Development and evaluation of a theory based interactive social media intervention to reduce occupational low back pain in nursing profession
Design
Three hundred nurses working in hospitals affiliated to Mazandaran University of Medical Sciences who are eligible to enter into the study will be selected. For a sample, a list of hospitals will be provided. Then three hospitals will be selected and randomly assigned to each study group. The sample size of 100 nurses is estimated for each study group.
In each hospital, proportion to the number of nurses working in each department, individuals will be randomly selected. Each participants will be assigned a code
a code.
Settings and conduct
This experimental study will be carried out in teaching hospitals in Mazandaran University of Medical Sciences and a sample of nurses will be entered into the study and assign to either intervention groups (2 groups) or the control group. Nurses in the intervention groups will receive a social media training or in-person education while nurses in the control group will receive nothing. After completion of the study nurses in the control group will receive one of the interventions based on their interest.
Participants/Inclusion and exclusion criteria
Inclusion criteria
a) Nurses working in hospitals, b) Access to Internet, c) Having skills to work with Internet and mobile
Exclusion criteria
a) Having any illness or problems that prevent a person from participating in the study and exercise for any reasons, b) Being pregnant, c) Having a pathological low back pain, d) Taking medication for low back pain
Intervention groups
The two intervention groups will receive the intervention via social media and in-person education, receptively while the control group will receive nothing.
Main outcome variables
Low back pain reduction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170313033054N2
Registration date:2018-02-25, 1396/12/06
Registration timing:prospective
Last update:2018-02-25, 1396/12/06
Update count:0
Registration date
2018-02-25, 1396/12/06
Registrant information
Name
Seyedeh Somayeh Kazemi
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21
Email address
somayehkazemi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University, Tehran, Iran
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-05-19, 1397/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effectiveness of interactive social media and in-person educational interventions to reduce occupational low back pain in nursing profession
Public title
Interactive social media intervention to reduce low back pain in nurses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses working in hospitals
Access to Internet
Having skills to work with Internet and mobile
Exclusion criteria:
Having any illness or problems that prevent a person from participating in the study and exercise for any reasons
Being pregnant
Having a pathological low back pain
Taking medication for low back pain
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
For sampling, first we provide a list of all hospitals affiliated to Mazandaran University of Medical Sciences and 3 hospitals will be selected. Then, selected hospitals will be randomly allocated to either intervention or control groups based on 1, 2, and 3 blocking (2 hospitals as intervention groups and 1 hospital control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Participants will not be informed about group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
No. 7, Nasr Bridge, Jalal Al Ahmad Street, Tarbiat Modares University, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.TMU.REC.1395.545
Health conditions studied
1
Description of health condition studied
Not applicable
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Low back pain
Timepoint
Before intervention, 6 months after intervention, 12 months
Method of measurement
Visual Analogue Scale of low back pain; VAS hours
Secondary outcomes
1
Description
Disability due to low back pain
Timepoint
Before intervention, 6 months after intervention, 12 months after intervention
Intervention group 1: This group will receive the intervention via a mobile application through an interactive social media . They will receive training how to use the application and they will be monitored by the main investigator. They will receive a weekly reminder during the study period. The content of intervention will be based on PRECEDE model containing issues related to prevention of occupational low back pain.
Category
Behavior
2
Description
Intervention group 2: This group will receive the intervention via in-person education. The educational program will be designed for two sessions (each in one hour) and they will receive a weekly reminding message during the study period. The content of intervention will be similar to group one.
Category
Behavior
3
Description
Control group: This group will receive nothing. However, after completion of the study nurses in the control group will receive one of the interventions based on their interest.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Haideh Hezarjaribi
Street address
Amir Mazandaran Street, Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 1701
Email
somayehkazemi@modares.ac.ir
2
Recruitment center
Name of recruitment center
Bu-Ali Sina Hospital
Full name of responsible person
Batoul Alaei
Street address
Pasdaran Blvd, Bu-Ali Sina Hospital
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3010
Email
somayehkazemi@modares.ac.ir
3
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Najibeh Rastegarnia
Street address
Artesh Blvd, Mazandaran Heart Center, Fatemeh Zahra Hospital
City
Sari
Province
Mazandaran
Postal code
4818813371
Phone
+98 11 3332 9700
Fax
Email
somayehkazemi@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr.Yaghoub Fathollahi Nanekaran. Research Assistant at Tarbiat Modares University
Street address
No. 7, Nasr Bridge, Jalal Al Ahmad Street, Tarbiat Modares University, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
fatolahi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Seyedeh Somayeh Kazemi
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
No. 7, Nasr Bridge, Jalal Al Ahmad Street, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4547
Fax
Email
somayehkazemi@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedighe Sadat Tavafian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
No. 7, Nasr Bridge, Jalal Al Ahmad Street, Tehran
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4547
Fax
Email
tavafian@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seyedeh Somayeh Kazemi
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
NO. 7, Nasr Bridge, Jalal Al Ahmad Street, Tehran -
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 4547
Fax
Email
somayehkazemi@modares.ac.ir
Web page address
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
I have not decided yet.
When the data will become available and for how long
I have not decided yet.
To whom data/document is available
I have not decided yet.
Under which criteria data/document could be used
I have not decided yet.
From where data/document is obtainable
I have not decided yet.
What processes are involved for a request to access data/document