NCT03378089

Music Therapy and Hematopoietic Stem Cell Transplant

The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized, controlled study is to determine the effects of pre-transplant music therapy on mood, distress, and physical functioning variables in patients undergoing Hematopoietic Stem Cell Transplant (HSCT).

Detailed description

Primary Endpoint: Compare the difference in distress via Distress Thermometer for patients who receive music therapy and those who do not. Secondary Endpoints: Compare the difference in patient perception of pain, anxiety, and mood via Numeric Rating Scale for patients who receive music therapy and those who do not. Compare the difference in quality of life via Functional Assessment of Cancer Therapy-General (FACT-G7) for patients who receive music therapy and those who do not. Compare the difference in the use of total narcotic medications in those who receive music therapy and those who do not (using morphine equivalent doses). Study Design: Participants randomized in the experimental group will receive a total of three sessions prior to stem cell infusion day. The first session will occur within 24 hours of admission to the bone marrow transplant (BMT) unit. The second session will occur between 24 - 96 hours after the first session, depending on transplant preparation regimen. The third session will occur on Day -1. For participants in the control group, assessments will be timed to emulate those in the experimental arm. A decision tree for music therapy interventions will be employed in this study. Participants in the experimental group will be given choices about how to proceed with the session: active or passive, improvisation, re-creative or receptive songs, or receptive (relaxation). Participants randomized to the standard care group will be asked to rate the same symptoms as those in the experimental group. This will mark the beginning of a 45-minute control condition period during which the participants may fill the 45-minute time-period in whatever ways they choose, however, they will be asked to refrain from listening to recorded music during this time. At the conclusion of 45-minutes, post-condition data will be collected.

Conditions

• Hematopoietic Stem Cell Transplant

Interventions

Type	Name	Description
BEHAVIORAL	Music Therapy	No narcotic or anti-emetic therapy will be administered for at least 2 hours prior to music therapy session. Music therapy sessions will be administered by a board certified music therapist (MT-BC) and last approximately 45 minutes. Involvement in sessions will be based on therapist and patient availability.
BEHAVIORAL	No Music Therapy	Participants will fill the same 45 minute period in any way they choose; however, they will be asked to refrain from listening to recorded music during this time.

Timeline

• Start date: 2018-02-26
• Primary completion: 2019-06-21
• Completion: 2019-06-21
• First posted: 2017-12-19
• Last updated: 2019-08-01

Locations

1 site across 1 country: United States