Evaluating the effect of a theory-based educational program on healthy spine-related behavior among female fifth grade elementary school - Randomized Community Trial
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General information
Effect of educational program on healthy spine-related behavior
Effectiveness of a theory-based educational program on healthy spine-related behavior
EffectEffectiveness of a theory-based educational program on healthy spine-related behavior
تأثیر برنامه آموزشی بر رفتار سلامت محور ستون فقرات
تأثیر برنامه آموزشی مبتنی بر تئوری بر رفتار سلامت محور ستون فقرات
تأثیر برنامه آموزشی مبتنی بر تئوری بر رفتار سلامت محور ستون فقرات
Evaluating the effect of educational program based on theory on healthy spine-related behavior among female fifth grade elementary school - Randomized Community Trial
Evaluating the effect of a theory-based educational program on healthy spine-related behavior among female fifth grade elementary school - Randomized Community Trial
Evaluating the effect of a theory-based educational program based on theory on healthy spine-related behavior among female fifth grade elementary school - Randomized Community Trial
ارزیابی تأثیر برنامه ی آموزشی مبتنی بر تئوری بر رفتارسلامت محور مرتبط با ستون فقرات در دختران پایه ی پنجم ابتدایی -کارآزمایی میدانی تصادفی کنترل شده
ارزیابی تأثیر برنامه آموزشی مبتنی بر تئوری بر رفتارسلامت محور مرتبط با ستون فقرات در دختران پایه ی پنجم ابتدایی -کارآزمایی میدانی تصادفی کنترل شده
ارزیابی تأثیر برنامه ی آموزشی مبتنی بر تئوری بر رفتارسلامت محور مرتبط با ستون فقرات در دختران پایه ی پنجم ابتدایی -کارآزمایی میدانی تصادفی کنترل شده
Recruitment centers
#1
Name of recruitment center - English: Elementary School Girls in District 22 of Tehran
Name of recruitment center - Persian: مدارس ابتدایی دخترانه منطقه 22 تهران
Full name of responsible person - English: District Education Management 5
Full name of responsible person - Persian: مدیریت آموزش وپرورش منطقه 5
Street address - English: Shahid Sattari Highway, Ferdowsi Avenue, District Education Department 5
Street address - Persian: بزرگراه شهید ستاری، خیابان فردوسی، اداره آموزش و پرورش منطقه 5
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 111-14115
Phone: +98 21 4407 2006
Fax: +98 21 4408 9140
Email: z-akbari@modares.ac.ir
Web page address: https://www.TEHRANEDUS.ir
Name of recruitment center - English: Elementary School Girls in District 22 of Tehran
Name of recruitment center - Persian: مدارس ابتدایی دخترانه منطقه 22 تهران
Full name of responsible person - English: District Education Management 5
Full name of responsible person - Persian: مدیریت آموزش وپرورش منطقه 5
Street address - English: District Education Department,Ferdowsi Avenue, Shahid Sattari Highway,
Street address - Persian: بزرگراه شهید ستاری، خیابان فردوسی، اداره آموزش و پرورش منطقه 5
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 111-14115
Phone: +98 21 4407 2006
Fax: +98 21 4408 9140
Email: z-akbari@modares.ac.ir
Web page address: https://www.TEHRANEDUS.ir
Name of recruitment center - English: Elementary School Girls in District 22 of Tehran Name of recruitment center - Persian: مدارس ابتدایی دخترانه منطقه 22 تهران Full name of responsible person - English: District Education Management 5 Full name of responsible person - Persian: مدیریت آموزش وپرورش منطقه 5 Street address - English: District Education Department,Ferdowsi Avenue, Shahid Sattari Highway, Ferdowsi Avenue, District Education Department 5 Street address - Persian: بزرگراه شهید ستاری، خیابان فردوسی، اداره آموزش و پرورش منطقه 5 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 111-14115 Phone: +98 21 4407 2006 Fax: +98 21 4408 9140 Email: z-akbari@modares.ac.ir Web page address: https://www.TEHRANEDUS.ir
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Research Deputy of Tarbiat Modares University
