<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/NCT02227680</url>
  </required_header>
  <id_info>
    <org_study_id>H-32796</org_study_id>
    <nct_id>NCT02227680</nct_id>
  </id_info>
  <brief_title>Massage Therapy Versus Music Therapy Pilot Study</brief_title>
  <official_title>Massage Therapy vs. Music Therapy vs. Usual Care in an Inpatient Setting: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Muscular Therapy Institute Foundation, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Berklee College of Music</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project studies the feasibility of (1) implementing massage therapy and music therapy&#xD;
      onto a busy medical inpatient unit at Boston Medical Center, and (2) evaluating massage&#xD;
      therapy and music therapy's impact on patient satisfaction, patient outcomes, and cost. The&#xD;
      investigators will conduct a randomized controlled trial comparing massage therapy, music&#xD;
      therapy, and usual care to collect preliminary data on critical outcomes for patients&#xD;
      (satisfaction, symptom control) and for the hospital (pain medication use and length of stay,&#xD;
      both critical drivers of cost). The investigators anticipate using these preliminary data to&#xD;
      apply for a future larger and longer adequately powered randomized controlled trial to&#xD;
      definitively answer the following research questions: does implementation of an inpatient&#xD;
      massage therapy and/or music therapy service (a) improve patient satisfaction; (b) reduce&#xD;
      symptoms such as pain; and (c) lower health care costs through less pain medication and&#xD;
      reduced length of stay?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized controlled trial compares massage therapy to usual care and music therapy to&#xD;
      usual care for patients admitted to the Family Medicine Inpatient Unit of Boston Medical&#xD;
      Center. Ninety family medicine inpatients will be recruited by the research assistant to&#xD;
      participate in the study. Participants will be randomized directly following consent in a&#xD;
      1:1:1 ratio to massage therapy, music therapy, or usual care. Individuals assigned to the&#xD;
      usual care group will receive the choice of a massage voucher for one massage at Boston&#xD;
      Medical Center's Integrative Medicine program or a music therapy CD following completion of&#xD;
      the study.&#xD;
&#xD;
      Treatment assignments will be prepared by the study biostatistician, using a permuted block&#xD;
      method with varying block sizes of 3, 6, and 9, prior to the start of the study. These will&#xD;
      be sealed in sequentially numbered opaque envelopes. This order will not be changed. A&#xD;
      research assistant will take a randomization envelope, in sequential order, and read the&#xD;
      treatment assignment to the participant following enrollment.&#xD;
&#xD;
      After enrollment and randomization is complete each day, the massage therapist and music&#xD;
      therapist will begin to see participants for treatment. Treatments will take place in the&#xD;
      inpatient hospital room. Curtains will be pulled closed to maintain privacy in rooms that&#xD;
      have two beds. Both music and massage therapists will be present Monday-Sunday to provide&#xD;
      treatment to participants.&#xD;
&#xD;
      Treatments will be attempted 1-3 times per day for the duration of the participant's stay on&#xD;
      the unit, based on the participant's availability (they may be scheduled for diagnostic&#xD;
      tests, imaging, consults, etc). The music and massage therapists will work down the list of&#xD;
      participants, visiting each one by one and administering treatment (details below for each&#xD;
      therapy). If a participant is not available at the time the therapist comes by, he/she will&#xD;
      revisit the participant after they have gone through their list and administered treatments.&#xD;
      Once the therapist has provided the therapy once to every patient on his/her list, he/she&#xD;
      will begin at the top of the list and provide a second round of treatments, and repeat again&#xD;
      for a third round as time permits.&#xD;
&#xD;
      The music therapist and massage therapist will create a note sheet each day for each&#xD;
      participant. This will allow them to track number of treatments as well as any comments&#xD;
      relevant to treatment (patient preferences, etc). A research assistant will collect these at&#xD;
      the end of each day, enter them into the secure online database, and store them in a locked&#xD;
      file cabinet.&#xD;
&#xD;
      The music therapist and massage therapist will each be given an updated list of patients to&#xD;
      treat (first name, last initial, room number) each morning. These lists (separated by&#xD;
      treatment group) will include the newly enrolled and randomized participants as well as those&#xD;
      who have not yet been discharged. At the end of each day, the therapists will report to the&#xD;
      research assistant on how many sessions were provided to each participant.&#xD;
&#xD;
      When the research assistant notes that a participant has been discharged, he/she has&#xD;
      approximately 7 days to contact the patient (by phone or email) to administer the endline&#xD;
      survey. Then, thirty days after discharge, the research assistant will check the&#xD;
      participant's electronic medical record to see if he/she has been admitted again since&#xD;
      discharge. Participants in the control group, following discharge and completion of the&#xD;
      endline survey, will be mailed either a music/meditation CD or a voucher for massage at BMC,&#xD;
      according to their preference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>within 7 days after discharge</time_frame>
    <description>Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey questions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain medication use</measure>
    <time_frame>duration of hospital stay, an expected average of 4 days</time_frame>
    <description>Administration of pain medication is documented in the electronic medical record each time a dose is given. We will use the EMR to document number of doses and amount (mg) of each dose during the participant's stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedative use</measure>
