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

November 14, 2019 updated by: Mohamed Fakher, Cairo University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Giza, Cairo, Egypt, 12613
        • Mohamed Amin Fakher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • confused patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music exposure
will be exposed to music to investigate effects on preventing noise Adverse effects
Other: music
exposure to music to investigate its effects on reducing noise adverse effects
No Intervention: Control
no exposure to music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month
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
in hospital up to 2 months
Burnout syndrome
Time Frame: 1 month
Occurrence of burnout syndrome in healthcare personnel
1 month
Depression symptoms
Time Frame: 1 month
Occurrence of depression symptoms in healthcare personnel assessed by becks tool
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of stay in icu
Time Frame: in hospital 1 year
Length of patient stay in the ICU
in hospital 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 9, 2019

Primary Completion (Anticipated)

December 5, 2019

Study Completion (Anticipated)

December 5, 2019

Study Registration Dates

First Submitted

November 7, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-15-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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