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Effect of educational intervention on the prevention of Musculoskeletal Pain (MSP) in elementary school students

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History
# Registration date Revision Id
2 2018-05-09, 1397/02/19 49099
1 2018-02-01, 1396/11/12 35523
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  • Protocol summary

    Design, implementation and evaluation of an interventional program for preventing Musculoskeletal Pain (MSP)among primary school students
    Design, implementation and evaluation of an interventional program for preventing Musculoskeletal Pain (MSP) among primary school students
    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
    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
    Musculoskeletal Pain؛ posture؛ bag weight؛ knowledge؛ perceived sensitivity؛ perceived severity؛ perceived benefits؛ perceived barriers؛ Cues to action and self-efficacy
    Musculoskeletal Pain؛ posture؛ bag weight؛ knowledge؛ perceived sensitivity؛ perceived severity؛ perceived benefits؛ perceived barriers؛ Reinforcing Factors؛ Enabling Factors and self-efficacy
    دردهای اسکلتی عضلانی، پوسچر، وزن کیف، آگاهی، حساسیت درک شده، شدت درک شده، منافع درک شده، موانع درک شده، راهنما به عمل و خودکارآمدی
    دردهای اسکلتی عضلانی، پوسچر، وزن کیف، آگاهی، حساسیت درک شده، شدت درک شده، منافع درک شده، موانع درک شده، عوامل تقویت کننده، عوامل قادر کننده و خودکارآمدی

  • General information

    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
    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
    از روش نمونه گیری خوشه ای چند مرحله استفاده خواهد شد. طبقات نمونه مورد مطالعه با توجه نواحی براساس سطوح اقتصادی اجتماعی ( بالا، متوسط و پایین شهر)، جنسیت (دختر و پسر) و پایه تحصیلی دانش آموزان انتخاب خواهند شد. سپس فهرست مدارس و تعداد دانش آموزان ابتدایی شهر همدان از اداره آموزش و پرورش کل گرفته شد. براساس حجم نمونه مورد نیاز، به روش تصادفی ساده از بین مدارس ابتدایی هر ناحیه با توجه به جدول اعداد تصادفی 3 مدرسه دخترانه و 3 مدرسه پسرانه انتخاب خواهد شد. سپس از هر مدرسه تمام پایه ها ( پایه اول تا ششم ابتدایی) و از هر کلاس 10 دانش آموز براساس لیست دانش آموزان بطور تصادفی انتخاب خواهد شد.
    از روش نمونه گیری خوشه ای چند مرحله استفاده خواهد شد. طبقات نمونه مورد مطالعه با توجه نواحی براساس سطوح اقتصادی اجتماعی ( بالا، متوسط و پایین شهر)، جنسیت (دختر و پسر) و پایه تحصیلی دانش آموزان انتخاب خواهند شد. سپس فهرست مدارس و تعداد دانش آموزان ابتدایی شهر همدان از اداره آموزش و پرورش کل گرفته شد. براساس حجم نمونه مورد نیاز و با توجه به تعداد مدارس موجود در هر ناحیه، به روش تصادفی ساده و با توجه به جدول اعداد تصادفی 6 مدرسه از ناحیه یک (3 مدرسه دخترانه و 3 مدرسه پسرانه ) و 7 مدرسه از ناحیه دو (4 مدرسه دخترانه و 3 مدرسه پسرانه) انتخاب خواهد شد. سپس از هر مدرسه تمام پایه ها ( پایه اول تا ششم) و از هر پایه یک کلاس به طور تصادفی انتخاب خواهند شد و از هر کلاس نمونه مورد نیاز متناسب با تعداد دانش آموزان موجود در هر پایه براساس لیست دانش آموزان بطور تصادفی انتخاب خواهند شد.