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه تربیت مدرس
Full name of responsible person - English: Ali Jafarian Dehkordi
Full name of responsible person - Persian: علی جعفریان دهکردی
Street address - English: Jalal Al-Ahmad Pol Nasr, Tarbiat Modarres University
Street address - Persian: جلال آل احمد پل نصر ، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 111-14115
Phone: +98 21 8801 1001
Fax: +98 21 8800 5035
Email: Res@modares.ac.ir
Web page address: http://www.modares.ac.ir
contact.organization_id:
Name of organization / entity - English: Research Deputy of Tarbiat Modares University
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه تربیت مدرس
Full name of responsible person - English: Ali Jafarian Dehkordi
Full name of responsible person - Persian: علی جعفریان دهکردی
Street address - English: Tarbiat Modarres University,Jalal Al-Ahmad Pol Nasr,
Street address - Persian: جلال آل احمد پل نصر ، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 111-14115
Phone: +98 21 8801 1001
Fax: +98 21 8800 5035
Email: Res@modares.ac.ir
Web page address: http://www.modares.ac.ir
contact.organization_id: Name of organization / entity - English: Research Deputy of Tarbiat Modares University Name of organization / entity - Persian: معاونت پژوهشی دانشگاه تربیت مدرس Full name of responsible person - English: Ali Jafarian Dehkordi Full name of responsible person - Persian: علی جعفریان دهکردی Street address - English: JalalTarbiat Modarres University,Jalal Al-Ahmad Pol Nasr, Tarbiat Modarres University Street address - Persian: جلال آل احمد پل نصر ، دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 111-14115 Phone: +98 21 8801 1001 Fax: +98 21 8800 5035 Email: Res@modares.ac.ir Web page address: http://www.modares.ac.ir
Sharing plan
- Demographic information questionnaire
This section includes the parents' job and educational status, economic status (use of personal car, housing situation and type), as well as two questions about the history of neck pain,and low back pain during last week (yes and no) and receiving a program Prevention of back pain training is already done by contributors (yes and no)
- Knowledge: contains 10 multiple choice questions, with a total score of between zero and ten
- Skills to use of back care principles in daily life (spinal care skill) was assessed through six questions regarding checking weight of the book bag, Use two straps, posture while putting on shoes, doing exercises every day, and postural behaviour while lifting and carrying objects. These questions were rated on a five-point scale (from never to ever) with a higher score indicating a biomechanical favourable spinal care behaviour
-Fear-avoidance beliefs were evaluated through six questions asking whether sitting, swimming, running, participating in physical education, cycling and lifting heavy objects are ‘dangerous’ when having a backache. Questions were rated on a five-point scale
-Self-efficacy towards proper back care behaviour was measured by asking how easy or difficult the following were: participation in physical activity and sports each day, attaining a natural curvature of the spine, minimal loading of the book bag and paying attention to ergonomical postures. Questions were rated on a four-point scale (from difficult to easy); the higher the score, the higher was self-efficacy. At the follow-up, the questionnaire integrated an additional part for subjects of the intervention group asking how frequently they used the back care principles in their current daily live (5-point scale from never to always)
- A practical test was conducted to evaluate performance of back care principles. The test was also based on the assessment developed for Cardon et al.’s 2000 study . Interrater reliability in their study ranged from .79 to .98.The practical assessment consisted of eight tasks assessed on a range of 0 to 48 points.
