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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01487031
Enrollment
108
Registered
2011-12-07
Start date
2011-11-30
Completion date
2013-04-30
Last updated
2013-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma, Multiple Myeloma, Non-Hodgkin Lymphoma

Keywords

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

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.

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

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.

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

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

Design outcomes

Primary

MeasureTime frameDescription
Patient perception of nausea7 days after interventionCompare the difference in patient perception of nausea in those who receive music therapy and those who do not.
Patient perception of pain7 daysCompare the difference in patient perception of pain in those who receive music therapy and those who do not.

Secondary

MeasureTime frameDescription
Quality of life7 daysCompare mood disturbance and quality of life in those who receive music therapy and those who do not.
Use of as needed narcotic medications7 daysCompare 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 responsiveness7 daysCompare 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026