  • Health conditions studied

    #1
    empty
    M95-M99
    empty
    Other disorders of the musculoskeletal system and connective tissue

  • Secondary outcomes

    #1
    Cues to action
    Reinforcing Factors
    راهنما به عمل
    عوامل تقویت کننده
    #2
    empty
    Enabling Factors
    empty
    عوامل قادر کننده
    empty
    Before intervention, and 6 months after intervention
    empty
    قبل از شروع مداخله، و 6 ماه بعد از مداخله
    empty
    Researcher made questionnaire
    empty
    پرسشنامه محقق ساخته

  • Recruitment centers

    #1
    Name of recruitment center - English: Primary schools in Hamadan
    Name of recruitment center - Persian: مدارس ابتدایی شهر همدان
    Full name of responsible person - English: الهام قیسوندی
    Full name of responsible person - Persian: elhamghysvandi
    Street address - English: Shahid Fahmideh St, Hamadan University of Medical Sciences
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:
    Name of recruitment center - English: Elementary schools in Hamadan
    Name of recruitment center - Persian: مدارس ابتدایی شهر همدان
    Full name of responsible person - English: Elham Gheysvandi
    Full name of responsible person - Persian: الهام قیسوندی
    Street address - English: Shahid Fahmideh St, Hamadan University of Medical Sciences
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: saied bashirian
    Full name of responsible person - Persian: سعید بشیریان
    Street address - English: Shahid Fahmideh st, Hamadan University of Medical Sciences
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0717
    Fax:
    Email: s_bashirian@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Saied Bashirian
    Full name of responsible person - Persian: سعید بشیریان
    Street address - English: Shahid Fahmideh st, Hamadan University of Medical Sciences
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0717
    Fax:
    Email: s_bashirian@yahoo.com
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elham Gheysvandi
    Full name of responsible person - Persian: الهام قیسوندی
    Position - English: Ph.D Student, Health Education and Health Promotion
    Position - Persian: دانشجوی دکتری آموزش بهداشت و ارتقای سلامت
    Latest degree: master
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Fahmideh st, Hamedan University of Medical Sciences
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Mobile: +98 918 870 2445
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elham Gheysvandi
    Full name of responsible person - Persian: الهام قیسوندی
    Position - English: Ph.D Student, Health Education and Health Promotion
    Position - Persian: دانشجوی دکتری آموزش بهداشت و ارتقای سلامت
    Latest degree: master
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hamadan University of Medical Sciences, Shahid Fahmided st
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Mobile: +98 918 870 2445
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elham Gheysvandi
    Full name of responsible person - Persian: الهام قیسوندی
    Position - English: Ph.D Student, Health Education and Health Promotion
    Position - Persian: دانشجوی دکتری آموزش بهداشت و ارتقای سلامت
    Latest degree: master
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Fahmide st, Hamadan University of Medical Sciences
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Mobile: +98 918 870 2445
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elham Gheysvandi
    Full name of responsible person - Persian: الهام قیسوندی
    Position - English: Ph.D Student, Health Education and Health Promotion
    Position - Persian: دانشجوی دکتری آموزش بهداشت و ارتقای سلامت
    Latest degree: master
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hamadan University of Medical Sciences, Shahid Fahmide st
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Mobile: +98 918 870 2445
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elham Gheysvandi
    Full name of responsible person - Persian: الهام قیسوندی
    Position - English: PhD student in health education and health promotion
    Position - Persian: دانشجو دکتری اموزش بهداشت و ارتقای سلامت
    Latest degree: master
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Fahmideh st, Hamadan University of Medical Sciences
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Mobile: +98 918 870 2445
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Elham Gheysvandi
    Full name of responsible person - Persian: الهام قیسوندی
    Position - English: PhD student in health education and health promotion
    Position - Persian: دانشجو دکتری اموزش بهداشت و ارتقای سلامت
    Latest degree: master
    Area of specialty/work: 14
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hamadan University of Medical Sciences, Shahid Fahmideh st
    Street address - Persian: خیابان شهید فهمیده، دانشگاه علوم پزشکی همدان
    City - English: Hamadan
    City - Persian: همدان
    Province: Hamadan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6517838736
    Phone: +98 81 3838 0360
    Mobile: +98 918 870 2445
    Fax:
    Email: elhamgheysvandi65@yahoo.com
    Web page address:

Protocol summary

Study aim
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, and 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؛ Reinforcing Factors؛ Enabling Factors 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: 2018-06-13, 1397/03/23
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. 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
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
M95-M99
ICD-10 code description
Other disorders of the musculoskeletal system and connective tissue

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
Reinforcing Factors
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

10

Description
Enabling Factors
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
Elementary schools in Hamadan
Full name of responsible person
Elham Gheysvandi
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
Hamadan University of Medical Sciences, Shahid Fahmided st
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
Hamadan University of Medical Sciences, Shahid Fahmide st
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
Hamadan University of Medical Sciences, Shahid Fahmideh st
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
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