Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450626
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-05-31
Brief Title:
Music Therapy at TMH Infusion Center
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Introduction of a Music-based Intervention for Patients Receiving Infusions at the Lifespan Cancer Institute Infusion Center in the Miriam Hospital
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None