NCT04164498

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

26 days

First QC Date

November 7, 2019

Last Update Submit

November 14, 2019

Conditions

Noise; Adverse Effect

Keywords

Noise ICUdeliriumdepressionburnoutmusic

Outcome Measures

Primary Outcomes (4)

  • sleep quality: Richard Campbell sleep questionnaire

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

    1 month

  • delirium

    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

    Occurrence of burnout syndrome in healthcare personnel

    1 month

  • Depression symptoms

    Occurrence of depression symptoms in healthcare personnel assessed by becks tool

    1 month

Secondary Outcomes (1)

  • length of stay in icu

    in hospital 1 year

Study Arms (2)

Music exposure

EXPERIMENTAL

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

Other: music

Control

NO INTERVENTION

no exposure to music

Interventions

musicOTHER

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

Music exposure

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • confused patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Amin Fakher

Giza, Cairo Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

DeliriumDepressionBurnout, Psychological

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBehavioral SymptomsBehaviorStress, Psychological

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor(lecturer)

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 15, 2019

Study Start

November 9, 2019

Primary Completion

December 5, 2019

Study Completion

December 5, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)