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Trial registered on ANZCTR

Registration number

ACTRN12618000720213

Ethics application status

Not required

Date submitted

2/03/2018

Date registered

2/05/2018

Date last updated

13/03/2020

Date data sharing statement initially provided

1/08/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

PosturalMind - Postural Education in the prevention of musculoskeletal pain and postural changes in children in the basic school

Scientific title

PosturalMind - Postural Education in the prevention of musculoskeletal pain and postural changes in children in the basic school

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1209-7931

Trial acronym

PECBPHaMPiSAC

Linked study record

The present study was considered as a continuation of the research developed under the name Postural education: the relationship between Postural habits and musculoskeletal pain in children of basic education and clinical trial registration number ACTRN12616001365459

Health condition

Health condition(s) or problem(s) studied:

Postural behavior

Musculoskeletal pain

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Postural habits are considered one of the main risk for the development of musculoskeletal disorders in adults, in order to that is emergent preventive measures in childhood (Braccialli & Vilarta, 2017; Desouzart, Filgueiras, Matos, & Dagge, 2016).
Physical activity and postural habits are very important to maintain healthy body free from pain, so is important that schools have educational program with preventive approach, designed to be implemented in the environment school.
The intervention is made in Postural educational group - back school intervention according Zachrisson (1981).
Postural education group - This program will be held during citizenship and civics classes, with a frequency of 30 minutes once a week for 8 weeks. These sessions will be conducted by the principal investigator, PhD in human kinetics, and by two collaborating researchers and are made in group. These attitudes were reinforced with meetings held by the principal investigator, and teachers role of observing the posture of his students and guides them when they are inadequate, indicating the ideas postures provided in study sessions and use class attendance checklists.
The postural educational group according education program recommends the following next steps:
- Sitting: Maintenance of standing back against the back of the chair; positioning the region of the closest possible glutes of the chair and your feet flat on the floor. Where the chair did not allow proper support of the feet on the ground, the students were asked to put a support (books, shoe box);
- Standing with the upright head; back straight and feet apart at shoulder width;
- Lying in lateral decubitus cushion in the head with a height equal to distance between the shoulder and neck and pillow between your legs;
- Carry a backpack with a strap on each shoulder, avoid carrying more than 10% by body weight.
- Survey and object transfer: proper way to pick up objects on the floor: perform the activity bending your knees and not the spine; correct way to transfer objects from one place to another, stand in front of the object, hold it with both hands and close to the body, avoiding twisting the trunk.
The aim of this study is analyze the postural intervention in the prevention of musculoskeletal pain and postural changes in children in the 2nd and 3rd cycle of elementary education. It is believed that postural education habits also play an essential role in children's health, and the Back-school program or the gamification program may be responsible for bringing postural education to the school context, with different preventive strategies for application in the daily life of children.

Intervention code [1]

Lifestyle

Intervention code [2]

Treatment: Other

Comparator / control treatment

no treatment, maintaining the same postural habits and answer the questionnaire at baseline and after 4 weeks and 8 weeks

Control group

Active

Outcomes

Primary outcome [1]

Analysis a musculoskeletal pain assessment in school age children using questionnaire according to Body Discomfort Scale (Corlett and Bishop, 1976) in order to verify and categorize the pain felt (where 0 corresponded to no pain and 5 to the full amount of pain felt by the subject), and its duration (acute pain, subacute or chronic pain).

Timepoint [1]

At baseline

Primary outcome [2]

Analysis an initial postural behavior assessment in school age children using questionnaire according to Postural behavior questionnaire (Rebolho, 2005) and postural changes during the school year.

Timepoint [2]

At baseline

Secondary outcome [1]

Analyse whether ergonomics postural recommended were implemented, there will be assessed by a personal or telephone contact with teachers and parents

Timepoint [1]

Once a weeks during eight weeks after ergonomics postural recommended .

Secondary outcome [2]

Postural habits as assessed by questionnaire according to Postural behavior questionnaire (Rebolho, 2005)

Timepoint [2]

4 weeks and 8 weeks after ergonomics postural recommended

Secondary outcome [3]

Musculoskeletal pain as assessed by questionnaire according to Body Discomfort Scale (Corlett and Bishop, 1976).

Timepoint [3]

4 weeks and 8 weeks after ergonomics postural recommended.

