Music Therapy on Nausea and Pain for Autologous Stem Cell

Study Overview
=================
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.

Official Title
-----------------
Assessment of the Use of Music Therapy on Nausea and Pain During Hospitalization for Autologous Stem Cell Transplantation

Conditions
-----------------
Multiple Myeloma, Non-Hodgkin Lymphoma, Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Other: Music Therapy
* Other: No music therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy<br>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<br>* 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<br>|
| Active Comparator: No music therapy<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient perception of nausea | Compare the difference in patient perception of nausea in those who receive music therapy and those who do not. | 7 days after intervention | 
| Patient perception of pain | Compare the difference in patient perception of pain in those who receive music therapy and those who do not. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Compare mood disturbance and quality of life in those who receive music therapy and those who do not. | 7 days | 
| 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). | 7 days | 
| 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. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous Stem Cell Transplantation, multiple myeloma, non-Hodgkin, Hodgkin lymphoma, Music Therapy, Nausea, Pain