Protocol summary

Study aim
Determining the effect of multifaceted interventions on the improvement of musculoskeletal disorders of nurses working in the intensive care unit
Design
A clinical trial with a control group with a sample size of 72 people, of which 36 people are assigned to each group, using a simple random method. No blinding
Settings and conduct
In the special care department of Golestan and Imam Khomeini Hospital, Ahvaz, in the first three weeks, a 30-minute lecture session, and from week 3 to 6, weekly meetings to fix bugs and improve the environment
Participants/Inclusion and exclusion criteria
Inclusion criteria: nurses who directly care for patients and have musculoskeletal disorders caused by work Exclusion criteria: unwillingness to continue cooperation and pregnancy
Intervention groups
Interventions in the form of feedback lecture sessions in the field of musculoskeletal disorders related to work, symptoms, epidemiology, risk factors and their consequences, health behavior education regarding the concept of ergonomics, the effect of ergonomic principles in preventing and reducing musculoskeletal disorders caused by Nursing work, training in the field of correct sitting position, seat height adjustment, physical exercises, walking, turning and workplace safety, safety barriers, teamwork and communication, improving the environment of the special care department through the use of cushions and front legs and positioning. It will be appropriate to distribute brochures and send messages to the mobile phones of the participants and hold troubleshooting meetings, no action will be taken in the control group.
Main outcome variables
Improvement of musculoskeletal disorders in intensive care nurses

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231030059907N1
Registration date: 2023-11-20, 1402/08/29
Registration timing: prospective

Last update: 2023-11-20, 1402/08/29
Update count: 0
Registration date
2023-11-20, 1402/08/29
Registrant information
Name
Mahdiye Marzban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3320 0105
Email address
mahdiyemarzban@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-06, 1402/09/15
Expected recruitment end date
2024-03-04, 1402/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Multidimensional Interventions on the Improvement of Musculoskeletal Disorders of Nurses Working in Intensive Care Units
Public title
The Effect of Multidimensional Interventions on the Improvement of Musculoskeletal Disorders of Nurses Working in Intensive Care Units
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year of Experience in Intensive Care Unit Having at least a Bachelor's Degree in Nursing Absence of Congenital Skeletal Disorders No History of Surgery on the Spine Absence of Pregnancy Confirmation of Musculoskeletal Disorder Based on the Nordic questionnaire
Exclusion criteria:
Nurses with less than a Bachelor's Degree Nurses who are not Directly Involved in Patient Care Nurses who Use Painkillers Unwillingness to Participate in the Study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, based on the results of previous studies and according to the opinion of the respected consultant of statistics and methodology, the number of samples will be 72 people. In a simple random way, one of Golestan and Imam Khomeini hospitals in Ahvaz will be assigned to the intervention group and the other to the control group. From each hospital, 2 ICU departments are randomly determined and the samples are selected based on the entry criteria. According to the calculations and the possible drop of 20%, the sample size in each group will be 36 people.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur Ahvaz University of Medical Sciences
Street address
Jundishapur Ahvaz University of Medical Sciences, Esfand St, University City, Golestan Boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357 -15794
Approval date
2023-10-23, 1402/08/01
Ethics committee reference number
IR.AJUMS.REC.1402.380

Health conditions studied

1

Description of health condition studied
Musculoskeletal Disorders
ICD-10 code
M95.8
ICD-10 code description
Other specified acquired deformities of musculoskeletal system

Primary outcomes

1

Description
Work-related musculoskeletal disorders
Timepoint
At the beginning of the study and at the end of the sixth and twelfth weeks after the intervention
Method of measurement
Nordic Musculoskeletal Questionnaire

Secondary outcomes

1

Description
Perception of Risk
Timepoint
At the beginning of the study and at the end of the sixth and twelfth weeks after the intervention
Method of measurement
Risk perception of musculoskeletal injury

2

Description
Physical Behavior
Timepoint
At the beginning of the study and at the end of the sixth and twelfth weeks after the intervention
Method of measurement
Questionnaire for assessing the status of nursing physical behaviors

3

Description
Workplace safety
Timepoint
At the beginning of the study and at the end of the sixth and twelfth weeks after the intervention
Method of measurement
Nurses' safety Climate Questionnaire

Intervention groups

1

Description
Intervention group: The intervention group is trained as follows:In general, the interventions will be carried out during 6 weeks, the first, second and third weeks are dedicated to weekly feedback sessions.1- The first session: a 30-minute feedback lecture in the first week in the field of work-related musculoskeletal disorders, symptoms, epidemiology, risk factors and consequences, which will be conducted by the researcher.2- The second session: a 30-minute feedback lecture in the second week in the field of health behavior education regarding the concept of ergonomics, the effect of ergonomic principles in preventing and reducing musculoskeletal disorders caused by nursing work, training in the field of correct sitting position, Adjusting the height of the chair, physical exercises, walking, turning, how to move patients and lift equipment will be done by an ergonomic specialist.3- The third session: In the field of safe work environment, a 30-minute feedback lecture will be given in the third week about the safety of the work environment, safety barriers, teamwork and communication by an ergonomic expert and a researcher.From the 4th to the 6th week, the following steps will be taken:1- Distributing brochures and sending messages through mobile phones regarding work-related musculoskeletal disorders, factors affecting these disorders, protective exercises and ergonomic principles to prevent these disorders from occurring or worsening on a weekly basis.2- Holding weekly meetings in the form of practical exercises to strengthen the health behaviors taught, including correct sitting position, walking, turning, moving patients correctly, adjusting the height of the chair and fixing problems.3- Improving the ICU environment by making changes such as replacing height-adjustable chairs instead of fixed-height chairs, 2 front legs and 2 back legs for chairs (cushions), using stools to access the equipment in are high and the correct placement of devices in the environment, taking into account the access limit and how to use them, as well as the purpose of using these devices, will be explained to the nurses in the form of a lecture.All the trainings will be done under the supervision of an ergonomics expert, and in order to comply with ethical issues, after studying the training material, it will be given to the control group in the form of pamphlets and brochures.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Dr. Simin Jahani
Street address
Golestan Educational and Medical Center, Farvardin St, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 61 3320 4501
Fax
+98 61 3337 4058
Email
golestanjpspital@yahoo.com
Web page address
https://hgolestan.ajums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Simin Jahani
Street address
Imam Khomeini Hospital, Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2114
Fax
Email
himam@ajums.ac.ir
Web page address
http://himam.ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mehrnoosh Zakerkish
Street address
Esfand St, University City, Golestan Boulevard, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3311 0000
Fax
+98 21 8882 4675
Email
mahdiyemarzban@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Simin Jahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
613571579
Phone
+98 61 3373 8333
Fax
+98 61 3336 1544
Email
Jahanisimin50@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Simin Jahani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Jundishapur University of Medical Sciences, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3373 8333
Fax
+98 61 3336 1544
Email
Jahanisimin50@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahdiye Marzban
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Unit 5, No. 226, Ordibehesht Street, Golestan, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6136834771
Phone
+98 61 3320 0105
Email
mahdiyemarzban@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
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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