PainNCT02269527
Effects of Live Music on the Perception of Noise in the SICU: A Patient, Caregiver, and Medical Staff Environmental Study
A study testing Live music in people with Pain and Anxiety, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Live music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to 2 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SICU patients, caregivers, and physicians/nursing staff
Who cannot join
- Non-medical Staff
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Live music
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live musicOther
Providing 1-hour live music 5 days/ week.
| Study group | Role | What they receive |
|---|---|---|
| Live music | Other | 1-hour live music 5 days/week Receives: Other: Live music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report stress level from SICU staff
Environmental music therapy will reduce stress level for SICU staff.
Measured: 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
Measured: 1 week
Pre and Post-intervention score on the perception of SICU noises from SICU patients, caregivers
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startJun 2010
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanne Loewy, Icahn School of Medicine at Mount Sinai
- Investigators
- Joanne Loewy, DA, Principal investigator, Mount Sinai Union Square
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269527
- Sponsor's protocol ID
- GCO 16-0936
- Other IDs
- IRB 088-10
- Status last verified
- Feb 2024
- First submitted
- 27 May 2014
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02269527
- Acronym / sponsor ID
- GCO 16-0936
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Live music | Other | Other: Live music1-hour live music 5 days/week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SICU patients, caregivers, and physicians/nursing staff
Key exclusion criteria (1 listed)
- Non-medical Staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live musicProviding 1-hour live music 5 days/ week. | Other | Live music |
Primary outcome
Self-report stress level from SICU staff
Time frame: 6 months
Environmental music therapy will reduce stress level for SICU staff.
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
Pre and Post-intervention score on the perception of SICU noises from SICU patients, caregivers
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Loewy, DA principal investigator
Mount Sinai Union Square
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Live music in people with Pain and Anxiety, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report stress level from SICU staff (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.