- Demographic information questionnaire This section includes the parents' job and educational status, economic status (use of personal car, housing situation and type), as well as two questions about the history of neck pain,and low back pain during last week (yes and no) and receiving a program Prevention of back pain training is already done by contributors (yes and no) - Knowledge: contains 10 multiple choice questions, with a total score of between zero and ten - Skills to use of back care principles in daily life (spinal care skill) was assessed through six questions regarding checking weight of the book bag, Use two straps, posture while putting on shoes, doing exercises every day, and postural behaviour while lifting and carrying objects. These questions were rated on a five-point scale (from never to ever) with a higher score indicating a biomechanical favourable spinal care behaviour -Fear-avoidance beliefs were evaluated through six questions asking whether sitting, swimming, running, participating in physical education, cycling and lifting heavy objects are ‘dangerous’ when having a backache. Questions were rated on a five-point scale -Self-efficacy towards proper back care behaviour was measured by asking how easy or difficult the following were: participation in physical activity and sports each day, attaining a natural curvature of the spine, minimal loading of the book bag and paying attention to ergonomical postures. Questions were rated on a four-point scale (from difficult to easy); the higher the score, the higher was self-efficacy. At the follow-up, the questionnaire integrated an additional part for subjects of the intervention group asking how frequently they used the back care principles in their current daily live (5-point scale from never to always) - A practical test was conducted to evaluate performance of back care principles. The test was also based on the assessment developed for Cardon et al.’s 2000 study . Interrater reliability in their study ranged from .79 to .98.The practical assessment consisted of eight tasks assessed on a range of 0 to 48 points.
- پرسشنامه اطلاعات جمعیت شناختی
این بخش مشتمل بر وضعیت شغلی و تحصیلی پدر و مادر، وضعیت اقتصادی (استفاده از خودرو شخصی، وضعیت و نوع مسکن) و همچنین دو پرسش درخصوص سابقه ی گردن درد پشت درد و کمر درد در یک هفته ی گذشته ( بلی و خیر) و دریافت برنامه ی آموزش پیشگیری از درد پشت قبلاً توسط مشارکت کنندگان ( بلی و خیر) خواهد بود
- دانش : شامل 10 سؤال چند گزینهای که مجموع نمرات آن بین صفر تا ده خواهد
- مهارت: از طریق پرسشنامه ی خودگزارشی حاوی شش سؤال در مورد چک کردن وزن کیف، استفاده از دو بند کوله، وضعیت بدنی هنگام پوشیدن کفش، انجام ورزش روزانه و وضعیت بدن هنگام برداشتن و حمل اشیاء ارزیابی میگردد. پرسشها با مقیاس پنج قسمتی (از هیچ وقت تا همیشه) بوده و مجموع نمرات از 6 تا 30 میباشد.
- باورهای پرهیز از خطر: با 6 سؤال در مورد اینکه آیا نشستن، شنا کردن، دویدن، شرکت در فعالیت فیزیکی، دوچرخه سواری و بلند کردن اجسام سنگین موقع پشت درد خطرناک است؟، اندازه گیری میشود. سؤالات بر اساس لیکرت 5 قسمتی بوده و طیف مجموع نمرات آن از 4 تا 16 میباشد.
- خودکارآمدی: با پرسش در مورد چگونگی آسان یا سخت بودن مراقبت از ستون فقرات شامل 4 سؤال با مقیاس چهار قسمتی از مشکل تا آسان) اندازه گیری میشود که طیف مجموع نمرات آن از 4 تا 16 میباشد. در پیگیری های بعد از مداخله نیز از گروه آزمون سؤالی اضافه در مورد دفعات استفاده از اصول مراقبت از ستون فقرات در زندگی روزمره خود میشود (با مقیاس پنج قسمتی از هیچ وقت تا همیشه)
- رفتار : شامل چک لیستی جهت ارزیابی هشت وظیفه مراقبت از ستون فقرات می باشد که توسط کاردون و همکاران در سال 2000 استاندارد گردیده و دارای پایایی بین مشاهده کنندگان 0/79 تا 0/98 می باشد. طیف مجموع نمرات از صفر تا 48 می باشد.
