Noise; Adverse EffectNCT04164498
Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
A study testing music in people with Noise; Adverse Effect, run by Cairo University at 1 site in Egypt.
Trial summary
Study noise level in the ICU and its effect on both patients and healthcare personnel. Use music and study same effects on same patients and healthcare personnel. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Noise; Adverse Effect
- What is being tested?
- music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Nov 2019to 5 Dec 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients admitted to ICU fully conscious and can answer the questionnaires of the study
Who cannot join
- confused patients
Trial locations and contacts
1 site in 1 country.
About this study
Study noise level in the ICU and its effect on both patients and healthcare personnel.
Use music and study same effects on same patients and healthcare personnel.
Read the detailed description
Level of noise is measured and investigate its effects on delirium prevalence. sleep quality score. hemodynamics of patients.
burnout and depressive symptoms of healthcare personnel
- Conditions
- Noise; Adverse Effect
- Being tested
- music
- Keywords
- Noise ICU, delirium, depression, burnout, music
- Medical subject headings
- Delirium, Depression, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
exposure to music to investigate its effects on reducing noise adverse effects
| Study group | Role | What they receive |
|---|---|---|
| Music exposure | Experimental | will be exposed to music to investigate effects on preventing noise Adverse effects Receives: Other: music |
| Control | No intervention | no exposure to music |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality: Richard Campbell sleep questionnaire
Richard Campbell sleep questionnaire will be used A modified 6 question questionnaire each question from 0 to 100
Measured: 1 month
delirium
Confusion Assessment Method flow sheet in ICU (CAM -ICU too)l will be used 4 questions flow sheet
Measured: in hospital up to 2 months
Burnout syndrome
Occurrence of burnout syndrome in healthcare personnel
Measured: 1 month
Depression symptoms
Occurrence of depression symptoms in healthcare personnel assessed by becks tool
Measured: 1 month
Secondary outcomes (1)
length of stay in icu
Length of patient stay in the ICU
Measured: in hospital 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start9 Nov 2019 (estimated)
- Primary completion5 Dec 2019 (estimated)
- Study completion5 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Noise; Adverse EffectStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakher, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164498
- Sponsor's protocol ID
- S-15-2019
- Status last verified
- Nov 2019
- First submitted
- 7 Nov 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
- ClinicalTrials.gov ID
- NCT04164498
- Acronym / sponsor ID
- S-15-2019
- Conditions
- Noise; Adverse Effect
- Keywords
- Noise ICU, delirium, depression, burnout, music
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Nov 2019 (estimated)
- Primary completion
- 5 Dec 2019 (estimated)
- Study completion
- 5 Dec 2019 (estimated)
- First posted
- 15 Nov 2019 (actual)
- 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.
Study noise level in the ICU and its effect on both patients and healthcare personnel.
Use music and study same effects on same patients and healthcare personnel.
Detailed description
Level of noise is measured and investigate its effects on delirium prevalence. sleep quality score. hemodynamics of patients.
burnout and depressive symptoms of healthcare personnel
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music exposure | Experimental | Other: musicwill be exposed to music to investigate effects on preventing noise Adverse effects |
| Control | No intervention | –no exposure to music |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients admitted to ICU fully conscious and can answer the questionnaires of the study
Key exclusion criteria (1 listed)
- confused patients
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 |
|---|---|---|
| musicexposure to music to investigate its effects on reducing noise adverse effects | Other | Music exposure |
Primary outcome
sleep quality: Richard Campbell sleep questionnaire
Time frame: 1 month
Richard Campbell sleep questionnaire will be used A modified 6 question questionnaire each question from 0 to 100
delirium
Time frame: in hospital up to 2 months
Confusion Assessment Method flow sheet in ICU (CAM -ICU too)l will be used 4 questions flow sheet
Burnout syndrome
Time frame: 1 month
Occurrence of burnout syndrome in healthcare personnel
Depression symptoms
Time frame: 1 month
Occurrence of depression symptoms in healthcare personnel assessed by becks tool
1 secondary outcome
length of stay in icu
Time frame: in hospital 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music in people with Noise; Adverse Effect, run by Cairo University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 15 Nov 2019. 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 Egypt. 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?
Results are not available in the source record.
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?
sleep quality: Richard Campbell sleep questionnaire (time frame: 1 month). The study lists 4 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 15 Nov 2019.