Music TherapyNCT06450626
Music Therapy at TMH Infusion Center
A study testing Listening Music Intervention in people with Music Therapy, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Music Therapy
- What is being tested?
- Listening Music Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who have had a prior infusion session with a music therapy intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Lifespan Cancer Institute at The Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: Introduction of a Music-based Intervention for Patients Receiving Infusions at the Lifespan Cancer Institute Infusion Center in the Miriam Hospital
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?
Read more
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.
Read the 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.
- Conditions
- Music Therapy
- Being tested
- Listening Music Intervention
- Keywords
- Chemotherapy, Infusion Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening Music InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Listening Music Intervention | Experimental | Participants listen to 30 minutes of a music playlist of their choice. Receives: Other: Listening Music Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Music Listening Intervention on Common Symptoms Among Patients with Advanced Cancer via the Edmonton Symptom Assessment Scale
The Edmonton Symptom Assessment Scale (ESAS) is now commonly used for symptom screening and longitudinal monitoring in patients seen by palliative care, oncology, nephrology, and other disciplines in both inpatient and outpatient settings. The ESAS is also a valid and reliable tool to assist in the assessment of nine common symptoms experienced by cancer patients. Possibles scores for each symptom range from 0 (no symptom feeling) to 10 (worst symptom feeling)
Measured: Baseline and 30 minutes (after the music listening intervention)
Change from Baseline in Heart Rate After Music Listening Intervention
Heart rate is a physiological vital sign that is routinely taken by nurses before and after infusion sessions but is also a useful indicator of overall health status and relaxation. Heart rate will be measured in heart beats per minute.
Measured: Baseline and 30 minutes (after the music listening intervention)
Change from Baseline in Respiratory Rate After Music Listening Intervention
Respiratory rate is a physiological vital sign that is routinely taken by nurses before and after infusion sessions but is also a useful indicator of overall health status and relaxation. Respiratory rate will be measured in breaths at rest per minute.
Measured: Baseline and 30 minutes (after the music listening intervention)
Change from Baseline in Blood Pressure After Music Listening Intervention
Blood pressure is a physiological vital sign that is routinely taken by nurses before and after infusion sessions but is also a useful indicator of overall health status and relaxation. Blood pressure will be measured in mmHg.
Measured: Baseline and 30 minutes (after the music listening intervention)
Qualitative Satisfaction Level After Music Listening Intervention
Vetted questions with the study director, Dr. Fred Schiffman, serve to measure participant satisfaction with the music listening intervention and if the experience improved their hospital stay. The questions also ask participants to reflect on any pieces of music that particularly connected with them during their infusion experience and why.
These questions are qualitative in nature so there are no associated scales nor minimum and maximum values.
Measured: Baseline and 30 minutes (after the music listening intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start19 Jun 2024
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- The Warren Alpert Medical School of Brown University
- Responsible party
- Sponsor
- Investigators
- Fred J Schiffman, MD, Study director, Brown UniversityDiana A Wang, BA, Principal investigator, Brown UniversityClaire Lin, BA, Principal investigator, Brown UniversityIshaani Khatri, BA, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06450626
- Sponsor's protocol ID
- STUDY00000448
- Status last verified
- Jan 2025
- First submitted
- 31 May 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers. All collected data will be kept internal to researchers on the project.
Publications
Khatri IS, Wang D, Lin C, Schiffman F, Guyer D. Infusion of Sound: Personalized Receptive Music-Based Intervention (rMBI) During Infusion Sessions. J Palliat Med. 2026 Apr;29(4):488-494. doi: 10.1177/10966218251406793. Epub 2025 Dec 12.
PubMed 41467890
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introduction of a Music-based Intervention for Patients Receiving Infusions at the Lifespan Cancer Institute Infusion Center in the Miriam Hospital
- ClinicalTrials.gov ID
- NCT06450626
- Acronym / sponsor ID
- STUDY00000448
- Conditions
- Music Therapy
- Keywords
- Chemotherapy, Infusion Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- The Warren Alpert Medical School of Brown University
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Listening Music Intervention | Experimental | Other: Listening Music InterventionParticipants listen to 30 minutes of a music playlist of their choice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who have had a prior infusion session with a music therapy intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Listening Music InterventionParticipants 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. | Other | Listening Music Intervention |
Primary outcome
Effect of Music Listening Intervention on Common Symptoms Among Patients with Advanced Cancer via the Edmonton Symptom Assessment Scale
Time frame: Baseline and 30 minutes (after the music listening intervention)
The Edmonton Symptom Assessment Scale (ESAS) is now commonly used for symptom screening and longitudinal monitoring in patients seen by palliative care, oncology, nephrology, and other disciplines in both inpatient and outpatient settings. The ESAS is also a valid and reliable tool to assist in the assessment of nine common symptoms experienced by cancer patients. Possibles scores for each symptom range from 0 (no symptom feeling) to 10 (worst symptom feeling)
Change from Baseline in Heart Rate After Music Listening Intervention
Time frame: Baseline and 30 minutes (after the music listening intervention)
Heart rate is a physiological vital sign that is routinely taken by nurses before and after infusion sessions but is also a useful indicator of overall health status and relaxation. Heart rate will be measured in heart beats per minute.
Change from Baseline in Respiratory Rate After Music Listening Intervention
Time frame: Baseline and 30 minutes (after the music listening intervention)
Respiratory rate is a physiological vital sign that is routinely taken by nurses before and after infusion sessions but is also a useful indicator of overall health status and relaxation. Respiratory rate will be measured in breaths at rest per minute.
Change from Baseline in Blood Pressure After Music Listening Intervention
Time frame: Baseline and 30 minutes (after the music listening intervention)
Blood pressure is a physiological vital sign that is routinely taken by nurses before and after infusion sessions but is also a useful indicator of overall health status and relaxation. Blood pressure will be measured in mmHg.
Qualitative Satisfaction Level After Music Listening Intervention
Time frame: Baseline and 30 minutes (after the music listening intervention)
Vetted questions with the study director, Dr. Fred Schiffman, serve to measure participant satisfaction with the music listening intervention and if the experience improved their hospital stay. The questions also ask participants to reflect on any pieces of music that particularly connected with them during their infusion experience and why. These questions are qualitative in nature so there are no associated scales nor minimum and maximum values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 41467890Khatri IS, Wang D, Lin C, Schiffman F, Guyer D. Infusion of Sound: Personalized Receptive Music-Based Intervention (rMBI) During Infusion Sessions. J Palliat Med. 2026 Apr;29(4):488-494. doi: 10.1177/10966218251406793. Epub 2025 Dec 12.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers. All collected data will be kept internal to researchers on the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fred J Schiffman, MD study director
Brown University
Diana A Wang, BA principal investigator
Brown University
Claire Lin, BA principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening Music Intervention in people with Music Therapy, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Music Listening Intervention on Common Symptoms Among Patients with Advanced Cancer via the Edmonton Symptom Assessment Scale (time frame: Baseline and 30 minutes (after the music listening intervention)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06450626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.