The Effect of EMT on Anxiety Levels and Perception of Waiting Time in the Radiation Oncology Waiting Room

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Environmental Music Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Downtown Union Square

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Waiting Time	Perception of waiting time questionnaire	Day 1

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Study Chair: Andrew Rossetti, MMT, Icahn School of Medicine at Mount Sinai; Principal Investigator: Joanne Loewy, DA, Icahn School of Medicine at Mount Sinai

Publications and helpful links

Helpful Links

• More information

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2012
• Primary Completion (Actual): March 26, 2019
• Study Completion (Actual): March 26, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: anxiety; music therapy; EMT; radiation oncology; environmental music therapy; waiting room
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GCO 16-1190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No