Trial Review

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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] 294151 0
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 306778 0
Musculoskeletal pain 307351 0
Condition category
Condition code
Musculoskeletal 305872 305872 0 0
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] 300438 0
Lifestyle
Intervention code [2] 300862 0
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] 304989 0
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] 304989 0
At baseline
Primary outcome [2] 304990 0
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] 304990 0
At baseline
Secondary outcome [1] 343813 0
Analyse whether ergonomics postural recommended were implemented, there will be assessed by a personal or telephone contact with teachers and parents
Timepoint [1] 343813 0
Once a weeks during eight weeks after ergonomics postural recommended .
Secondary outcome [2] 343814 0
Postural habits as assessed by questionnaire according to Postural behavior questionnaire (Rebolho, 2005)
Timepoint [2] 343814 0
4 weeks and 8 weeks after ergonomics postural recommended
Secondary outcome [3] 343815 0
Musculoskeletal pain as assessed by questionnaire according to Body Discomfort Scale (Corlett and Bishop, 1976).
Timepoint [3] 343815 0
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] 9639 0
Portugal
State/province [1] 9639 0
Viseu

Funding & Sponsors
Funding source category [1] 298789 0
University
Name [1] 298789 0
RECI (Research in Education and Community Intervention)
Country [1] 298789 0
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] 297969 0
None
Name [1] 297969 0
none
Address [1] 297969 0
none
Country [1] 297969 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 299734 0
Ethics committee address [1] 299734 0
Ethics committee country [1] 299734 0
Date submitted for ethics approval [1] 299734 0
Approval date [1] 299734 0
Ethics approval number [1] 299734 0

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 81402 0
Prof Gustavo Desouzart
Address 81402 0
Piaget Institute of Viseu
Estrada do Alto do Gaio 3515-776 Galifonge, Lordosa - Viseu
Country 81402 0
Portugal
Phone 81402 0
+351911973370
Fax 81402 0
Email 81402 0
[email protected]
Contact person for public queries
Name 81403 0
Prof Gustavo Desouzart
Address 81403 0
Piaget Institute of Viseu
Estrada do Alto do Gaio 3515-776 Galifonge, Lordosa - Viseu
Country 81403 0
Portugal
Phone 81403 0
+351232910100
Fax 81403 0
Email 81403 0
[email protected]
Contact person for scientific queries
Name 81404 0
Prof Gustavo Desouzart
Address 81404 0
Piaget Institute of Viseu
Estrada do Alto do Gaio 3515-776 Galifonge, Lordosa - Viseu
Country 81404 0
Portugal
Phone 81404 0
+351232910100
Fax 81404 0
Email 81404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
3497Informed 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.