Clinical trial NCT03660319: The Effect of EMT on Anxiety Levels and Perception of Waiting Time in the Radiation Oncology Waiting Room
Official title: The Effect of EMT on Anxiety Levels and Perception of Waiting Time in the Radiation Oncology Waiting Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: music therapy
EMT
environmental music therapy
radiation oncology
anxiety
waiting room
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants randomized into two groups: Music Therapy Intervention (Environmental Music Therapy) and Control arm with no Music Therapy.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Wong-Baker Faces Scale
timeFrame: Day 1
measure: Short-Form STAI
timeFrame: Day 1
Secondary outcomes:
measure: Perceived Waiting Time
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Downtown Union Square
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Andrew Rossetti, MMT
role: STUDY_CHAIR
affiliation: Icahn School of Medicine at Mount Sinai
name: Joanne Loewy, DA
role: PRINCIPAL_INVESTIGATOR
References: