- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322692
Effect Nurse-Led PRECEDE-PROCEED Model Based Risk Management Program on Reducing Musculoskeletal Symptoms in Primary School Children
December 22, 2025 updated by: Makbule Senel, Istanbul University - Cerrahpasa
The Effect of Nurse-Led PRECEDE-PROCEED Model-Based Risk Management Program on Reducing Musculoskeletal Symptoms in Primary School Children
The Effect of a Nurse-Led Ergonomic Risk Management Program Based on the PRECEDE-PROCEED Model on Reducing Musculoskeletal Symptoms in Primary School Children
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary school children spend a large portion of their school hours sitting at their desks (Chen 2021, Van Delden 2020).
Students are associated with musculoskeletal pain and discomfort due to prolonged sitting (Guelfi 2019).
Common causes of these musculoskeletal system (MSS) problems include carrying inappropriately heavy backpacks, sitting for extended periods in the classroom, long class hours, standardized desks and seats, excessive homework, and prolonged use of phones, tablets, and computers outside of homework.
These factors contribute to MSS problems in children, particularly musculoskeletal pain and posture disorders.
It is known that the prevalence of posture disorders in school children is increasing (Kinaci 2018).
55.5% of students reported having to lean over their desks while writing at school, and 58.1% reported discomfort due to the weight of their school bags (Yılmaz 2018).
Because school-aged children are in the developmental stage of MSD and body posture is being shaped, if proper ergonomic adjustments and behavioral development interventions are not implemented during this period, significant health problems can occur in later years (Contardo 2016).
Therefore, interest in school ergonomic intervention programs and their effects on MSD is increasing globally (Sellschop 2015).
There is an urgent need for ergonomics-specific and behavior-based school programs (Ayed 2019).
Research suggests that school nurses should be involved in these school health programs.
To prevent MSD problems, they should collaborate with teachers to organize educational programs on posture training, weight-bearing methods, and the importance of exercise.
They should also implement ergonomic adjustments in the classroom and regularly reiterate these recommendations with school administrators and guidance counselors (Yılmaz 2018).
Therefore, this study aims to determine the effectiveness of a nurse-led ergonomic risk management education program based on the PRECEDE-PROCEED model on reducing MSD symptoms in primary school children.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Makbule Şenel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being a student,
- Being in the 3rd or 4th grade,
- Volunteering to participate in the research,
- Volunteering with parental consent,
- No musculoskeletal problems,
- No physical disabilities that would prevent exercise,
Exclusion Criteria:
- Those diagnosed with a chronic disease
- Those with musculoskeletal problems
- Those with physical disabilities that may prevent them from exercising
- Those who volunteer but do not have parental permission
- Those who have parental permission but do not volunteer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
The experimental group will be given training on ergonomic risk factors.
|
For 4 weeks, the experimental group will be trained on ergonomic risk factors (moving in appropriate posture, using ergonomic desks and chairs, carrying a backpack of appropriate weight according to body mass index (BMI), etc.).
|
|
No Intervention: control grup
No attempt was made to initiate the training process
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Evaluation
Time Frame: The 4th week
|
It evaluates effort, repetition frequency, and duration of work at the upper arm, lower arm, wrist, neck, and trunk.
Each site is assigned an Ergonomic Risk Score (ERP) from 1 to 4, with ERP 1 indicating acceptable risk, ERP 2 indicating risk requiring further investigation, ERP 3 indicating serious risk requiring immediate intervention and remediation, and ERP 4 indicating highest risk requiring immediate change.
|
The 4th week
|
|
Musculoskeletal Disorders Evaluation
Time Frame: The 4th week
|
The survey assesses frequency, severity, and work-relatedness, and calculates a total discomfort score.
Frequency is scored as "Never" = 0; 1-2 times a week = 1.5; 3-4 times a week = 3.5; Once a day = 5; Several times a day = 10; severity is scored as "little" = 1, moderate = 2, and severe = 3; and work-relatedness is scored as "little" = 1, moderate = 2, and severe = 3.
