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Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02269527
Recruitment Status : Recruiting
First Posted : October 21, 2014
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Joanne Loewy, Icahn School of Medicine at Mount Sinai

Brief Summary:
The use of live music in SICU might affect the perception of noise, which may reduce staff's stress level and further decrease the possibility of clinical errors, reduce patient's anxiety and perception of pain as well as increase compliance from patient and family. Live music might also enhance the quality of stay and promote a holistic healing process for the patient.

Condition or disease Intervention/treatment Phase
Pain Anxiety Stress Other: Live music Not Applicable

Detailed Description:
In this study, the research team is looking at the effect of the live music provided by a trained music therapist, created through incorporating the noises in the SICU - such as the beeping of the machines as part of the elements in the music, to organize the sound environment as well as introducing familiar songs, chosen according to the cultures and ages of the patients, caregivers and staff, to increase a sense of familiarity and comfort. Through the intervention, the research team hope to ameliorate the effects of a noxious sound environment, which may reduce the stress level of the staff and increase their acuity level while decrease patients and caregivers' anxiety level and improve their mood state and the quality of hospitalization

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 318 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of an Integrative Music Therapy Program on the Perception of Noise in the SICU: A Patient, Caregiver, and Physician/Nursing Environmental Study
Study Start Date : June 2010
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Live music
1-hour live music 5 days/week
Other: Live music
Providing 1-hour live music 5 days/ week.




Primary Outcome Measures :
  1. Self-report stress level from SICU staff [ Time Frame: 6 months ]
    Environmental music therapy will reduce stress level for SICU staff.

  2. Pre and Post-intervention score on the perception of SICU noises from SICU and Hospital Anxiety and Depression Scale for SICU patients [ Time Frame: 1 week ]
    Environmental Music Therapy will ameliorate the perception of noises and decrease the anxiety level of SICU patients and caregivers

  3. Pre and Post-intervention score on the perception of SICU noises from SICU patients, caregivers [ Time Frame: 1 week ]


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:

  • SICU patients, caregivers, and physicians/nursing staff

Exclusion Criteria:

  • Non-medical Staff

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): NCT02269527


Contacts
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Contact: Gabrielle Bouissou (212) 420-2719 Gabrielle.Bouissou@mountsinai.org
Contact: John Mondanaro 212-420-2722 John.Mondanaro@mountsinai.org

Locations
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United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Principal Investigator: Joanne Loewy, DA         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Joanne Loewy, DA Mount Sinai Beth Israel
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Responsible Party: Joanne Loewy, Associate Clinical Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02269527    
Other Study ID Numbers: GCO 16-0936
IRB 088-10 ( Other Identifier: Beth Israel Medical Center )
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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