction on adult inpatient
      neurological units? Is music therapy an acceptable and feasible intervention in an adult
      inpatient neurological unit based on patient, family, and care provider satisfaction
      measures?

      Population: Foothills Medical Centre (FMC) acute neurological and neurorehabilitation units
      (i.e., 111, 112, 101, 58 Neurorehab), ages >18

      Background: Music therapy is the therapeutic application of music to rehabilitate cognitive,
      motor, and sensory dysfunction due to disease. Its treatment techniques are based upon
      scientific knowledge of music perception, production and its effects on nonmusical brain and
      behavior functions like gait, balance, speech, mood and motivation. Music is also known to
      have a wide range of physiological effects on the human body including changes in heart rate,
      respiration, blood pressure, skin temperature, and muscle tension. Music provokes emotions
      mediated via neuro-hormones such as serotonin and dopamine, and is experienced as joyous or
      rewarding through activity changes in the amygdala, ventral striatum and other parts of the
      limbic system.

      Music therapy has been applied across a broad range of clinical conditions from inpatients to
      outpatients, cardiac, diabetes and cancer care to surgical and ICU settings, and in pediatric
      through adult and geriatric populations. The majority of clinical studies focus on
      neurological patients with sensorimotor, speech and gait impairments, however, music has been
      shown to improve mental state and functioning in a wide variety of psychiatric disorders
      including depression, anxiety, and dementia, as well as reducing anxiety in patients with
      asthma, osteoarthritis, those undergoing dental procedures or perioperative anesthesia. There
      is some research to support its mood benefits in stroke and brain injury patients.

      Music therapy has been found to be an effective complementary treatment for cancer-related
      pain, lithotripsy, labor, and fibromyalgia. Recent reviews have demonstrated reductions in
      postoperative pain and anxiety, decreased consumption of sedatives and analgesics and
      increased patient satisfaction. The reductions in anxiety were equal or greater than
      midazolam/benzodiazepines. This may be particularly beneficial in neurological patients who
      may be more susceptible to adverse effects from psychoactive, sedating and analgesic
      medications. Music can provide a filter for unpleasant, unfamiliar sounds common to the
      hospital environment and improve sleep quality. These positive effects may greatly assist the
      common issues of fatigue in cognitively impaired, confused or agitated neurological
      inpatients. Furthermore, Chlan has recently demonstrated cost-effectiveness of music therapy
      interventions in reducing anxiety in the ICU.

      Music therapy may also have beneficial effects for staff and families. Some studies have
      demonstrated cost-effectiveness with less staff time required for procedures, administering
      sedatives and pain medications, and fewer days on mechanical ventilation in the ICU.
      Perez-Cruz studied patients, relatives, and healthcare workers' preference for background
      music in patient areas with an average 71% in all three groups. Lower perceived stress level,
      cortisol, heart rate and mean arterial pressures were also observed in voluntary first-line
      nurses and students while listening to music.

      This study will expand the research base in the inpatient neurological population and explore
      staff perceptions and satisfaction with music therapy. The aim of this mixed methods study is
      to explore immediate pre and post music therapy intervention effects on mood, pain, and
      satisfaction in the inpatient neurological population and to explore perceived caregiver and
      staff satisfaction with music therapy on inpatient neurological units.

      Intervention: 20-40 min treatment sessions 1:1 within acute neurological patient rooms, or
      private room by qualified music therapist once weekly and/or group music therapy sessions
      maximum 6-8 patients < or = 1 hour. This includes a variety of music therapy techniques used
      to target mood, pain, socialization, expressive speech, attention/cognitive or sensorimotor
      functional goals.

      Methods: Mixed methods study design.

        1. Qualitative measures:

             1. Semi-structured patient +/- family satisfaction questionnaire and interview post
                music therapy session

             2. Semi-structured inpatient unit staff questionnaire and interview (exploring themes
                of: self-perceived stress, workload, barriers, relationships, mood, pain)

             3. Focus groups of patients, families, staff addressing above areas

        2. Quantitative measures:

             1. Visual analog scale, mood pre- and post- music therapy session

             2. Visual analog scale, pain pre- and post- music therapy session

      Recruitment: Patients (and their families when available) referred to Music therapy on Acute
      Neuro, Neurorehab units would be invited to participate in research study with informed
      consent obtained prior to interviews, focus groups and data collection. Unit Staff would also
      be invited to participate in interviews and focus groups with informed consent prior to data
      collection.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: Mixed methods study with pre and post intervention surveys and Visual analog scales, combined with focus groups/interviews of patients, family members and staff
primary purpose: Treatment
masking: None (Open Label)
measure: Qualitative data from focus groups
time frame: Up to 1 month following music therapy intervention
description: Questions within the interview are designed to more deeply explore the areas of music therapy and how this program may influence stress, mood, pain, and the relationships between participants, caregivers, and hospital staff. Interviews will also touch upon barriers to music therapy involvement as experienced.
measure: Pain Visual Analogue Scale
time frame: T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment
description: Measurement instrument that measures participants subjective perception of pain believed to range across a continuum of values.
Scale: 0 (minimum, no pain) - 10 (maximum, very severe pain).
measure: Mood Visual Analogue Scale
time frame: T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment
description: 0 (minimum, not at all happy) - 10 (maximum, very happy).
measure: Patient Satisfaction
time frame: T0 (prior to music therapy treatment, T(1) immediately following music therapy treatment
description: Likert Scale:
- Very dissatisfied
- Somewhat dissatisfied
- Neutral
- Somewhat satisfied
- Very satisfied
arm group label: Patients
arm group type: Experimental
description: Music therapy sessions. Planned 1:1 within acute neurology/rehabilitation patient rooms, or private rooms by a qualified music therapist once weekly and/or group music therapy sessions maximum 6-8 patients for less than or equal to one hour. Music therapy includes a variety of techniques used to target mood, pain, socialisation, expressive speech, attention/cognitive or sensorimotor functional goals.
arm group label: Family
arm group type: Experimental
description: Family participation in music therapy treatment sessions. Planned 1:1 within acute neurology/rehabilitation patient rooms, or private rooms by a qualified music therapist once weekly and/or group music therapy sessions maximum 6-8 patients for less than or equal to one hour.
arm group label: Administration and Staff
arm group type: Experimental
description: Staff/Administration are not participants in music therapy, but rather have observed sessions, or worked as co-treating clinicians with music therapists for patient participants.
intervention type: Other
intervention name: Music therapy
description: 20 to 40 minute music therapy treatment session with a qualified music therapist.
arm group label: Administration and Staff
arm group label: Family
arm group label: Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephanie Plamondon
role: Principal Investigator
affiliation: University of Calgary
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No