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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
The experimental group will be given training on ergonomic risk factors.
Other: ergonomic risk management awareness training
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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