Music Therapy on Nausea and Pain for Autologous Stem Cell

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01487031
First received: December 5, 2011
Last updated: July 31, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Multiple Myeloma
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Other: Music Therapy
Other: No music therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Assessment of the Use of Music Therapy on Nausea and Pain During Hospitalization for Autologous Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Patient perception of nausea [ Time Frame: 7 days after intervention ] [ Designated as safety issue: No ]
    Compare the difference in patient perception of nausea in those who receive music therapy and those who do not.

  • Patient perception of pain [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Compare mood disturbance and quality of life in those who receive music therapy and those who do not.

  • Use of "as needed" narcotic medications [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 108
Study Start Date: November 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Music Therapy
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.
Other: Music Therapy
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
Active Comparator: No music therapy
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.
Other: No music therapy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487031

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Hien Duong, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01487031     History of Changes
Other Study ID Numbers: CASE11Z10
Study First Received: December 5, 2011
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
Autologous Stem Cell Transplantation
multiple myeloma
non-Hodgkin
Hodgkin lymphoma
Music Therapy
Nausea
Pain

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on September 22, 2014