Clinical trial NCT01487031: 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
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Non-Hodgkin Lymphoma
Hodgkin Lymphoma
Keywords: Autologous Stem Cell Transplantation
multiple myeloma
non-Hodgkin
Hodgkin lymphoma
Music Therapy
Nausea
Pain
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2011-12-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient perception of nausea
timeFrame: 7 days after intervention
measure: Patient perception of pain
timeFrame: 7 days
Secondary outcomes:
measure: Quality of life
timeFrame: 7 days
measure: Use of "as needed" narcotic medications
timeFrame: 7 days
measure: Monitoring of physiologic responsiveness
timeFrame: 7 days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Hien Duong, MD
role: PRINCIPAL_INVESTIGATOR
References: