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

NCT03660319 | Completed

• 1 other identifier: GCO 16-1190
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

music therapy; EMT; environmental music therapy; radiation oncology; anxiety; waiting room

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Perceived Waiting Time

  Day 1

Study Arms (2)

Environmental Music Therapy

EXPERIMENTAL

Music Therapy Intervention (EMT)

Other: Environmental Music Therapy

Control

NO INTERVENTION

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

Interventions

Environmental Music Therapy OTHER

Experiencing Environmental Music Therapy during wait time in radiation oncology waiting room.

Also known as: Music Therapy Intervention

Environmental Music Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Downtown Union Square

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Andrew Rossetti, MMT

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

• Joanne Loewy, DA

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized into two groups: Music Therapy Intervention (Environmental Music Therapy) and Control arm with no Music Therapy.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: November 20, 2012
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)