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Trial Title:
Music Therapy at TMH Infusion Center
NCT ID:
NCT06450626
Condition:
Music Therapy
Conditions: Keywords:
Chemotherapy
Infusion Therapy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Listening Music Intervention
Description:
Participants will listen to a music playlist while vitals are monitored, along with
completing a pre- and post-assessment survey (both of which are the Edmonton Symptom
Assessment Scale). Participants will also be asked a set of qualitative questions about
their overall experience with the music therapy session.
Arm group label:
Listening Music Intervention
Summary:
The goal of this clinical trial is to test the effects of a listening music intervention
on the symptom burden carried by patients who are receiving infusions at the Lifespan
Cancer Institute of Miriam Hospital in Providence, Rhode Island. The main questions it
aims to answer are:
- Will a music therapy intervention help reduce physical and mental symptom burden?
- Will a music therapy intervention be beneficial on physiological parameters during
the infusion sessions, such as heart rate, respiratory rate, and blood rate?
Participants will undergo the following main tasks:
- Prior to the infusion, participants will be given a pre-assessment survey reflecting
on their previous experiences with infusions.
- During the infusion, participants will listen to a self-selected playlist either on
their own device or on an iPad provided by the clinic, and vitals will be monitored.
- After the session, participants will be given a post-assessment survey to evaluate
outcomes of the intervention.
- Participants will also be asked a set of qualitative questions about their overall
experience with the music therapy session.
Detailed description:
An estimated 17 million Americans are living with cancer, and the majority receive
chemotherapy annually, which, in addition to common side effects like pain, fatigue,
nausea, vomiting, and hair loss, also imposes a significant psychological and emotional
toll on patients. Studies consistently show a high prevalence of depression and anxiety
among cancer patients due to both the disease and the therapeutic burden, with prolonged
chemotherapy being a particularly significant risk factor. This underscores the need for
nonpharmacological and non-invasive treatments to reduce the negative emotional states,
psychological burden, and stress that often accompany chemotherapy. Music therapy has
increasingly been utilized in clinical settings as a complementary intervention,
benefiting various populations, including those with dementia-related disorders, by
treating cognitive and behavioral symptoms through social interaction and other acute
benefits. Passive music therapy, such as listening to recorded or live music, has been
shown to ease psychosocial symptoms, even in the absence of a trained music therapist.
Overall, music therapy promotes wellness, manages stress, alleviates pain, enhances
memory, improves communication, and supports physical rehabilitation. For instance, in
hypertensive young adults, four weeks of passive music therapy significantly lowered
systolic blood pressure and heart rate, suggesting a soothing and rehabilitative effect.
Additionally, singing along to music boosts cytokine levels, indicating strengthened
immunity through improved mood and reduced stress. Music therapy research supports its
benefits for cancer patients, as studies have shown improved mood, reduced distress,
increased resilience, and decreased anxiety and heart rate during chemotherapy. Despite
these demonstrated benefits, music therapy services are under-resourced, particularly in
Rhode Island, where only one licensed music therapist was reported in 2020, serving
around 2000 clients across eight facilities. This project aims to implement a music
therapy program at Miriam Hospital to enhance the well-being of chemotherapy patients and
potentially expand to other Lifespan Infusion Centers in Rhode Island, such as Rhode
Island Hospital and Newport Hospital. Given the lack of structured music therapy programs
for oncology patients in Rhode Island, this initiative seeks to establish a formal music
therapy offering at Miriam Hospital, setting the stage for broader adoption and
integration of music therapy in cancer care across the state.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Sufficient hearing capacity to hear music
- Scheduled for a chemotherapy infusion lasting at least 30 minutes
- Ability to complete pre- and post-assessments in English
Exclusion Criteria:
- Participants who have had a prior infusion session with a music therapy intervention
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Lifespan Cancer Institute at The Miriam Hospital
Address:
City:
Providence
Zip:
02906
Country:
United States
Status:
Recruiting
Contact:
Last name:
Fred J Schiffman, MD
Email:
fschiffman@lifespan.org
Start date:
June 19, 2024
Completion date:
December 2024
Lead sponsor:
Agency:
Brown University
Agency class:
Other
Collaborator:
Agency:
The Warren Alpert Medical School of Brown University
Agency class:
Other
Source:
Brown University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06450626