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CompletedNCT01487031Updated Aug 2, 2013

Music Therapy on Nausea and Pain for Autologous Stem Cell

An interventional study of Music Therapy and No music therapy in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Lymphoma, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-02.

Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Myeloma
  • Non-Hodgkin Lymphoma
  • Hodgkin Lymphoma

Keywords

  • Autologous Stem Cell Transplantation
  • multiple myeloma
  • non-Hodgkin
  • Hodgkin lymphoma
  • Music Therapy
  • Nausea
  • Pain
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 108 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Have had previous ASCT
  • Have a diagnosis of leukemia
  • History of prior music therapy
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
108 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherMusic 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

  • OtherNo 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.

06

What researchers measure

Primary outcomes

  1. Patient perception of nausea

    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

  2. Patient perception of pain

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

    Time frame: 7 days

Secondary outcomes

  1. Quality of life

    Compare mood disturbance and quality of life in those who receive music therapy and those who do not.

    Time frame: 7 days

  2. 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).

    Time frame: 7 days

  3. 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.

    Time frame: 7 days

07

Study locations

1 site
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01487031
Lead sponsor
Case Comprehensive Cancer Center
Responsible party
Sponsor
First posted
Dec 7, 2011
Start date
Nov 2011
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Aug 2, 2013

Study contacts

Hien Duong, MD
principal investigator · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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