NCT02269527

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2020

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

9.8 years

First QC Date

May 27, 2014

Last Update Submit

February 13, 2024

Conditions

PainAnxietyStress

Outcome Measures

Primary Outcomes (3)

  • Self-report stress level from SICU staff

    Environmental music therapy will reduce stress level for SICU staff.

    6 months

  • Pre and Post-intervention score on the perception of SICU noises from SICU and Hospital Anxiety and Depression Scale for SICU patients

    Environmental Music Therapy will ameliorate the perception of noises and decrease the anxiety level of SICU patients and caregivers

    1 week

  • Pre and Post-intervention score on the perception of SICU noises from SICU patients, caregivers

    1 week

Study Arms (1)

Live music

OTHER

1-hour live music 5 days/week

Other: Live music

Interventions

Live musicOTHER

Providing 1-hour live music 5 days/ week.

Live music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SICU patients, caregivers, and physicians/nursing staff

You may not qualify if:

  • Non-medical Staff

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Joanne Loewy, DA

    Mount Sinai Union Square

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Clinical Professor

Study Record Dates

First Submitted

May 27, 2014

First Posted

October 21, 2014

Study Start

June 1, 2010

Primary Completion

March 2, 2020

Study Completion

March 2, 2020

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations

US(1)