- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261558
Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy
January 28, 2020 updated by: Beth Israel Medical Center
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
176
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Beth Israel Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 and older
- diagnosed with breast cancer, lung cancer, or gastro-intestinal cancer
Exclusion Criteria:
- Under 18
- past cancer(s)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Clinical Improvisation Instrumental Music Therapy
Clinical Music Therapy session, 20 minutes.
Focus on instrumental improvisation
|
Select an instrument of choice (and instruments for caregiver/s if applicable) Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music.
Closure through verbal reflection and sharing (5 minutes)
|
EXPERIMENTAL: Clinical Vocal Improvisation
Clinical Music Therapy session, 20 minutes.
Focus on vocal improvisation
|
* 5 minutes of warm up.
Select a few favorite songs of choice.
Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music.
Identify themes and issues addressed and/or paralleled in the song and/or within the self Closure through verbal reflection and sharing (5 minutes)
|
NO_INTERVENTION: Control Group
Participants enrolled in control group will complete the same study design, without having a clinical music improvisation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resiliency Scale
Time Frame: At 6 months
|
Research indicates that the majority of patients undergoing chemotherapy have extreme anxiety, particularly in the first round. .
The music therapy implemented in the 2 treatment arms will be live and evaluated to meet the patients' culture, past medical history, past trauma upon assessment of psychological stressors.
Resilience as measured through quantitative scale Wagnild, & Young (1993) that views daily activities and coping strategies that are often compromised with diseases that require frequent treatments.
|
At 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: At 6 months
|
The HADS provides entry and final treatment endurance in coping strategies related to anxiety and depression during disease treatment trajectories.
|
At 6 months
|
Music Psychotherapy Data Tool
Time Frame: At 6 months
|
An informative questioner regarding the participant's musical preferences- favorite genres, artists or songs, and music history ( if applicable)- exposure to music through family members, and/or history of participation in a musical activity (such as social or private classes)
|
At 6 months
|
Visual Analogue Scale (VAS)
Time Frame: At 1 month
|
The VAS is a single-item scale.A unidimensional measure of pain and stress intensity.
A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale.
Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
|
At 1 month
|
Visual Analogue Scale (VAS)
Time Frame: At 3 months
|
The VAS is a single-item scale.A unidimensional measure of pain and stress intensity.
A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale.
Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
|
At 3 months
|
Visual Analogue Scale (VAS)
Time Frame: At 6 months
|
The VAS is a single-item scale.A unidimensional measure of pain and stress intensity.
A continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, includes 5 levels of stress/pain (0,2,4,6,8,10), anchored by 2 verbal descriptors, one for each symptom extreme (no stress to worst possible stress).Tthe patient indicates the degree of stress he/she experiences by choosing one of the 5 levels on the scale.
Respondents are asked to report "current" pain/stress intensity or "in the last 24 hours."
|
At 6 months
|
Body Pain Scale - Color Analysis Scale (CAS)
Time Frame: At 1 month
|
An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure .
The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
|
At 1 month
|
Body Pain Scale - Color Analysis Scale (CAS)
Time Frame: At 3 months
|
An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure .
The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
|
At 3 months
|
Body Pain Scale - Color Analysis Scale (CAS)
Time Frame: At 6 months
|
An evaluative rating for pain, which offers the expression of pain through the patient's visual depiction, using crayon illustration on a sketch of a body figure .
The participants are provided with a framed body figure, matched to their gender, including front and back of the body, in order for the participants to depict their pain experience with color.
|
At 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanne Loewy, MT-BC, Mount Sinai Beth Israel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (ACTUAL)
April 1, 2019
Study Completion (ACTUAL)
April 1, 2019
Study Registration Dates
First Submitted
July 24, 2014
First Submitted That Met QC Criteria
October 7, 2014
First Posted (ESTIMATE)
October 10, 2014
Study Record Updates
Last Update Posted (ACTUAL)
January 30, 2020
Last Update Submitted That Met QC Criteria
January 28, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- GCO 16-0838
- 09-090 (Beth Israel Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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