Protocol summary

Study aim
Design and evaluation of an educational intervention based on the Health Belief Model in adopting neck pain prevention behaviors in teachers.
Design
Clinical trial with intervention and control groups, with parallel, Three-way blind, randomized groups, which will be performed on 140 people. A sealed envelope will be used for randomization.
Settings and conduct
The study is based on 140 primary school teachers in the 19th district of Tehran. Participants will be divided into two groups of control and intervention by simple randomization. Training and virtual ergonomic interventions will be performed on the intervention group, but no intervention will be performed on the control group. At the same time, pre-test questionnaires will be provided to both groups (control and intervention) for initial needs assessments. After collecting information, the data will be parsed and analyzed. Then we will design the training program and training intervention virtually.
Participants/Inclusion and exclusion criteria
Entry requirements: 1.Teachers who have access to the Internet and mobile phones. No entry conditions: 1.People's unwillingness to continue participating in research. 2.Teachers who have a second job. 3.Teachers with congenital musculoskeletal disorders of the neck. 4.Teachers who forbid the doctor to do sports.
Intervention groups
The intervention group will receive training but the control group will not receive training and in the end the effect of the intervention will be compared in both groups.
Main outcome variables
Awareness; behavior; perceived sensitivity; severely perceived; perceived barriers; perceived benefits; efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210301050542N1
Registration date: 2021-03-16, 1399/12/26
Registration timing: prospective

Last update: 2021-03-16, 1399/12/26
Update count: 0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Zohre Moradi
Name of organization / entity
The university of tarbiat modares
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 2184
Email address
zohremoradi@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designning and Evaluating Educational Intervention Based on Health Belief Model in Neck Pain Prevention Behaviors in Teachers.
Public title
Evaluation of the Effect of Educational Intervention on Neck Pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Teachers who have access to the internet, mobile phones and the skills to use them.
Exclusion criteria:
People's unwillingness to continue participating in research. Teachers who have a second job. People with congenital musculoskeletal disorders of the neck. People with a history of surgery, neck fractures and significant neck pain. People who have a doctor forbidding them to do sports.
Age
From 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
First, the names of all schools will be specified with a code and the relevant codes will be poured into a bag, or the computer will be randomly divided into two groups (test and control) using the computer method. After dividing the schools into two groups of control and test, the names of all teachers are re-identified and a bag is poured into the bag and people will be randomly selected from the bag and divided into two groups. Each group of 70 people will be selected for the study. 70 people will be selected as the control group and 70 people as the experimental group. To prevent any predictions by the participants and the researcher, the random allocation concealment method will be used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this research, the researcher, the participants in the research and the people analyzing the data do not know the names of the people. The participants in the research will be identified based on the code and no personal information will be collected from the people in the research.
Placebo
Not used
Assignment
Parallel
Other design features
Design of educational intervention based on health belief model.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2021-01-13, 1399/10/24
Ethics committee reference number
IR.MODARES.REC.1399.163

Health conditions studied

1

Description of health condition studied
Neck Pain
ICD-10 code
M54.02
ICD-10 code description
Panniculitis affecting regions of neck and back, cervical region

Primary outcomes

1

Description
Awareness
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

2

Description
Perceived sensitivity
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

3

Description
Severely perceived
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

4

Description
Perceived benefits
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

5

Description
Perceived obstacles
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

6

Description
Cues to Action
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

7

Description
Efficacy
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

8

Description
Behavior
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

Secondary outcomes

1

Description
Neck pain prevention behavior score
Timepoint
Before the intervention and immediately after the intervention, three months after the intervention
Method of measurement
Researcher-made questionnaire

Intervention groups

1

Description
"Intervention group:" This group is trained for one month in a virtual way by holding webinars, presenting educational clips, pamphlets and posters, after which they will be under reminder trainings for 2 months.
Category
N/A

2

Description
"Control group:" There are 70 junior high school teachers who will not receive any intervention during the research period. Before the intervention, immediately after the intervention, and three months after the intervention, they will fill in the researcher-made questionnaire and the results It will be compared with the results of the intervention group and statistical analysis.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Schools in District 19 of Tehran
Full name of responsible person
Zohre Moradi
Street address
Narges Dormitory 3 , Tarbiat Modares University, Nasr Bridge, Jala Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4547
Email
zohremoradi@modares.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Trabiat Modares University
Full name of responsible person
Yaqub Fath Elahi
Street address
Tarbiat Modares University, Nasr Bridge, Jala Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4547
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
Trabiat 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
Sedigheh Sadat Tavafian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jala Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4547
Email
tavafian@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jala Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4547
Email
tavafian@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sedigheh Sadat Tavafian
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jala Al-Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4547
Email
tavafian@modares.ac.ir

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
Yes - There is 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
Part of the data related to the main consequences can be shared.
When the data will become available and for how long
Six months after the results were published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Repeated measurement analysis to evaluate the effect of training duration six months after the last intervention.
From where data/document is obtainable
By sending an email to the email address zohremoradi@modares.ac.ir
What processes are involved for a request to access data/document
One week after sending the email, the applicant will respond to the email address zohremoradi@modares.ac.ir.
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