Music Therapy on Nausea and Pain for Autologous Stem Cell

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01487031
• Other study ID #: CASE11Z10
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: July 31, 2013
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Non-Hodgkin Lymphoma

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Quality of life	Compare mood disturbance and quality of life in those who receive music therapy and those who do not.	7 days	No
Secondary	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	No
Secondary	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	No