Protocol summary

Study aim
Determining the effect of performing mindfulness-based intervention on the mental workload of nurses working in Ghaem Hospital in Firoozabad in 2021 Community Verified icon
Design
A randomized, single-blind, randomized controlled clinical trial was performed on 52 nurses working in the emergency and special wards. Random allocation is based on the random allocation software table.
Settings and conduct
for the intervention group, the Mindfulness Program runs for eight 2-hour sessions over two months. The location is Ghaem Firoozabad Hospital.The study is one-sided and the statistical analyzer has no knowledge of the intervention and control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having at least a bachelor's degree in nursing, having at least 6 months of experience in special and emergency departments, not suffering from anxiety and depression as confirmed by your report, and not taking anti-anxiety and anti-psychotic drugs Exclusion criteria will be unwillingness to continue the research, unexcused absence from more than 2 sessions of class, sudden death of relatives, divorce, incurable diseases in individuals or their relatives due to high psychological stress and the possibility of disruption of research results.
Intervention groups
First, both intervention and control groups complete the NASA Mind Load Questionnaire, and then For the intervention group, the mindfulness program is implemented in eight 2-hour sessions over two months.During the sessions, mindfulness techniques such as seeing, hearing, body scanning, breathing and walking are taught in mindfulness. There is no intervention in the control group and in the end, the workload of the mind is compared in the intervention and control groups.
Main outcome variables
mental workload

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210827052298N1
Registration date: 2021-09-16, 1400/06/25
Registration timing: prospective

Last update: 2021-09-16, 1400/06/25
Update count: 0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Maryam Keshavarz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3872 4239
Email address
maryam.keshavarz@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-10-30, 1400/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of performing mindfulness-based intervention on mental workload of nurses
Public title
The effect of performing mindfulness-based intervention on mental workload of nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least a bachelor's degree in nursing Have at least 6 months of experience in special and emergency departments
Exclusion criteria:
Lack of recent suffering from anxiety and depression as confirmed by your report Do not take anti-anxiety and anti-psychotic drugs
Age
From 24 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 52
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling of employed nurses was simple random. The list of employed nurses was taken from the recruitment and nursing office of the hospital and based on the inclusion criteria Each nurse was given a code to announce their readiness. These numbers were randomly selected using Excel software And randomly generated data were selected This code was written on a card and placed inside the box, then the cards were taken out one by one And nurses were divided into intervention and control groups by Using random allocation software. Software address: SAGHAEI,M.2004.Random allocation software for parallel group randomized trials. BMC Medical research methodology,4,26.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is one-sided so that the statistical analyzer does not know the control and intervention groups.
Placebo
Not used
Assignment
Other
Other design features
Participants are divided into two groups of intervention and control. The intervention group receives mindfulness intervention and the control group does not receive until the effect of mindfulness intervention is measured at the end.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Jahrom University of Medical Sciences
Street address
Shahid Motahari Blvd., Medical University St.
City
jahrom
Province
Fars
Postal code
74148-46199
Approval date
2021-08-23, 1400/06/01
Ethics committee reference number
IR.JUMS.REC.1400.032

Health conditions studied

1

Description of health condition studied
mental workload
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
mental workload
Timepoint
The beginning of the study and two months after the intervention
Method of measurement
National aeronautics and space administration (NASA-TLX)

Secondary outcomes

empty

Intervention groups

1

Description
intervention group, the Mindfulness program is implemented in eight 2-hour sessions over two months.mindfulnessIt was first employed at the University of Massachusetts by John Cobb Zayn.Mindfulness is a standardized meditation program that emerged in 1979 from an attempt to integrate Buddhist mindfulness meditation with contemporary psychological and clinical practice.During the sessions, mindfulness techniques such as seeing, hearing, body scanning, breathing and walking are taught in mindfulness.mindfulness is actually an exercise in peace of mind with the presence of the mind, and participants are trained to be aware of their state at all times, and whenever the mind wanders in thoughts or fantasies and memories, regardless of its content, return their attention to the present. Before mindfulness happens to us, we are already conditioned to react to life events and happenings, but after mindfulness happens to us, we become more alert and alert and aware of current events and Life is more complex now, and our responses to stimuli and life events will be wiser and more effective.for example Body scan: When lying down or sitting on a chair, people close their eyes and are asked to focus their attention on the parts of their body, usually starting from one foot and guided to the rest of the body and being taught emotions. Different to look at it with curiosity and think.Homework: For homework, participants are asked to do daily tasks with mindfulness technique and Practice mindfulness techniques at home
Category
Lifestyle

2

Description
Control group: There is no intervention for the control group and it is considered for comparison with the intervention group.at the end of the research, in order to observe ethics, if the mindfulness intervention is effective, we will also perform the intervention for the control group.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Firoozabad Hospital
Full name of responsible person
Maryam Keshavarz
Street address
Pasdaran Boulevard, Ghaem Firoozabad Hospital
City
Firoozabad
Province
Fars
Postal code
74718-41313
Phone
+98 71 3872 7091
Email
maryamkeshavarz262@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Vice President for Research and Technology Dr. Solhjoo
Street address
Ostad Motahhari St. - after the School of Nursing - Jahrom University of Medical Sciences - Pardis website
City
jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 0409
Email
Centlib@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side after Imam Hussein Mosque,Alley 13,Pasdaran Blvd
City
Firoozabad
Province
Fars
Postal code
74719-53341
Phone
+98 71 3872 4239
Fax
Email
maryam.keshavarz@jums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Ali Dehghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ostad Motahhari St., Jahrom University of Medical Sciences
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5434 0409
Email
ali.dehghani2000@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Maryam Keshavarz
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Side after Imam Hussein Mosque,Alley 13,Pasdaran Blvd
City
Firoozabad
Province
Fars
Postal code
74719-53341
Phone
+98 71 3872 4239
Fax
Email
maryam.keshavarz@jums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
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
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