- پرسشنامه اطلاعات جمعیت شناختی این بخش مشتمل بر وضعیت شغلی و تحصیلی پدر و مادر، وضعیت اقتصادی (استفاده از خودرو شخصی، وضعیت و نوع مسکن) و همچنین دو پرسش درخصوص سابقه ی گردن درد پشت درد و کمر درد در یک هفته ی گذشته ( بلی و خیر) و دریافت برنامه ی آموزش پیشگیری از درد پشت قبلاً توسط مشارکت کنندگان ( بلی و خیر) خواهد بود - دانش : شامل 10 سؤال چند گزینهای که مجموع نمرات آن بین صفر تا ده خواهد - مهارت: از طریق پرسشنامه ی خودگزارشی حاوی شش سؤال در مورد چک کردن وزن کیف، استفاده از دو بند کوله، وضعیت بدنی هنگام پوشیدن کفش، انجام ورزش روزانه و وضعیت بدن هنگام برداشتن و حمل اشیاء ارزیابی میگردد. پرسشها با مقیاس پنج قسمتی (از هیچ وقت تا همیشه) بوده و مجموع نمرات از 6 تا 30 میباشد. - باورهای پرهیز از خطر: با 6 سؤال در مورد اینکه آیا نشستن، شنا کردن، دویدن، شرکت در فعالیت فیزیکی، دوچرخه سواری و بلند کردن اجسام سنگین موقع پشت درد خطرناک است؟، اندازه گیری میشود. سؤالات بر اساس لیکرت 5 قسمتی بوده و طیف مجموع نمرات آن از 4 تا 16 میباشد. - خودکارآمدی: با پرسش در مورد چگونگی آسان یا سخت بودن مراقبت از ستون فقرات شامل 4 سؤال با مقیاس چهار قسمتی از مشکل تا آسان) اندازه گیری میشود که طیف مجموع نمرات آن از 4 تا 16 میباشد. در پیگیری های بعد از مداخله نیز از گروه آزمون سؤالی اضافه در مورد دفعات استفاده از اصول مراقبت از ستون فقرات در زندگی روزمره خود میشود (با مقیاس پنج قسمتی از هیچ وقت تا همیشه) - رفتار : شامل چک لیستی جهت ارزیابی هشت وظیفه مراقبت از ستون فقرات می باشد که توسط کاردون و همکاران در سال 2000 استاندارد گردیده و دارای پایایی بین مشاهده کنندگان 0/79 تا 0/98 می باشد. طیف مجموع نمرات از صفر تا 48 می باشد.
Protocol summary
Study aim
The purpose of this study is" Designing an educational program based on theory and its impact on healthy spine- related behavior in female fifth grade elementary school in capital Tehran`s region 22".
Design
The study population included 102 public elementary schools fifth grade girls, Tehran 22nd District, has inclusion criteria,with the pre and post-test in the academic year 97-98. At first, two similar schools were selected and are randomly assigned to control and test group. Then in each school, two classes are randomly selected and in each group, 51 eligible people are enrolled in the study.
Settings and conduct
Before intervention, a localized questionnaire based on the four constructs of social cognitive theory (behavioral capability, self-efficacy, beliefs and behavior), validity and reliability of which were previously measured, will be completed by the two groups.After performing 6 educational intervention sessions in the test group,Immediately, three and six months after the intervention, the questionnaire will again be filled in by the two groups.The effects of the intervention are compared with control group.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Fifth grade female student; parental written consent for student participation in the study; informed consent and voluntary; participation of the student in the study; ability to attend training sessions; no training in this area.
Exclusion Criteria: having pain or disorder in the student's spine; disapproval of student's spine health by physiotherapist.
Intervention groups
Intervention group: Includes 51 people who receive instructional education based on 4 construct of social cognitive theory. The control group also includes 51 people who will not receive any intervention.
Main outcome variables
Healthy spine-related behavior
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180528039885N1
Registration date:2018-10-30, 1397/08/08
Registration timing:registered_while_recruiting
Last update:2019-06-17, 1398/03/27
Update count:1
Registration date
2018-10-30, 1397/08/08
Registrant information
Name
Zahra Akbari chehrehbargh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 4602 3277
Email address
z-akbari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of a theory-based educational program on healthy spine-related behavior among female fifth grade elementary school - Randomized Community Trial
Public title
Effectiveness of a theory-based educational program on healthy spine-related behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female fifth grade elementary school
Parents informed consent
Student informed consent and voluntary participation
Ability to attend training sessions
No training in this area
Exclusion criteria:
Receive back pain prevention programs before or outside of this study
Any reports of pain or disorder in the student's spine by him or her, parents or school officials
Report of student's spine unhealthy by physiotherapist
Age
From 11 years old to 11 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
Because the trial is done on the group and the community ,in the first stage of the sampling process, a list of schools in the study location was prepared which included nine schools in the study location.