    <time_frame>duration of hospital stay, an expected average of 4 days</time_frame>
    <description>Administration of sedatives is documented in the electronic medical record each time a dose is given. We will use the EMR to document number of doses and amount (mg) of each dose during the participant's stay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>duration of hospital stay, an expected average of 4 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of re-admissions 30 days after initial discharge</measure>
    <time_frame>30 days post-discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain level</measure>
    <time_frame>duration of hospital stay, an expected average of 4 days</time_frame>
    <description>Pain levels are documented for every patient by nurses on a daily basis. We will utilize the electronic medical record (EMR) and document every pain evaluation (0-10 point scale of current pain intensity) performed by nurses on inpatient unit during participant's stay.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>ALL</condition>
  <arm_group>
    <arm_group_label>Music Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the music therapy group will receive 1-3 10-40 minute music therapy sessions during each of the days of their stay on the inpatient unit. Each participant randomized to the music therapy intervention will be given a personalized CD and one portable CD player with headphones which they may keep after the study has ended.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Massage Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to the massage therapy group will receive 1-3 10-40 minute massage treatments during each of the days of their stay on the inpatient unit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will continue to receive usual care while on the Family Medicine Inpatient Unit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Music Therapy</intervention_name>
    <description>Each music therapy session will begin with a brief description of the protocol, a musical introduction, a discussion of music preferences, and an informal assessment of participant needs to determine target goals, e.g., management of pain, anxiety, and other symptoms; breath control; emotional support and regulation. After the initial visit, the music therapist will create a playlist, based on participant preferences, and burn it onto a CD for the participant. The participant will be encouraged to use the book and listen to the CDs as often as he/she would like. After the initial visit, follow up visits will include techniques like music-facilitated breathing, music and imagery, music and relaxation/meditation, song writing, improvisation, singing, lyric substitution, lyric analysis, musical reminiscence, passive listening. There will be the opportunity to create music and write songs across multiple sessions, if these activities are indicated.</description>
    <arm_group_label>Music Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massage Therapy</intervention_name>
    <description>Working with experts in hospital-based massage therapy, we have developed a semi-standardized inpatient massage protocol that utilizes Swedish techniques and acupressure. The protocol was adapted from our successful previous study of massage for perioperative care of patients undergoing implantation of permanent intravenous access devices. Massage therapists will focus on hands, feet, arms, and neck, as able, during the treatments.</description>
    <arm_group_label>Massage Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  Inpatient on the Boston Medical C enter Family Medicine inpatient service&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Contagious skin disease or infection&#xD;
&#xD;
          -  Hemophilia&#xD;
&#xD;
          -  Thrombocytopenia&#xD;
&#xD;
          -  Encephalopathy&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Altered mental status&#xD;
&#xD;
          -  1:1 status (requiring constant supervision)&#xD;
&#xD;
          -  Any condition, as determined by the attending physician, which would prevent&#xD;
             participation in the study.&#xD;
&#xD;
          -  Observation status&#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>Robert B Saper, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>music therapy</keyword>
  <keyword>massage therapy</keyword>
  <!-- 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/NCT02227680
org study id: H-32796
nct id: NCT02227680
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This project studies the feasibility of (1) implementing massage therapy and music therapy
      onto a busy medical inpatient unit at Boston Medical Center, and (2) evaluating massage
      therapy and music therapy's impact on patient satisfaction, patient outcomes, and cost. The
      investigators will conduct a randomized controlled trial comparing massage therapy, music
      therapy, and usual care to collect preliminary data on critical outcomes for patients
      (satisfaction, symptom control) and for the hospital (pain medication use and length of stay,
      both critical drivers of cost). The investigators anticipate using these preliminary data to
      apply for a future larger and longer adequately powered randomized controlled trial to
      definitively answer the following research questions: does implementation of an inpatient
      massage therapy and/or music therapy service (a) improve patient satisfaction; (b) reduce
      symptoms such as pain; and (c) lower health care costs through less pain medication and
      reduced length of stay?
This randomized controlled trial compares massage therapy to usual care and music therapy to
      usual care for patients admitted to the Family Medicine Inpatient Unit of Boston Medical
      Center. Ninety family medicine inpatients will be recruited by the research assistant to
      participate in the study. Participants will be randomized directly following consent in a
      1:1:1 ratio to massage therapy, music therapy, or usual care. Individuals assigned to the
      usual care group will receive the choice of a massage voucher for one massage at Boston
      Medical Center's Integrative Medicine program or a music therapy CD following completion of
      the study.