Eligibility

Key inclusion criteria

- Young and teenager
- Belonging to the 2nd Basic Education Cycle and the 3rd Basic Education Cycle
- Belonging to the basic schools of the district of Viseu, Leiria and Coimbra
- Students that the parents consented, were analyzed

Minimum age

9 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Children with psychiatric disorders compromising locomotion, communication and performance of Daily Life Activities
- Neurological pathology.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Not applicable

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Not applicable

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

For this purpose, all students in the 2nd and the 3rd Basic Education Cycle of schools in the districts of Viseu will be invited to participate in this study.
SPSS, 26.0 version will be used in order to treat all the statistical data, for normality verification Kolmogorov-Smirnov test was applied before a descriptive analysis. This last, will be calculated based upon standard methods. In order to analyze any characteristically difference between both groups, the t test will be applied. In order to find variable relations Pearson’s correlate coefficient (r) will be applied. The statistically level of significance will be established in p= 0.05.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

13/04/2020

Actual

Date of last participant enrolment

Anticipated

17/04/2020

Actual

Date of last data collection

Anticipated

19/06/2020

Actual

Sample size

Target

200

Accrual to date

Final

Recruitment outside Australia

Country [1]

Portugal

State/province [1]

Viseu

Funding & Sponsors

Funding source category [1]

University

Name [1]

RECI (Research in Education and Community Intervention)

Address [1]

Piaget Institute of Viseu - Estarda do Alto do Gaio 3515-776 Galigonge, Lordosa - Viseu

Country [1]

Portugal

Primary sponsor type

University

Name

RECI (Research in Education and Community Intervention)

Address

Piaget Institute of Viseu - Estarda do Alto do Gaio 3515-776 Galigonge, Lordosa - Viseu

Country

Portugal

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

none

Country [1]

Ethics approval

Ethics application status

Not required

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This research project, is about the use of postural education as tools for postural intervention and reeducation of postural behavior with a focus on musculoskeletal pain and changes in posture habits in children and adolescents allows the establishment of criteria in health care in individuals in the stage of growth and maturation.
This study aims to analyze the effects of postural intervention through postural education and its relation with the symptoms of musculoskeletal pain and postural changes during the day.
Without this, a high financial investment, with the training of health professionals linked to the primary health system and, in accordance with the national and international public health intervention directives, with the intervention applied on the prevention and of the information of the practice of ideal health habits, in this case, of good postural habits.
This study has the following specific objectives:
- Evaluate the effect of a postural education program and its influence on the flexibility and good practices of postural behavior during the activities of daily living;
- To evaluate the effect of a postural education program and its influence on the musculoskeletal pain reported during the activities of daily living;
The method applied is a consequence of a previous investigation by the principal investigator, where there was a relationship between motor behavior in sleeping posture in young adults and an increase in sleep quality indices (Desouzart, Filgueiras, & Matos, 2015), as well as in studies with the young population in the analysis of postural habits (Desouzart, Filgueiras, Matos, & Dagge, 2016; Desouzart & Gagulic, 2017). In the study of motor behavior in sleeping posture in young adults (Desouzart, Filgueiras and Matos, Submitted), there was a significant reduction of complaints of musculoskeletal back pain (p = .002), a significant increase in sleep quality (p = .013) and quality of life (p = .001). Regarding postural habits, 88.5% of participants had poor posture, and these significantly (p <0.01), higher perception of pain (2.44+/- 0.98) compared with participants with adequate postures (2,06+/- 0.83). The relations obtained seem to prove the crucial role that postural education can have in therapeutic/reeducation terms, and especially in terms of prevention.

Trial website

Trial related presentations / publications

Public notes

The present study was considered as a continuation of the research developed under the name Postural education: the relationship between Postural habits and musculoskeletal pain in children of basic education, in which it has already obtained prior approval from the Ethics Committee Research Center for Human Movement Sciences (CIMH) the number 03/2014 and subsequent clinical trial registration number ACTRN12616001365459, reason why its ethical application status was considered "Not required"

Contacts

Principal investigator

Name

Prof Gustavo Desouzart

Address

Piaget Institute of Viseu
Estrada do Alto do Gaio 3515-776 Galifonge, Lordosa - Viseu

Country

Portugal

Phone

+351911973370

Fax

[email protected]

Contact person for public queries

Name

Gustavo Desouzart

Address

Piaget Institute of Viseu
Estrada do Alto do Gaio 3515-776 Galifonge, Lordosa - Viseu

Country

Portugal

Phone

+351232910100

Fax

[email protected]

Contact person for scientific queries

Name

Gustavo Desouzart

Address

Piaget Institute of Viseu
Estrada do Alto do Gaio 3515-776 Galifonge, Lordosa - Viseu

Country

Portugal

Phone

+351232910100

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Due to data protection law, no individual data of the participant will be made available in any means of disclosure or publication.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
3497	Informed consent form					374586-(Uploaded-26-07-2019-18-55-10)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically