Protocol summary

Summary
The main objective of this study was to develop and establish general guidelines on management of intensive care units alarms on alarm fatigue in nurses working in the ICU. In this study the all of nurses working in the general ICU of Namazee Hospital are present. Inclusion criteria is one of the ICU nurses, did not participate in similar research project, willingness to participate in the study and informed consent and eclusion Criteria is unwillingness to continue to cooperate and Ansrf the company in study and did not participate in training sessions. The sample size of this study is 30 items observations that 15 items is before of the intervention and 15 items is after of the intevention. Intervention of this study include education of guidlines of intensive care unit alarms managment that is covering the sections such as the introduction of the alarm fatifue, effects and complications of the alarm fatigue and ways for control and prevention of alarm fatigue. this intervention last about one month.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080818734N1
Registration date: 2015-04-25, 1394/02/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-04-25, 1394/02/05
Registrant information
Name
Amirhossein Yousefinya
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3331 0278
Email address
bayad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Shiraz University of Medical Sciences
Expected recruitment start date
2015-02-08, 1393/11/19
Expected recruitment end date
2016-06-08, 1395/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of development and establishing alarm management guidelines of devices used in the general intensive care unit on alarm fatigue in nurses working in the Shiraz Nammazi hospital, 2014.
Public title
effects of development and establishing alarm management guidelines of devices used in the general intensive care unit on alarm fatigue in nurses
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: one of the ICU nurses; did not participate in similar research project; not affliction known to nurses and mental illnesses such as depression and anxiety disorders; willingness to participate in the study and informed consent. Exclusion Criteria: unwillingness to continue to cooperate and Ansrf the company in study; did not participate in training sessions
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, zand street, Namazi Square, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2015-02-08, 1393/11/19
Ethics committee reference number
CT-9372-7362

Health conditions studied

1

Description of health condition studied
Alarm fatigue in the nurses
ICD-10 code
Y70-Y71-Y7
ICD-10 code description
Cardiovascular devices associated with adverse incidents

Primary outcomes

1

Description
Alarm fatigue in the nurses
Timepoint
Before the intervention - two weaks after the intervention
Method of measurement
Alarm information collection form of the patient monitoring devices

Secondary outcomes

empty

Intervention groups

1

Description
Intervention of this study include education of guidlines of intensive care unit alarms managment that is covering the sections such as the introduction of the alarm fatifue, effects and complications of the alarm fatigue and ways for control and prevention of alarm fatigue that will be trained to nurses in 3 sessions. this intervention last about one month. the venue of workshops will be in conference hall of the Namazee Hospital's general ICU and each workshop will be of 2 hours duration.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
General ICU of the Shiraz Namazee Hospital
Full name of responsible person
Camellia Torabizadeh
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemy
Street address
7th floor, zand street, Namazi Square, Shiraz University of Medical Sciences
City
Shiaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square
Full name of responsible person
Amirhossein Yousefinya
Position
Master of sciense in nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square
City
Shiraz
Postal code
71345-1978
Phone
+98 74 3331 0278
Fax
+98 74 3331 0278
Email
ah.yousefinya@yahoo.com; bayad@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Camelia Torabizadeh
Position
Ph.D in nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3647 4254
Fax
+98 71 3647 4254
Email
torabik@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Camelia Torabizadeh
Position
Ph.D in nursing
Other areas of specialty/work
Street address
Fatemeh(PBUH) School of Nursing and Midwifery, Shiraz University of Medical Science, Namazi Square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3647 4254
Fax
+98 71 3647 4254
Email
torabik@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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