The total discomfort score frequency x severity x work relevance of discomfort).
|
The 4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Upper Extremity Evaluation
Time Frame: The 12th week
|
It evaluates effort, repetition frequency, and duration of work at the upper arm, lower arm, wrist, neck, and trunk.
Each site is assigned an Ergonomic Risk Score (ERP) from 1 to 4, with ERP 1 indicating acceptable risk, ERP 2 indicating risk requiring further investigation, ERP 3 indicating serious risk requiring immediate intervention and remediation, and ERP 4 indicating highest risk requiring immediate change.
|
The 12th week
|
|
Musculoskeletal Disorders Evaluation
Time Frame: The 12th week
|
The survey assesses frequency, severity, and work-relatedness, and calculates a total discomfort score.
Frequency is scored as "Never" = 0; 1-2 times a week = 1.5; 3-4 times a week = 3.5; Once a day = 5; Several times a day = 10; severity is scored as "little" = 1, moderate = 2, and severe = 3; and work-relatedness is scored as "little" = 1, moderate = 2, and severe = 3.
The total discomfort score frequency x severity x work relevance of discomfort).
|
The 12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2022
Primary Completion (Actual)
January 20, 2024
Study Completion (Actual)
June 20, 2025
Study Registration Dates
First Submitted
October 1, 2025
First Submitted That Met QC Criteria
December 22, 2025
First Posted (Actual)
January 7, 2026
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
December 22, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- İUC-FNFN-MS-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
2022- 2025
IPD Sharing Access Criteria
2025
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Primary School Children
-
Hannover Medical SchoolActive, not recruitingPrimary School ChildrenGermany
-
Maastricht University Medical CenterCompletedHealth and Wellbeing of Primary School-aged ChildrenNetherlands
-
Universidad de San Martín de PorresNot yet recruitingPromote a Critical Attitude Towards the Symbolic Consumption of Youghurt in Primary School Children
-
Universidad de ConcepcionEnrolling by invitationMental Health | School Health | School-age ChildrenChile
-
Al-Zaytoonah University of JordanRecruitingOver Weight | School Age ChildrenEgypt
-
Linnaeus UniversityKarolinska Institutet; Uppsala University; Stockholm University; KTH Royal Institute... and other collaboratorsRecruitingWell-being in Elementary School Children | Mental Health in Elementary School Children | Work-related Stress in Teachers | Academic Performance in Elementary School ChildrenSweden
-
Universidade do PortoCenter for Health Technology and Services ResearchCompletedUrinary Iodine Status in School Aged ChildrenPortugal
-
University of Pau and Pays de l'AdourCompletedPhysical Activity | Children | Sedentary Behavior | School-based Intervention
-
Hong Kong Baptist UniversityThe Hong Kong Jockey Club Charities Trust; SF&OC Sports LegacyNot yet recruiting
-
University of ManitobaCompletedHealthy Children | Elementary School Age | Rural and Urban | First NationsCanada
Clinical Trials on ergonomic risk management awareness training
-
Qassim UniversityUniversity of TabukRecruiting
-
Kutahya Health Sciences UniversityNot yet recruitingPain | Sleep | Anxiety StateTurkey (Türkiye)
-
Jer-Hao ChangCompletedMusculoskeletal DisordersTaiwan
-
Forschungsinstitut für Balneologie und Kurortwissenschaft...European Union; Federal ministry of labour and social affairsCompleted
-
National Research Centre for the Working Environment...CompletedMusculoskeletal DisordersDenmark
-
Universiti Putra MalaysiaCompletedLow Back Pain | Musculoskeletal Pain
-
Foundation University IslamabadRecruiting
-
Virginia Commonwealth UniversityCompletedOccupational InjuriesUnited States
-
University of FloridaRecruiting
-
University of Nevada, Las VegasRecruitingNo Disease or Condition is Being StudiedUnited States