As the second step, two schools of 9 schools -which is similar In terms of social class and the number of students in the class- are randomly assigned to the intervention and control groups using the simple random sampling technique .
As the final step, two classes of fifth grade in each school - 51 students regarding the inclusion and exclusion criteria - are randomly selected to enter the study .
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 in Tarbiat Modarres University
Street address
Tarbiat Modarres University, Jalal Ahmad Highway,
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.TMU.REC.1396.727
Health conditions studied
1
Description of health condition studied
back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Healthy spine-related behavior
Timepoint
before, Immediate, three and six months after the intervention
Method of measurement
Using a questionnaire
Secondary outcomes
1
Description
Knowledge, Skill, Self-efficacy and Belief.
Timepoint
before, Immediate, three and six months after the intervention
Method of measurement
Using a performance checklist
Intervention groups
1
Description
Intervention group: Includes 51 people who receive 6 sessions of instructional education program based on social cognitive theory. Two strategies( 3 sessions) are used to increase the behavioral capability(knowledge and skills):- Provide required knowledge to conduct recommended behavior using lecture, slide show and brain storm 2- Teaching essential skills for accepting the behavior and keeping it using the direct and vicarious experience and demonstration- re demonstration method In order to increase self-efficacy are used (2 sessions) , methods of mastering the practice, observing others' performance, receiving suggestions from others, and confronting emotions arising from thoughts of change . To enhance the fear-avoidance beliefs (1 sessions) are used the methods of discussing about benefit, brainstorm , and role playing .
Category
Prevention
2
Description
Control group: Includes 51 people (two classes) who are in the same school as the intervention group and do not receive any training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Elementary School Girls in District 22 of Tehran
Full name of responsible person
District Education Management 5
Street address
District Education Department,Ferdowsi Avenue, Shahid Sattari Highway,
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 4407 2006
Fax
+98 21 4408 9140
Email
z-akbari@modares.ac.ir
Web page address
https://www.TEHRANEDUS.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tarbiat Modares University
Full name of responsible person
Ali Jafarian Dehkordi
Street address
Tarbiat Modarres University,Jalal Al-Ahmad Pol Nasr,
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8801 1001
Fax
+98 21 8800 5035
Email
Res@modares.ac.ir
Web page address
http://www.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of 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
Department of Health Education,Faculty of Medical Sciences, Tarbiat Modares University ،
Full name of responsible person
Sediqh al-Sadat Tawafian
Position
Professor of Health Education & Promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University,Jalal Al Ahmad, Paul Nasr
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 3590
Fax
+98 21 8288 4555
Email
tavafian@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Health Education, Faculty of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Sediqh al-Sadat Tawafian
Position
Professor of Health Education & promotion
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education ,School of Medical Sciences,Tarbiat Modares University, Jalal Allahmad, Paul Nasr
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 8288 3590
Fax
+98 21 8288 4555
Email
tavafian@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Department of Health Education, School of Medical Sciences, Tarbiat Modares University
Full name of responsible person
Zahra Akbari Chehrehbargh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
Department of Health Education, School of Medical Sciences, Tarbiat Modares University, Jalal Allahmad, Paul Nasr
City
Tehran
Province
Tehran
Postal code
111-14115
Phone
+98 21 4602 3277
Fax
+98 21 8288 4555
Email
z-akbari@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
When the data will become available and for how long
31/ 09/2020
To whom data/document is available
The person who evaluates the outcome - Analytic person - Journal Reviewer - executor of plan
Under which criteria data/document could be used
To evaluate the outcome, data analysis and validation of data - Under the conditions of the triple-blind
From where data/document is obtainable
executor of plan
What processes are involved for a request to access data/document
It is requested by e-mail to the project implementer with the address: tavafian@modares.ac.ir