      Treatment assignments will be prepared by the study biostatistician, using a permuted block
      method with varying block sizes of 3, 6, and 9, prior to the start of the study. These will
      be sealed in sequentially numbered opaque envelopes. This order will not be changed. A
      research assistant will take a randomization envelope, in sequential order, and read the
      treatment assignment to the participant following enrollment.

      After enrollment and randomization is complete each day, the massage therapist and music
      therapist will begin to see participants for treatment. Treatments will take place in the
      inpatient hospital room. Curtains will be pulled closed to maintain privacy in rooms that
      have two beds. Both music and massage therapists will be present Monday-Sunday to provide
      treatment to participants.

      Treatments will be attempted 1-3 times per day for the duration of the participant's stay on
      the unit, based on the participant's availability (they may be scheduled for diagnostic
      tests, imaging, consults, etc). The music and massage therapists will work down the list of
      participants, visiting each one by one and administering treatment (details below for each
      therapy). If a participant is not available at the time the therapist comes by, he/she will
      revisit the participant after they have gone through their list and administered treatments.
      Once the therapist has provided the therapy once to every patient on his/her list, he/she
      will begin at the top of the list and provide a second round of treatments, and repeat again
      for a third round as time permits.

      The music therapist and massage therapist will create a note sheet each day for each
      participant. This will allow them to track number of treatments as well as any comments
      relevant to treatment (patient preferences, etc). A research assistant will collect these at
      the end of each day, enter them into the secure online database, and store them in a locked
      file cabinet.

      The music therapist and massage therapist will each be given an updated list of patients to
      treat (first name, last initial, room number) each morning. These lists (separated by
      treatment group) will include the newly enrolled and randomized participants as well as those
      who have not yet been discharged. At the end of each day, the therapists will report to the
      research assistant on how many sessions were provided to each participant.

      When the research assistant notes that a participant has been discharged, he/she has
      approximately 7 days to contact the patient (by phone or email) to administer the endline
      survey. Then, thirty days after discharge, the research assistant will check the
      participant's electronic medical record to see if he/she has been admitted again since
      discharge. Participants in the control group, following discharge and completion of the
      endline survey, will be mailed either a music/meditation CD or a voucher for massage at BMC,
      according to their preference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Patient satisfaction
time frame: within 7 days after discharge
description: Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey questions
measure: Pain medication use
time frame: duration of hospital stay, an expected average of 4 days
description: Administration of pain medication is documented in the electronic medical record each time a dose is given. We will use the EMR to document number of doses and amount (mg) of each dose during the participant's stay.
measure: Sedative use
time frame: duration of hospital stay, an expected average of 4 days
description: Administration of sedatives is documented in the electronic medical record each time a dose is given. We will use the EMR to document number of doses and amount (mg) of each dose during the participant's stay.
measure: Length of stay
time frame: duration of hospital stay, an expected average of 4 days
measure: Number of re-admissions 30 days after initial discharge
time frame: 30 days post-discharge
measure: Pain level
time frame: duration of hospital stay, an expected average of 4 days
description: Pain levels are documented for every patient by nurses on a daily basis. We will utilize the electronic medical record (EMR) and document every pain evaluation (0-10 point scale of current pain intensity) performed by nurses on inpatient unit during participant's stay.
arm group label: Music Therapy
arm group type: Active Comparator
description: Patients randomized to the music therapy group will receive 1-3 10-40 minute music therapy sessions during each of the days of their stay on the inpatient unit. Each participant randomized to the music therapy intervention will be given a personalized CD and one portable CD player with headphones which they may keep after the study has ended.
arm group label: Massage Therapy
arm group type: Active Comparator
description: Patients randomized to the massage therapy group will receive 1-3 10-40 minute massage treatments during each of the days of their stay on the inpatient unit.
arm group label: Usual Care
arm group type: No Intervention
description: The control group will continue to receive usual care while on the Family Medicine Inpatient Unit.
intervention type: Other
intervention name: Music Therapy
description: Each music therapy session will begin with a brief description of the protocol, a musical introduction, a discussion of music preferences, and an informal assessment of participant needs to determine target goals, e.g., management of pain, anxiety, and other symptoms; breath control; emotional support and regulation. After the initial visit, the music therapist will create a playlist, based on participant preferences, and burn it onto a CD for the participant. The participant will be encouraged to use the book and listen to the CDs as often as he/she would like. After the initial visit, follow up visits will include techniques like music-facilitated breathing, music and imagery, music and relaxation/meditation, song writing, improvisation, singing, lyric substitution, lyric analysis, musical reminiscence, passive listening. There will be the opportunity to create music and write songs across multiple sessions, if these activities are indicated.
arm group label: Music Therapy
intervention type: Other
intervention name: Massage Therapy
description: Working with experts in hospital-based massage therapy, we have developed a semi-standardized inpatient massage protocol that utilizes Swedish techniques and acupressure. The protocol was adapted from our successful previous study of massage for perioperative care of patients undergoing implantation of permanent intravenous access devices. Massage therapists will focus on hands, feet, arms, and neck, as able, during the treatments.
arm group label: Massage Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert B Saper, MD, MPH
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Sponsor