Protocol summary
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Study aim
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Design, implementation and evaluation of an interventional program for preventing Musculoskeletal Pain (MSP) among primary school students
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Design
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The design of the study is in two stages: descriptive-analytical and interventional. The sample size in the first stage is 670 students and their parents, and in the second stage 222 students with high prevalence of musculoskeletal pain eligible to enter the study.
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Settings and conduct
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Interventions will be taken to prevent and reduce Musculoskeletal pain(MSP) in Hamadan and in the school environment. Participants are randomly divided into two groups of intervention and control, and Interventions will be provided in the intervention group
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Participants/Inclusion and exclusion criteria
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Inclusion criteria Elementary students (1st to 6th grades), completion of informed consent by parents, Students' tend to participate in the stud; exclusion criteria:Students who have birth defects,
Students who are affected by reason of secondary cause such as accidents and else.
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Intervention groups
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Intervention group: 111 primary school students who will use educational intervention.
Control group: 111 primary school students without interventional intervention
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Main outcome variables
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Musculoskeletal Pain؛ posture؛ bag weight؛ knowledge؛ perceived sensitivity؛ perceived severity؛ perceived benefits؛ perceived barriers؛ Reinforcing
Factors؛ Enabling Factors and self-efficacy
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171218037935N1
Registration date:
2018-02-01, 1396/11/12
Registration timing:
prospective
Last update:
2018-06-13, 1397/03/23
Update count:
1
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Registration date
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2018-02-01, 1396/11/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-04, 1396/11/15
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Expected recruitment end date
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2019-04-21, 1398/02/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of educational intervention on the prevention of Musculoskeletal Pain (MSP) in elementary school students
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Public title
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Design, implementation and evaluation of an interventional program for preventing Musculoskeletal Pain (MSP) mong primary school students
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Elementary School Students (First to Sixth Grades)
Complete informed consent by parents
Students tend to participate in the study
Exclusion criteria:
Students who have birth defects.
Students who are affected by reason of secondary cause such as accidents and else.
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Age
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From 7 years old to 13 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
222
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Multi-stage cluster sampling will be used. The sample classes are selected based on the socioeconomic levels (high, middle and low), gender (girls and boys), and the students' educational base. Then the list of schools and the number of elementary students in the city of Hamedan was taken from the Department of Education. According to the required sample size and according to the number of schools in each district, randomly, according to the random number table, six schools in district one (three girls' schools and three male schools) and seven schools in district two (four schools Girls and 3 male boys) will be selected. Then from each school, all the grades (from the first to sixth) and from each grade of a class will be randomly selected, and from each class the required sample will be selected randomly according to the number of students in each grade on the list of students
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-16, 1396/09/25
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Ethics committee reference number
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IR.UMSHA.REC.1396.641
Health conditions studied
1
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Description of health condition studied
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Musculoskeletal pain
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ICD-10 code
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M95-M99
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ICD-10 code description
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Other disorders of the musculoskeletal system and connective tissue
Primary outcomes
1
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Description
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Musculoskeletal pain
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Timepoint
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3 and 6 months after the intervention
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Method of measurement
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questionnaire
Secondary outcomes
1
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Description
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Posture
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Timepoint
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Before intervention, 3 and 6 months after the intervention
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Method of measurement
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Observation based on the standard checklist RULA
2
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Description
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Bag weight
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Timepoint
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Before intervention, 3 and 6 months after the intervention
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Method of measurement
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Measuring the weight of the bag with a scales
3
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Description
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knowledge
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
4
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Description
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Perceived Susceptibility
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
5
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Description
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Perceived Severity
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
6
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Description
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Perceived Benefits
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
7
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Description
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Perceived Barriers
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
8
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Description
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Reinforcing Factors
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
9
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Description
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Self-efficacy
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
10
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Description
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Enabling Factors
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Timepoint
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Before intervention, and 6 months after intervention
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Method of measurement
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Researcher made questionnaire
Intervention groups
1
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Description
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Intervention group: 3 Educational sessions;educational booklet;educational film;pamphlet and stretching
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Category
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Behavior
2
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Description
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Control group:This group does not receive any intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Hamedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available