Protocol summary

Study aim
Determining the effect of acobsen relaxation application on anxiety and job stress of nurses caring for Covid 19 patients
Design
A community-based, pragmatic, control group clinical trial was randomized with parallel groups.
Settings and conduct
Jacobsen relaxation technique will be performed by nurses for 30 minutes daily for one month. This technique will be performed by nurses in a private room in Shahid Beheshti Hospital in Kashan.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Age between 25 and 60 years; Work experience of more than one year; Nurse caring for patients with Covid 19; Having a smart phone with Android operating system No entry conditions: Simultaneous use of other complementary therapies; Create severe anxiety at the discretion of the psychiatrist; No use or irregularity in the use of the content of the Jacobsen relaxation application
Intervention groups
At the beginning of the research, Jacobsen relaxation application will be designed by the research researchers. Then the application will be installed on the intervention group mobile. In intervention group, Jacobsen relaxation will be performed by nurses for 30 minutes daily for one month. Jacobsen relaxation technique is displayed in the application and the nurse will perform it. In the control group, nurses will not receive any intervention during the study.
Main outcome variables
Anxiety ; Job stress

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20111210008348N51
Registration date: 2021-04-10, 1400/01/21
Registration timing: prospective

Last update: 2021-04-10, 1400/01/21
Update count: 0
Registration date
2021-04-10, 1400/01/21
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-06, 1400/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Jacobsen relaxation application on anxiety and job stress of nurses caring for Covid 19 patients
Public title
The effect of Jacobsen relaxation application on anxiety and job stress of nurses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 and 60 years Work experience of more than one year Nurse caring for patients with Covid 19 Having a smart phone with Android operating system
Exclusion criteria:
Simultaneous use of other complementary therapies Create severe anxiety at the discretion of the psychiatrist No use or irregularity in the use of the content of the Jacobsen relaxation application
Age
From 25 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in the two groups of intervention and control uses the method of random blocks (7 blocks of 10 people) using software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2021-03-07, 1399/12/17
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1399.088

Health conditions studied

1

Description of health condition studied
Jacobsen Relaxation
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures

Primary outcomes

1

Description
Anxiety
Timepoint
Before, immediately after the end of the study and one month later
Method of measurement
Spielberger Anxiety Inventory

2

Description
Job stress
Timepoint
Before, immediately after the end of the study and one month later
Method of measurement
Osipow jab stress inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Jacobsen relaxation technique will be performed by nurses every day for 30 minutes for a month. Jacobsen relaxation technique includes Being comfortable and then contracting and expanding different muscle groups is accompanied by deep breathing.
Category
Prevention

2

Description
Control group: No intervention will be done to reduce anxiety and job stress of control group nurses.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Kashan
Full name of responsible person
Shahla Yosofzad
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
yosofzad.shahla@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Vice Chancellor of Research & Technology, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
banafshe_h@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
mirbagher_n@kaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Masoumeh Hosseinian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
hoseinian_1342@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Shahla Yosofzad
Position
Master's degree student in nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
yosofzad.shahla@gmail.com

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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