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Trial record 1 of 1 for:    music therapy | infusion | United States
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Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy

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ClinicalTrials.gov Identifier: NCT02261558
Recruitment Status : Recruiting
First Posted : October 10, 2014
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Beth Israel Medical Center

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).

Condition or disease Intervention/treatment Phase
Anxiety Other: Clinical Improvisation Instrumental Music Therapy Other: Clinical Vocal Improvisation Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Clinical Music Improvisation on Resiliency in Adults Undergoing Infusion Therapy
Study Start Date : June 2011
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Clinical Improvisation Instrumental Music Therapy
Clinical Music Therapy session, 20 minutes. Focus on instrumental improvisation
Other: Clinical Improvisation Instrumental Music Therapy
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
Other: Clinical 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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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."

  4. 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."

  5. 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."

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Under 18
  • past cancer(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261558


Contacts
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Contact: Reynaldo Pulido, MMT 212-420-3592 reynaldopulido@chpnet.org

Locations
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United States, New York
Beth Israel Medical Center Recruiting
New York, New York, United States, 10003
Principal Investigator: Joanne Loewy, DA         
Sponsors and Collaborators
Beth Israel Medical Center
Investigators
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Principal Investigator: Joanne Loewy, MT-BC Mount Sinai Beth Israel

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Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02261558     History of Changes
Other Study ID Numbers: 09-090
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017