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

December 5, 2011
July 31, 2013
November 2011
April 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01487031 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Music Therapy on Nausea and Pain for Autologous Stem Cell
Assessment of the Use of Music Therapy on Nausea and Pain During Hospitalization for Autologous Stem Cell Transplantation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • Hodgkin Lymphoma
  • 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
  • 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.
  • 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.
    Intervention: Other: Music Therapy
  • 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.
    Intervention: Other: No music therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01487031
CASE11Z10
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
Not Provided
Principal Investigator: Hien Duong, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP