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 : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Environmental Music Therapy||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|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)|
|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|
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.
- 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
- 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
- Perceived Waiting Time [ Time Frame: Day 1 ]Perception of waiting time questionnaire
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
|United States, New York|
|Mount Sinai Downtown Union Square|
|New York, New York, United States, 10003|
|Study Chair:||Andrew Rossetti, MMT||Icahn School of Medicine at Mount Sinai|
|Principal Investigator:||Joanne Loewy, DA||Icahn School of Medicine at Mount Sinai|