Protocol summary

Study aim
Determining the effect of monitor alarm management training on the level of alarm fatigue of nurses in the intensive care units
Design
A clinical trial with a quasi-experimental design, single group before and after
Settings and conduct
The researcher enters the study setting which is two hospitals in Jahrom city. The target samples include 48 nurses from intensive care units. Sample selection will be done based on the list of nurses and sample size. Informed consent will be obtained after explanation. The intervention is completed within six weeks. ​
Participants/Inclusion and exclusion criteria
1. Willingness to participate in the study 2. Working at least six months in the intensive care unit 3. Not suffering from known neurological and mental diseases 4. Not experiencing a stressful event during the past six months 5. Passing the basic course of training to work with special care units 6. Hearing impairment that prevents the clear hearing of device alarms 7. Experiencing a stressful event during the 12 weeks of the intervention
Intervention groups
Intervention in the first and second week: sending at least 10 five-minute training videos in the messaging group on how to work with the device, focusing on setting the alarms of the devices The third and fourth weeks: face-to-face training of one session per week and updating the contents of two virtual sessions. Repetition of the training session twice in the presence of all group members. 5th and 6th week: holding two practice sessions and repeating and evaluating the learning of the material said in each week for each of the examples. ​
Main outcome variables
Alarm fatigue

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240217061035N1
Registration date: 2024-04-10, 1403/01/22
Registration timing: prospective

Last update: 2024-04-10, 1403/01/22
Update count: 0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
Maryam Barzegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5437 2879
Email address
m.barzegar@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Monitor Alarm Management Training on the level of Alarm Fatigue of Nurses in the Intensive Care Units
Public title
The Effect of Alarms Management Training on Alarm Fatigue in Nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in study Working for at least six months in the intensive care unit Absence of known psychiatric diseases No experience of a stressful event during the past six months Passing the basic course of training to work with devices in the intensive care units
Exclusion criteria:
Hearing impairment that prevents the clear hearing of device alarms Experiencing a stressful event during the 12 weeks of the intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
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
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Yazd-Imam Hossein Square-Imam Reza Complex-Research and Technical Assistant
City
Yazd
Province
Yazd
Postal code
8916877443
Approval date
2024-01-17, 1402/10/27
Ethics committee reference number
IR.SSU.REC.1402.134

Health conditions studied

1

Description of health condition studied
Alarm fatigue in nurses
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Fatigue from alarms
Timepoint
Immediately before the intervention and also one month after the six-week intervention (end of the intervention period)
Method of measurement
Alarm fatigue questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: In this intervention, the educational team includes a trained nurse (researcher) and a medical equipment specialist. In order to carry out draft training of educational materials and learning requirements for monitored devices equipped with alarms (monitoring devices, ventilators, infusion pumps) regarding the management of alarms based on the patient's condition by the research team and based on the available texts along with the initial evaluation And a survey will be prepared from the research environment. If there is a need to provide more specialized materials based on the initial evaluation, an anesthesiologist and an expert in the field of electrocardiogram interpretation (cardiologist or specialist nurse) will be used to provide the planned educational content. In the following, educational classes will be held during six weeks in the form of lectures, workshops and multimedia. The training program (the period of implementation of educational intervention) during six weeks is as follows: First and second week: During the first two weeks, sending at least 10 five-minute clips in the messenger group about how to work with the device with focus Monitor, ventilator, infusion pump, syringe pump and DC shock are set. The three-month internet package will be available to 48 nurses. The clips are compiled and prepared by the educational team in advance based on the educational content. Also, more clips are received and presented to nurses through purchases on reputable nursing sites, including nursing online and medical equipment companies. *During the first two weeks, after sending the clips, notification SMS Notifications and reminders (in the form of SMS) are sent every other day to each person in order to control the contents sent in the group. The third and fourth week: face-to-face training, one session per week and updating the contents of the virtual course. Repetition of the training session for two times for the attendance of all group members. According to the coordination with the desired university and hospitals, during face-to-face training of one and a half to two hours in one session per week, the important and complementary points of working with devices And the setting of alarms is presented with an emphasis on their management based on the patient's condition. Due to the shift in personnel rotation, the meeting will be repeated two more times in the same week by the training team. Reception is provided during face-to-face meetings. A pen, folder with buttons and notepad will be provided to the nurses for taking notes during the face-to-face meeting. 5th and 6th week: Holding two sessions per week related to practice and repetition and learning evaluation of the said material for each of the samples. Questions about medical equipment will be provided to the personnel and they will be given time to answer. Answers to the questions will be discussed in the form of practice and repetition.​
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Special care departments of Seyed al-Shohda hospitals
Full name of responsible person
-Dr. Mohammad Reza Rezaei Mehr
Street address
Motahari Blvd., Khajapur Hospital Complex, Seyed Al Shahada Hospital
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Phone
+98 71 5414 2000
Email
info@jums.ac.ir

2

Recruitment center
Name of recruitment center
Special care department of Peymaniyeh Hospital
Full name of responsible person
Dr. Masoume Pourmokhtari
Street address
Valiasr Street
City
Jahrom
Province
Fars
Postal code
7419886688
Phone
+98 71 5423 0011
Email
paymaniehbimeh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abargoei
Street address
Bahnar Square, Central Organization, Shahid Sadougi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3733 3726
Email
abargouei@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bu Ali St
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 1751 3824
Email
fateme.bakhshii@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Bu Ali St
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
fateme.bakhshii@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Bakhshi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Service Management
Street address
Bu Ali St
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
+98 35 3824 1751
Email
fateme.bakhshii@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All personal data of study participants can be shared after de-identification.
When the data will become available and for how long
After printing the results
To whom data/document is available
The data will be accurate for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Scientific application
From where data/document is obtainable
Fatemeh Bakhshi, Research Center for Nursing and Midwifery Care, Bouali Ave., Safaeyeh, Yazd, Iran. Postal Code: 8916877443; Tel: (+98) 9139684626 Email address: fateme.bakhshii@gmail.com; f.bakhshi@ssu.ac.ir
What processes are involved for a request to access data/document
A week after the applicant's email
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