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Trial record 1 of 1 for:    NCT03660319
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The Effect of EMT on Anxiety Levels and Perception of Waiting Time in the Radiation Oncology Waiting Room

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ClinicalTrials.gov Identifier: NCT03660319
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Other: Environmental Music Therapy Not Applicable

Detailed Description:

Objectives:

Will EMT affectively reduce state anxiety and time distortion in patients receiving radiation therapy for cancer and in their personal caregivers during their time in the radiation oncology department waiting room? The purpose of this study is to (a) rate the patients level of anxiety and discomfort prior to radiation therapy as experienced in the waiting area, (b) determine if the following music psychotherapy protocol moderates baseline anxiety related to their treatment experience and (c) evaluate how an environmental music therapy protocol affects the subjects' perception of the amount of they have waited before treatment measured against the actual amount of time they have waited.

Hypothesis:

EMT will reduce state anxiety and time distortion for cancer patients and their personal caregivers in the radiation oncology waiting room.

The current study will focus on effects of music therapy on 160 patients and their caregivers, who are randomly assigned to two groups. All patients with cancer who receive radiation and who are waiting for radiation therapy in the waiting room are eligible, with the exception of those patients who are not fluent in English. Enrolled participants will complete the abridged State Trait Anxiety Inventory and the Wong-Baker faces scale pre and post EMT or no EMT. The music therapist will provide prescribed live patient-preferred music in conjunction with the patients' culture, past medical history, past trauma, and assessment of psychological stressors to be observed and expressed prior to radiation, as they wait in the waiting room. The live music used will provide an anchor and suggest inter-relationship possibilities amongst patients and their caregivers during the EMT sessions.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants randomized into two groups: Music Therapy Intervention (Environmental Music Therapy) and Control arm with no Music Therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of EMT on Anxiety Levels and Perception of Waiting Time in the Radiation Oncology Waiting Room
Actual Study Start Date : November 20, 2012
Actual Primary Completion Date : March 26, 2019
Actual Study Completion Date : March 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Environmental Music Therapy
Music Therapy Intervention (EMT)
Other: Environmental Music Therapy
Experiencing Environmental Music Therapy during wait time in radiation oncology waiting room.
Other Name: Music Therapy Intervention

No Intervention: Control
Control - No Environmental Music Therapy. Does not experience Environmental Music Therapy during wait time in radiation oncology waiting room.



Primary Outcome Measures :
  1. Wong-Baker Faces Scale [ Time Frame: Day 1 ]
    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

  2. Short-Form STAI [ Time Frame: Day 1 ]

    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


Secondary Outcome Measures :
  1. Perceived Waiting Time [ Time Frame: Day 1 ]
    Perception of waiting time questionnaire



Information from the National Library of Medicine

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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 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

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): NCT03660319


Locations
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United States, New York
Mount Sinai Downtown Union Square
New York, New York, United States, 10003
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Study Chair: Manjeet Chadha, MD Ichan School of Medicine

Additional Information:
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03660319     History of Changes
Other Study ID Numbers: GCO 16-1190
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Icahn School of Medicine at Mount Sinai:
music therapy
EMT
environmental music therapy
radiation oncology
anxiety
waiting room

Additional relevant MeSH terms:
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Neoplasms