Music Therapy at TMH Infusion Center

NCT06450626 | Completed

• 1 other identifier: STUDY00000448
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Music Therapy

Keywords

Chemotherapy; Infusion Therapy

Outcome Measures

Primary Outcomes (5)

• 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)

  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.

  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.

  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.

  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.

  Baseline and 30 minutes (after the music listening intervention)

Study Arms (1)

Listening Music Intervention

EXPERIMENTAL

Participants listen to 30 minutes of a music playlist of their choice.

Other: Listening Music Intervention

Interventions

Listening Music Intervention OTHER

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.

Listening Music Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants who have had a prior infusion session with a music therapy intervention

Sponsors & Collaborators

• Brown University: lead
• The Warren Alpert Medical School of Brown University: collaborator

Study Sites (1)

Lifespan Cancer Institute at The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• 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. 2025 Dec 12. doi: 10.1177/10966218251406793. Online ahead of print.

  PMID: 41467890 DERIVED

Study Officials

• Fred J Schiffman, MD

  Brown University

  STUDY DIRECTOR

• Diana A Wang, BA

  Brown University

  PRINCIPAL INVESTIGATOR

• Claire Lin, BA

  Brown University

  PRINCIPAL INVESTIGATOR

• Ishaani Khatri, BA

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 10, 2024
• Study Start: June 19, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)