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Music Therapy on Nausea and Pain for Autologous Stem Cell

Primary Purpose

Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Therapy
No music therapy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring Autologous Stem Cell Transplantation, multiple myeloma, non-Hodgkin, Hodgkin lymphoma, Music Therapy, Nausea, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Be older than 18 years of age
  • Have a diagnosis of multiple myeloma, non-Hodgkin, or Hodgkin lymphoma
  • Be undergoing ASCT (Autologous Stem Cell Transplantation)

Exclusion Criteria:

  • Have had previous ASCT
  • Have a diagnosis of leukemia
  • History of prior music therapy

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Therapy

No music therapy

Arm Description

Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room.

Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist.

Outcomes

Primary Outcome Measures

Patient perception of nausea
Compare the difference in patient perception of nausea in those who receive music therapy and those who do not.
Patient perception of pain
Compare the difference in patient perception of pain in those who receive music therapy and those who do not.

Secondary Outcome Measures

Quality of life
Compare mood disturbance and quality of life in those who receive music therapy and those who do not.
Use of "as needed" narcotic medications
Compare the difference in the use of "as needed" narcotic medications in those who receive music therapy and those who do not (using morphine equivalent doses).
Monitoring of physiologic responsiveness
Compare non-invasive monitoring of physiologic responsiveness to provide an index of autonomic nervous system function, or general arousal. We hypothesize that arousal will decrease after music therapy, and will be indicated by a decrease in skin conductance, an increase in finger temperature, and an increase in heart rate variability. Measurements in the control group will provide a background level of how much physiologic arousal changes with time, independent of music therapy.

Full Information

First Posted
December 5, 2011
Last Updated
July 31, 2013
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01487031
Brief Title
Music Therapy on Nausea and Pain for Autologous Stem Cell
Official Title
Assessment of the Use of Music Therapy on Nausea and Pain During Hospitalization for Autologous Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Autologous stem cell transplant (ASCT) is an important therapy for patients with multiple myeloma, non-Hodgkin's lymphoma, and Hodgkin's lymphoma. It has been shown to improve progression free survival and overall survival. However, it is a challenging treatment process both physically and psychologically. It is a procedure with many side effects that can be uncomfortable, painful, and at times, difficult to endure. Complementary therapies, such as music therapy, have potential to be an important adjunct in palliation of symptoms in patients undergoing chemotherapy.
Detailed Description
Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room. This will occur between days -1 and +5, with the first music therapy session being as close to day +1 as possible and the second session being at least 48 hours later (but no more than 96 hours later). Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist. Following day +7, music therapy will be offered to all patients who are interested in participating. No narcotic or anti-emetic therapy will be administered for at least 2 hours prior to music therapy sessions or to assessments. Patients will rate nausea and pain at the beginning and end of the first music therapy session on a validated visual analog scale.12-14 The scale will be 10cm with the least nausea or pain at point 0 and the greatest nausea or pain at point 10. Patients will be asked to rate their nausea and pain on day +5 and day +7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Keywords
Autologous Stem Cell Transplantation, multiple myeloma, non-Hodgkin, Hodgkin lymphoma, Music Therapy, Nausea, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room.
Arm Title
No music therapy
Arm Type
Active Comparator
Arm Description
Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist.
Intervention Type
Other
Intervention Name(s)
Music Therapy
Intervention Description
Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room
Intervention Type
Other
Intervention Name(s)
No music therapy
Intervention Description
Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist.
Primary Outcome Measure Information:
Title
Patient perception of nausea
Description
Compare the difference in patient perception of nausea in those who receive music therapy and those who do not.
Time Frame
7 days after intervention
Title
Patient perception of pain
Description
Compare the difference in patient perception of pain in those who receive music therapy and those who do not.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Quality of life
Description
Compare mood disturbance and quality of life in those who receive music therapy and those who do not.
Time Frame
7 days
Title
Use of "as needed" narcotic medications
Description
Compare the difference in the use of "as needed" narcotic medications in those who receive music therapy and those who do not (using morphine equivalent doses).
Time Frame
7 days
Title
Monitoring of physiologic responsiveness
Description
Compare non-invasive monitoring of physiologic responsiveness to provide an index of autonomic nervous system function, or general arousal. We hypothesize that arousal will decrease after music therapy, and will be indicated by a decrease in skin conductance, an increase in finger temperature, and an increase in heart rate variability. Measurements in the control group will provide a background level of how much physiologic arousal changes with time, independent of music therapy.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be older than 18 years of age Have a diagnosis of multiple myeloma, non-Hodgkin, or Hodgkin lymphoma Be undergoing ASCT (Autologous Stem Cell Transplantation) Exclusion Criteria: Have had previous ASCT Have a diagnosis of leukemia History of prior music therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hien Duong, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Music Therapy on Nausea and Pain for Autologous Stem Cell

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