Cancer Clinical Trial
Official title:
The Effect of EMT on Anxiety Levels and Perception of Waiting Time in the Radiation Oncology Waiting Room
Verified date | June 2020 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be investigating the effects of environmental music therapy (EMT) on patient and caregiver anxiety levels and perceptions of waiting time for patients undergoing radiation therapy. Environmental music therapy is live music offered by a music therapist with the intention of modifying patients' and caregivers' perception of the environment itself and in so doing provide an experience of enhanced comfort and relaxation. One hundred and sixty patients and their caregivers, when present, who are diagnosed with Cancer, including head & neck, breast, prostate, lymphoma, gastro-intestinal, and skin cancers, as well as other cancers will be identified and referred by Mount Sinai Downtown radiation oncology attending doctors prior to their arrival in the waiting room of the Radiation Oncology Suite. All Cancer subjects will be considered regardless of gender or racial/ethnic background, and health status with the exception of those less than 18 years of age. Only patients who are fluent in English will be eligible to enroll in the study. Patients will randomly be assigned to the control or environmental music group. The patients in the control group will be able to receive music therapy during radiation therapy, even though they will not have music therapy during their waiting room time, as is the focus of this study.
Status | Completed |
Enrollment | 160 |
Est. completion date | March 26, 2019 |
Est. primary completion date | March 26, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years or older - Receiving treatment for cancer in the radiation oncology department - Personal caregivers of patients receiving treatment for care in the radiation oncology department Exclusion Criteria: - Adults who are not fluent in English - Adults unable to consent - Individuals who are not yet adults (e.g. infants, children, teenagers) - Wards of the State (e.g. foster children) - Pregnant women - Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai Downtown Union Square | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wong-Baker Faces Scale | Anxiety measured by Wong-Baker Faces Scale during their waiting which has 6 faces with the first face scored 0 (no anxiety) to the last face scored 10 (high anxiety), total scale from 0-10, higher score indicating more anxiety | Day 1 | |
Primary | Short-Form STAI | Anxiety measured by Short-Form STAI during their waiting. Short-Form STAI is a 6-item instrument. To calculate the total STAI score (range 20 - 80): reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; with higher score indicating more anxiety |
Day 1 | |
Secondary | Perceived Waiting Time | Perception of waiting time questionnaire | Day 1 |
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