Back to resultsNoise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
Primary Purpose
Noise; Adverse Effect
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
music
Sponsored by
About this trial
This is an interventional prevention trial for Noise; Adverse Effect focused on measuring Noise ICU, delirium, depression, burnout, music
Eligibility Criteria
Inclusion Criteria:
- patients admitted to ICU fully conscious and can answer the questionnaires of the study
Exclusion Criteria:
- confused patients
Sites / Locations
- Mohamed Amin Fakher
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music exposure
Control
Arm Description
will be exposed to music to investigate effects on preventing noise Adverse effects
no exposure to music
Outcomes
Primary Outcome Measures
sleep quality: Richard Campbell sleep questionnaire
Richard Campbell sleep questionnaire will be used A modified 6 question questionnaire each question from 0 to 100
delirium
Confusion Assessment Method flow sheet in ICU (CAM -ICU too)l will be used 4 questions flow sheet
Burnout syndrome
Occurrence of burnout syndrome in healthcare personnel
Depression symptoms
Occurrence of depression symptoms in healthcare personnel assessed by becks tool
Secondary Outcome Measures
length of stay in icu
Length of patient stay in the ICU
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04164498
Brief Title
Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
Official Title
Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2019 (Anticipated)
Primary Completion Date
December 5, 2019 (Anticipated)
Study Completion Date
December 5, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise; Adverse Effect
Keywords
Noise ICU, delirium, depression, burnout, music
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music exposure
Arm Type
Experimental
Arm Description
will be exposed to music to investigate effects on preventing noise Adverse effects
Arm Title
Control
Arm Type
No Intervention
Arm Description
no exposure to music
Intervention Type
Other
Intervention Name(s)
music
Intervention Description
exposure to music to investigate its effects on reducing noise adverse effects
Primary Outcome Measure Information:
Title
sleep quality: Richard Campbell sleep questionnaire
Description
Richard Campbell sleep questionnaire will be used A modified 6 question questionnaire each question from 0 to 100
Time Frame
1 month
Title
delirium
Description
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
Title
Burnout syndrome
Description
Occurrence of burnout syndrome in healthcare personnel
Time Frame
1 month
Title
Depression symptoms
Description
Occurrence of depression symptoms in healthcare personnel assessed by becks tool
Time Frame
1 month
Secondary Outcome Measure Information:
Title
length of stay in icu
Description
Length of patient stay in the ICU
Time Frame
in hospital 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients admitted to ICU fully conscious and can answer the questionnaires of the study
Exclusion Criteria:
confused patients
Facility Information:
Facility Name
Mohamed Amin Fakher
City
Giza
State/Province
Cairo
ZIP/Postal Code
12613
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Noise in Critical Care Units.Impact on Critically Ill Patients and Healthcare Personnel
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