CClinicalTrials.gg
Status unknownNCT04164498Updated Nov 15, 2019

Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel

An interventional study of music in Noise; Adverse Effect, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-11-15.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Noise; Adverse Effect

Browse trials for

Keywords

  • Noise ICU
  • delirium
  • depression
  • burnout
  • music
03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 50 is below the median of 90 across 979 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients admitted to ICU fully conscious and can answer the questionnaires of the study

Exclusion criteria

Exclusion Criteria:

  • confused patients
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Music exposure

    will be exposed to music to investigate effects on preventing noise Adverse effects

    Other: music

  • No intervention
    Control

    no exposure to music

Interventions

  • Othermusic

    exposure to music to investigate its effects on reducing noise adverse effects

06

What researchers measure

Primary outcomes

  1. sleep quality: Richard Campbell sleep questionnaire

    Richard Campbell sleep questionnaire will be used A modified 6 question questionnaire each question from 0 to 100

    Time frame: 1 month

  2. delirium

    Confusion Assessment Method flow sheet in ICU (CAM -ICU too)l will be used 4 questions flow sheet

    Time frame: in hospital up to 2 months

  3. Burnout syndrome

    Occurrence of burnout syndrome in healthcare personnel

    Time frame: 1 month

  4. Depression symptoms

    Occurrence of depression symptoms in healthcare personnel assessed by becks tool

    Time frame: 1 month

Secondary outcomes

  1. length of stay in icu

    Length of patient stay in the ICU

    Time frame: in hospital 1 year

07

Study locations

1 site
  • Mohamed Amin Fakher
    Giza, Cairo 12613, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04164498
Lead sponsor
Cairo University
Responsible party
Mohamed Fakher (Assistant professor(lecturer), Cairo University) — Principal investigator
First posted
Nov 15, 2019
Start date
Nov 9, 2019 (estimated)
Primary completion
Dec 5, 2019 (estimated)
Completion
Dec 5, 2019 (estimated)
Last update
Nov 15, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion