Clinical trial NCT02261558: Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy
Official title: Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate the impact of music therapy on newly diagnosed patients with cancer undergoing chemotherapy. Measurements used at baseline, middle and end of first cycle will be the Resiliency Scale (Wagnild and Young 1993); The HADS scale (hospital anxiety depression scale, Zigmond and Snaith 1983 )and and The CAS scale for pain (Color Analysis Scale).

Detailed description: The purpose of this research study is to examine clinical music therapy's impact on the resiliency of adults undergoing infusion therapy. This research study is being undertaken to learn about how creative music therapy modalities can affect the infusion therapy process. Infusion therapy often includes side effects which impact quality of life. Symptoms include pain, nausea and anxiety. For newly diagnosed patients anxiety accompanies adjustment to scheduling treatments and side effects. Typically patients receiving infusion therapy have no alternative focus for their mind and or body aside from the Infusion itself. Since the relationship between pain and anxiety is inter-related, altering one modality through a live music intervention may modify the impact of the other modality thus shifting the cycle and overall impact of pain and anxiety providing relief which leads to self soothing control measures. The current research will enroll patients newly diagnosed with either Lung, Breast, or Gastrointestinal Cancer that are treated in the Infusion Suite of SLRHC. 100 patients will be randomly assigned to three groups: clinical instrumental improvisation, clinical vocal improvisation or control. All enrolled participants will complete a survey which indicates their music preference, Resiliency Test , the Hospital Anxiety and Depression Scale (HADS), Visual Analogue Scale (VAS), and Body Pain Scale - Color Analysis Scale (CAS).

Eligibility criteria: Inclusion Criteria:

* 18 and older
* diagnosed with breast cancer, lung cancer, or gastro-intestinal cancer

Exclusion Criteria:

* Under 18
* past cancer(s)

Primary outcomes:
measure: Resiliency Scale
timeFrame: At 6 months
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: At 6 months
measure: Music Psychotherapy Data Tool
timeFrame: At 6 months
measure: Visual Analogue Scale (VAS)
timeFrame: At 1 month
measure: Visual Analogue Scale (VAS)
timeFrame: At 3 months
measure: Visual Analogue Scale (VAS)
timeFrame: At 6 months
measure: Body Pain Scale - Color Analysis Scale (CAS)
timeFrame: At 1 month
measure: Body Pain Scale - Color Analysis Scale (CAS)
timeFrame: At 3 months
measure: Body Pain Scale - Color Analysis Scale (CAS)
timeFrame: At 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
Study officials:
affiliation: Mount Sinai Beth Israel
name: Joanne Loewy, MT-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bradt J, Dileo C, Myers-Coffman K, Biondo J. Music interventions for improving psychological and physical outcomes in people with cancer. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD006911. doi: 10.1002/14651858.CD006911.pub4.
citation: Mondanaro JF, Sara GA, Thachil R, Pranjic M, Rossetti A, EunHye Sim G, Canga B, Harrison IB, Loewy JV. The Effects of Clinical Music Therapy on Resiliency in Adults Undergoing Infusion: A Randomized, Controlled Trial. J Pain Symptom Manage. 2021 Jun;61(6):1099-1108. doi: 10.1016/j.jpainsymman.2020.10.032. Epub 2020 Nov 2.