Other Clinical Trial - Music Therapy & Hematopoietic Stem Cell Transplant

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hematopoietic Stem Cell Transplant

Clinical Trial Details

NCT number	NCT03378089
Study type	Interventional
Source	Case Comprehensive Cancer Center
Contact
Status	Completed
Phase	N/A
Start date	February 26, 2018
Completion date	June 21, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Music Therapy and Hematopoietic Stem Cell Transplant

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms