Design, implementation and evaluation of an interventional program for preventing Musculoskeletal Pain (MSP)among primary school students
Design
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.
Settings and conduct
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. Interventions will be provided in the intervention group
Participants/Inclusion and exclusion criteria
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.
Intervention groups
Intervention group: 111 primary school students who will use educational intervention.
Control group: 111 primary school students without interventional intervention
Main outcome variables
Musculoskeletal Pain؛ posture؛ bag weight؛ knowledge؛ perceived sensitivity؛ perceived severity؛ perceived benefits؛ perceived barriers؛ Cues to action and self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171218037935N1
Registration date:2018-02-01, 1396/11/12
Registration timing:prospective
Last update:2018-02-01, 1396/11/12
Update count:1
Registration date
2018-02-01, 1396/11/12
Registrant information
Name
elham gheysvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0360
Email address
e.ghiasvand@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of educational intervention on the prevention of Musculoskeletal Pain (MSP) in elementary school students
Public title
Design, implementation and evaluation of an interventional program for preventing Musculoskeletal Pain (MSP) mong primary school students
Purpose
Prevention
Inclusion/Exclusion criteria
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.
Age
From 7 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
222
Randomization (investigator's opinion)
Randomized
Randomization description
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. Based on the required sample size, randomly, the primary schools of each district will be selected according to random numbers table of 3 girls 'schools and 3 boys' schools. Then, from each school, all the bases (first to sixth grade), and from each class, 10 students will be randomly selected according to the student list
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 Hamadan University of Medical Sciences
Street address
Shahid Fahmided st, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2017-12-16, 1396/09/25
Ethics committee reference number
IR.UMSHA.REC.1396.641
Health conditions studied
1
Description of health condition studied
Musculoskeletal pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Musculoskeletal pain
Timepoint
3 and 6 months after the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Posture
Timepoint
Before intervention, 3 and 6 months after the intervention
Method of measurement
Observation based on the standard checklist RULA
2
Description
Bag weight
Timepoint
Before intervention, 3 and 6 months after the intervention
Method of measurement
Measuring the weight of the bag with a scales
3
Description
knowledge
Timepoint
Before intervention, and 6 months after intervention
Method of measurement
Researcher made questionnaire
4
Description
Perceived Susceptibility
Timepoint
Before intervention, and 6 months after intervention
Method of measurement
Researcher made questionnaire
5
Description
Perceived Severity
Timepoint
Before intervention, and 6 months after intervention
Method of measurement
Researcher made questionnaire
6
Description
Perceived Benefits
Timepoint
Before intervention, and 6 months after intervention
Method of measurement
Researcher made questionnaire
7
Description
Perceived Barriers
Timepoint
Before intervention, and 6 months after intervention
Method of measurement
Researcher made questionnaire
8
Description
Cues to action
Timepoint
Before intervention, and 6 months after intervention
Method of measurement
Researcher made questionnaire
9
Description
Self-efficacy
Timepoint
Before intervention, and 6 months after intervention
Method of measurement
Researcher made questionnaire
Intervention groups
1
Description
Intervention group: 3 Educational sessions;educational booklet;educational film;pamphlet and stretching
Category
Behavior
2
Description
Control group:This group does not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Primary schools in Hamadan
Full name of responsible person
الهام قیسوندی
Street address
Shahid Fahmideh St, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0360
Email
elhamgheysvandi65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
saied bashirian
Street address
Shahid Fahmideh st, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Elham Gheysvandi
Position
Ph.D Student, Health Education and Health Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shahid Fahmideh st, Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0360
Email
elhamgheysvandi65@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elham Gheysvandi
Position
Ph.D Student, Health Education and Health Promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shahid Fahmide st, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0360
Email
elhamgheysvandi65@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Elham Gheysvandi
Position
PhD student in health education and health promotion
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Shahid Fahmideh st, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0360
Email
elhamgheysvandi65@yahoo.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