Music Therapy and Hematopoietic Stem Cell Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | February 26, 2018 |
| End Date: | December 2019 |
| Contact: | Navneet Majhail, MD |
| Email: | majhain@ccf.org |
| Phone: | 216-444-2199 |
The Effects of Pre-Transplant Music Therapy for Patients Undergoing Hematopoietic Stem Cell Transplant
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).
pre-transplant music therapy on mood, distress, and physical functioning variables in
patients undergoing Hematopoietic Stem Cell Transplant (HSCT).
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.
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.
Inclusion Criteria:
- Patients undergoing inpatient allogeneic stem cell transplant
- Must be fluent in English
- Must be able to communicate verbally and have no significant hearing impairment
- Have capacity to provide consent
- All diagnosis, graft source, donor sources will be included.
Exclusion Criteria:
- Patients not meeting the above inclusion criteria
We found this trial at
1
site
Cleveland, Ohio 44195
Principal Investigator: Navneet Majhail, MD
Phone: 216-444-2199
Click here to add this to my saved trials
